A GLUTEN FREE GROCERY PROGRAM FOR WOMEN’S MENTAL HEALTH AND SEX/GENDER DIFFERENCES RESEARCH AntoiDominique Nichole Pilar Vaccaro B.S., California State University, Sacramento, 2005 PROJECT Submitted in partial satisfaction of the requirements for the degree of MASTER OF ARTS in EDUCATION (Special Education) at CALIFORNIA STATE UNIVERSITY, SACRAMENTO FALL 2010 A GLUTEN FREE GROCERY PROGRAM FOR WOMEN’S MENTAL HEALTH AND SEX GENDER DIFFERENCES RESEARCH A Project by AntoiDominique Nichole Pilar Vaccaro Approved by: __________________________________, Committee Chair Rachel Gonzales Ed.D. _________________________ Date ii Student: AntoiDominique Nichole Pilar Vaccaro I certify that this student has met the requirements for format contained in the University format manual, and that this project is suitable for shelving in the Library and credit is to be awarded for the Project. _________________________, Graduate Coordinator ______________________ Bruce Ostertag Ed.D. Date Department of Special Education, Rehabilitation, School Psychology, & Deaf Studies iii Abstract of A GLUTEN FREE GROCERY PROGRAM FOR WOMEN’S MENTAL HEALTH AND SEX/GENDER DIFFERNCES RESEARCH by AnotiDominique Nichole Pilar Vaccaro This Women’s Mental Health and Sex/Gender Differences Research (R21) is written to allow a one year study for women diagnosed with bipolar disorder and provide the implementation of a Gluten Free Grocery Program (GFGP) to reduce the symptoms and side effects of psychotropic medications associated with bipolar disorder as defined by the DSM-IV. To address the problem of lack of adequate treatments and alternative methods for women with bipolar disorder the implementation of a Gluten Free Grocery Program, is to be administered for the course of one year in the San Francisco and East Bay area. The goal is to allow women a choice to current psychotropic drugs that have proven to be harmful and consistently cause severe side effects, which essentially stops women from the use of any treatment. This program is aimed to increase the levels of functionality of the participants both mentally and emotionally to regain more functionality and life vitally. _______________________, Committee Chair Rachel Gonzales Ed.D. _______________________ Date iv Dedication This work is dedicated to my ancestors the red, white, brown, black, yellow and those from other worlds. I want to acknowledge the depths of my multicultural background. It has been an interesting journey of my spirit and soul to be an old soul time traveler in a young soul world. To my Savage grandparents (George W. and Mamie) for my aristocratic class level intellect, strength, showing and teaching me love. To my mother, Juanita Savage-Boyd for offering the truth and not allowing anyone to assign me feelings. To my Aunt Joyce A. Lee, for all the financial support. To my favorite cousin, Christopher Michael Savage. But mostly, to my sister, best friend, fashion designer old soul Quesstonnal Carmen Emanuelle Reed, I love you infinity. I could not have come this far without you. Our gluten free lifestyle has lead to great health, and incredible wealth. Also to Dr. Anthony Ramsey-Wallace, Dr. Todd Koch, Phil Hitchcock, Dr. Bernice Bass de Martinez, Dr. Rachael Gonzales, Dr. Kaylene Richards-Ekeh for your assistance, support and inspiration. Thanks, to the stardust from those celebrities who believe in me and offer financial support. To my spirit guides for keeping me in belief and in practice of magic. To anyone who I may have forgot that offered me positively energy. Lastly, to my future husband and children (if any), you may manifest! I can close this chapter and open a new one! v TABLE OF CONTENTS Page Dedication ..............................................................................................................................v Chapter 1. INTRODUCTION…. ........................................................................................................ 1 Statement of the Problem………….………………………………………….. ............ 4 Purpose…………………………………………………………………………….... .. 5 Delimitations of the Project………………………………………………………….. 6 Definition of Terms…………………………………………………..……………..... 7 2. REVIEW OF THE LITERATURE ...................................................................................17 Specific Gender Needs for Women with Bipolar Disorder ..........................................18 Alternative Treatments to Psychiatric Medications ......................................................22 Study One......................................................................................................................28 Study Two .....................................................................................................................29 Study Three ...................................................................................................................29 Benefits of Gluten Free Diet for Women with Bipolar Disorder..................................30 Variables that Exacerbate Bipolar Disorder .................................................................30 Symptoms of Gluten Allergies......................................................................................31 Summary .......................................................................................................................32 vi 3. METHODOLOGY ............................................................................................................34 Request for Application ................................................................................................34 Description of a Model .................................................................................................34 Program Services ..........................................................................................................35 Program Staffing ..........................................................................................................36 Evaluations ....................................................................................................................36 Organizational Structure ...............................................................................................36 Summary .......................................................................................................................37 4. CONCLUSIONS................................................................................................................38 Summary .......................................................................................................................39 Recommendations .........................................................................................................39 5. RESOURCES FOR NATURAL ALTERNATIVES FOR HEALING .............................41 Appendix: A Gluten Free Grocery Program Grant for Women’s Mental Health and Sex/Gender Differences Research...........................................................48 Gluten Free Grocery Program Grant for Women’s Mental Health and Sex/Gender Differences Research .............................................................................................................49 Project Abstract .....................................................................................................................49 Problem Statement ................................................................................................................50 Target Population ...................................................................................................................50 Literature Review...................................................................................................................51 Goals and Objectives .............................................................................................................52 vii Working Hypotheses ..............................................................................................................56 Methods, Strategies and Program Design ..............................................................................56 Evaluations .............................................................................................................................57 Objectives of the Evaluation ..................................................................................................57 Information Management System ..........................................................................................57 Impact Evaluation ..................................................................................................................58 Organizational Structure ........................................................................................................58 Project Management and Staffing ..........................................................................................58 Budget and Budget Justifications...........................................................................................60 References ..............................................................................................................................62 viii 1 Chapter 1 INTRODUCTION The Problem Bipolar disorder occurs with great frequency and spans the nation (National Alliance of Mental Illness [NAMI], 2009). Approximately 12 million women in the United States live with a diagnosis of bipolar disorder (National Mental Health Association, 2005). The importance of this level of prevalence is obvious when one considers that individuals diagnosed with a bipolar disorder may experience symptoms including sluggishness, fatigue, exhaustion, feelings of hopeless or depression, disturbances with appetite and sleep, confusion, uncontrollable crying, fear of harming self, mood swings, racing thoughts and elevated moods (American Psychiatric Association, 2006). Moreover, the symptoms of bipolar disorder can not only have debilitating effects on a mother, but also on the well being of her children and family (Stegler, 2008). For example, children of mothers diagnosed with bipolar disorder have an increased likelihood of developing attachment disorders, behavior problems, developmental delays, and health issues (Kroll, 2007). In addition to the symptoms identified above, many women with bipolar disorders suffer from allergies to food (Marohn, 2005). This is of importance because evidence exists that food allergies may exacerbate bipolar symptoms (Marohn). The significance of this problem with food allergies in the presence of a bipolar disorder is demonstrated by research by Nambudripad Allergy Elimination Technique (NAET) practitioners who 2 have found that the elimination of allergies can in some cases reverse bipolar disorder and other mental illness (Marohn). Eliminating the effects of food allergies involves a twofold benefit for individuals with mental illness (Hall, 2007). Removing the source of the allergy eliminates the acute response/increase in symptoms. In addition, removal of the allergy-causing substance tends to improve the individual’s digestion of the proper nutrients, thereby addressing underlying deficiencies that exacerbate bipolar symptomatology (Hall). Given the knowledge that food allergies can cause bipolar symptoms, it would seem to be an obvious issue to address for people diagnosed with a bipolar disorder. However, many times people are not aware of their allergies. The allergy goes undetected and the chronic reaction begins to create energy blockage, which leads to panoply of symptoms, including those of bipolar disorder, clinical depression, and schizophrenia (Marohn, 2005). On the other hand, there exist documented nutritional, diet alternative therapies that can be utilized when treating bipolar disorder (Truehope, 2005). Providing adequate alternative treatment and accessible mental health services to women with bipolar disorders in need of mental health services has been a challenge (Null, 2003). Without more adequate and effective alternative mental health services programs, families run the risk of destructive parent-child interaction, which impacts the health and well being of children and increases the potential for child neglect and abuse 3 (Null, 2003). By assisting the population of women with bipolar disorders, we then may affect the dynamic of the whole family unit in a positive manner (Null). One food product to which some women are allergic is gluten. Gluten is difficult to digest, and many people develop intolerance to it, this means the body regards it as a foreign substance and because of this intolerance, the immune system launches an immune reaction against gluten (Shepard, 2008). Moreover, as a result of this process, allergies can produce mental and behavioral symptoms as gluten causes inflammation in brain (Shepard). Similarly, psychiatric medications can make psychotic symptoms worse and/or increase the likelihood of having psychotic symptoms (Hall, 2007). Psychiatric medications can change receptors for such neurotransmitters as dopamine, making a person “increasing sensitive to psychotic behavior, also it can increase sensitivity to emotions and experiences in general” (Hall). Some people with bipolar disorder report their first psychotic symptoms occurred after starting to take psychiatric drugs (Hall). In furtherance of the notion that the above-described issues are of importance, it should be noted that mental illness is the second leading cause of disability and premature mortality in the U.S and other developed countries (Marohn, 2005). In 2002, in the U.S one in four hospital admissions were psychiatric patients (Marohn). A major reason why treatments of mental disorder have had modest success is that the emphasis has been placed on pharmaceuticals and not the use of alternative methods that have proven in the past to be successful (Hall, 2007). Extreme mood swings occurring within a single day may typify the patient with gluten allergy (Pfeiffer, 2007). These moods may be mania or 4 deep depression and can correspond with the ingestion of foods (Pfeiffer). If women diagnosed with bipolar disorders are allergic to gluten products, paranoia and abnormal thinking can occur within twenty-four hours of ingestion (Pfeiffer). Allergies can upset levels of hormones and other key chemicals in the brain, resulting in symptoms ranging from depression, bipolar disorder and schizophrenia (Pfeiffer). Recognizing wheat-gluten sensitivity is frequently difficult. If the doctor (or nutritionist) or the patient is even vaguely suspicious of gluten sensitivity, a special diet can be undertaken for a trial period (Pfeiffer, 2007). Unfortunately, weeks or months may be required before a marked improvement appears after wheat, gluten, rye, barley, and oats are removed from the diet (Pfeiffer). Moreover, reintroduction of these grains into the diet usually produces a relapse in months, or even hours. It is important, then to maintain a strict adherence to the diet and to be aware of the exact ingredients of all foods (Pfeiffer). Statement of the Problem The number of women in the United States diagnosed with Bipolar disorder is estimated to be approximately 12 million (National Institute of Mental Health, 2009). The primary treatment modality for women diagnosed with Bipolar Disorder is psychotropic medication (Hall, 2007). However, it is estimated that 56% percent of these women do not experience satisfactory control of their bipolar symptoms via the psychotropic modality (Hall). In addition, it is estimated that approximately 39.3% of minority women diagnosed with bipolar disorder live below the poverty level and are typically exposed to much less nutritious and healthy options than others (Hall). Furthermore, it has been 5 suggested that a diet that lacks proper nutrition or which contains food allergens, exacerbates psychiatric symptomatology (Marohn, 2008). Purpose This grant proposal is written to address the positive effects of a gluten free diet on women diagnosed with bipolar disorders as defined in the DSM -IV. The results will be recorded over the period one of year. The women’s mental health and sex/gender differences research grant will bring alternative treatment to the unique and individual needs of women in San Francisco, California. This study is based on testing of a panel including allergies of gluten, wheat, sugar and other sensitivities to food that cause bipolar symptoms or cause symptoms to be exacerbated. In America, methods that include pharmaceuticals are the respected method to treat long term issues of bipolar disorder (Hall, 2007). When patients express their concern over the negative effects of the medications given to them for bipolar disorders, doctors, and/or government officials, often ignore the evidence (Stanford, 2005). However, there is research based evidence from other countries; including the United Kingdom, Sweden, and Canada as well as evidence described by “an underground network” that individuals have benefited immensely from natural remedies to treat the symptoms of bipolar disorder (True Hope, 2008). The implementation of a gluten free diet for women diagnosed with bipolar disorders will potentially have positive outcomes on unwanted symptoms of mental illness. The gluten free diet treatment is intended to add more functionality, well being, 6 and emotional stability by removing the side effects related to the pharmaceuticals, and by diminishing the symptoms of bipolar disorder. The grant shall create an option to the negative side effects of prescription drugs that make women with bipolar disorders experience negative personality changes, including not feeling themselves, feeling drugged, emotional bluntness, diminished creativity, and reduced psychic/spiritual openness (Hall, 2007). Approval of this grant will allow women with bipolar disorder, who lack financial resources to provide themselves and their family with a gluten free diet. By utilizing this alternative treatment, it is hoped that women with symptomatic bipolar disorder can stabilize their home environment and thereby improve their children’s overall health (Kroll, 2007). It was the hope of this writer that this grant would be approved by the Women’s Mental Health and Sex/Gender Differences Research Center and that an alternative gluten-free program would be started at The Earth Circles Counseling Center in Berkeley California or/and Icarus Project and Freedom Center San Francisco, California. Delimitations of the Project This project is written to benefit women with bipolar disorder as diagnosed by using the criteria of the DSM-IV, and includes Bipolar I, Bipolar II, Major Depressive Episodes, Manic Episodes, and Mixed Episodes. The subjects must be exhibiting emotional symptoms associated with the bipolar disorder. The subjects in this study have no age, religion or race restrictions. The subject must also voluntarily agree to abstain from recreational drugs and alcohol for the course of the research project. The author of 7 this grant and project did not want to exclude any women with bipolar disorder who needed or wanted to participate in a gluten free diet. However, the majority of the subjects in the program will be selected based on a lack of financial ability to afford a gluten free diet. In addition the subjects must live in the San Francisco, California or east bay area. The subject must be naturally born female. The data for this project is based on a comprehensive review of journal articles and books. The compiling and writing of this grant proposal and chapters 1, 2, 3, and 4 were the sole task of this author. The grant was selected based on the need for programs that would help women with bipolar disorder who are unable to afford a healthy alternative gluten free diet. Definition of Terms Allergies. Abnormal immune reactions to substances that most people find harmless. There are two categories of allergens: environmental (such as pollen, dust, molds, animal dander, chemicals and cosmetics) and foods. Either category of allergens can trigger a wide range of symptoms including depression, autism, bipolar disorder, schizophrenia, migraines, seizures, arthritis, multiple sclerosis, chronic fatigue, major weight fluctuations, skin and digestive ailments, and heart palpitations. 8 Bipolar I Disorder-Diagnostic Features The essential feature of Bipolar I Disorder is a clinical course that is characterized by the occurrence of one or more Manic Episodes or Mixed Episodes. Often individuals have also had one or more Major Depressive Episodes or the presence of mania. Episodes of Substance-Induced Mood Disorder (due to direct physiological effects of a medication, other somatic treatments for depressive, a drug of abuse, or toxin exposure) or Mood Disorder Due to General Medical Condition do not count toward a diagnosis of Bipolar I disorder. In addition, the episodes are not better accounted for by Schizoaffective Disorder and are not superimposed on Schizoaffective, Schizophreniform Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified. Bipolar II Disorder- Diagnostic Features The essential feature of Bipolar II Disorder is a clinical course that is characterized by the occurrence of one or more Major Depressive Episodes accompanied by at least one Hypomanic Episode. Hypomanic Episodes should not be confused with the several days of euthymia that may follow remission of a Major Depressive Episode. Episodes of Substance Induced Mood Disorder (due to the direct effects of a medication, or other somatic treatments for depression, a drug of abuse, or toxin exposure) or Mood Disorder Due to General Medical Condition do not count toward a diagnosis of Bipolar I Disorder. In addition, the episodes are not better accounted for by Schizoaffective Disorder and are not superimposed on Schizophrenia, Schizophreniform Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified…. 9 Criteria for Major Depressive Episodes A.Five ( or more) of the following symptom have been present during the same two week period and represent a change from previous functioning: at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Note: Do not include symptoms that are clearly due to a general medical condition, or mood-incongruent delusions or hallucinations. 1. depressed mood most of the day, nearly everyday, as indicated by either subjective report (e.g., feels sad or empty) or observation made by others (e.g. appears tearful). Note: In children and adolescents, can be irritable mood. 2. markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly everyday (as indicated by either subjective account or observation made by others) 3. significant weight loss when not dieting or weight gain (e.g., a change of more than 5% of body weight in a month), or decrease or increase in appetite nearly every day. Note: In children, consider failure to make expected weight gains. 4. insomnia or hypersomnia nearly every day 5. psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings or restlessness or being slowed down) 6. fatigue or loss of energy nearly every day 7. feeling of worthlessness or excessive or inappropriate guilt ( which may be delusional) nearly every day (not merely self-reproach or guilt about being sick) 10 8. diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others) 9. recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or specific plan for committing suicide A. The symptoms do not meet criteria for a Mixed Episode. B. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. C. The symptoms are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition (e.g., hypothyroidism). D. The symptoms are not better accounted for by bereavement, i.e., after the loss of a loved one, the symptoms persist for longer than two months or are characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, psychotic symptoms, or psychomotor retardation. Criteria for Manic Episode A. A distinct period of abnormally and persistently elevated, expansive , or irritable mood, lasting at least a week (or any duration if hospitalization is necessary). B. During the period of mood disturbance, three (or more) of the following symptoms have persisted (four if the mood is only irritable) and been present to a significant degree: 11 1. inflated self esteem or grandiosity 2. decreased need for sleep (e.g., feels rested after only three hours of sleep) 3. more talkative than usual or pressure to keep talking 4. flight of ideas or subjective experience that thoughts are racing 5. distractibility (i.e., attention too easily drawn to unimportant or irrelevant external stimuli) 6. increase in goal-directed activity (either socially, at work or school, or sexually) or psychomotor agitation 7. excessive involvement in pleasurable activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) C. The symptoms don’t meet the criteria for a Mixed Episode. D. The mood disturbance is sufficiently severe to cause a marked impairment in occupational functioning or in unusual social activities or relationships with others, or to necessitate hospitalization to prevent harm form self or others, or there are psychotic features. E. The symptoms are not due to the direct physiological effects of a substance (e.g., hyperthyroidism). Note: Manic-like episodes that are clearly caused by somatic antidepressant treatment (e.g., medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar I Disorder. 12 Criteria for Mixed Episode A. The criteria are met both for a Manic Episode and Major Depressive Episode (except for duration) nearly every day during at least a 1 week period. B. The mood disturbance is sufficiently severe to cause marked impairment in occupational functioning or in usual social activities or relationships with others, or to necessitate hospitalization to prevent harm to self or others, or there are psychotic features. C. The symptoms are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication, or other treatment) or general medical condition (e.g., by hyperthyroidism). Criteria for Hypomanic Episode A. A distinct period or persistently elevated, expansive, or irritable mood, lasting throughout at least a 4 days, that is clearly different form usual nondepressed mood. B. During the period of the mood disturbance, three (or more) of the following symptoms have persisted (four if the mood is only irritable) and have been present to a significant degree. 1. inflated self-esteem or grandiosity 2. decreased need for sleep (e.g., feels rested after 3 hours of sleep) 3. more talkative than usual or pressure to keep talking 4. flight of ideas or subjective experience that thoughts are racing 13 5. distractibility (i.e., attention to easily drawn to unimportant or irrelevant external stimuli) 6. increase in goal-directed activity (either socially, at work or school, or sexually) or psychomotor agitation 7. excessive involvement in pleasurable activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments. C. The episode is associated with an unequivocal change in functioning that is uncharacteristic of the person when not symptomatic. D. The disturbance in the mood and the change in functioning are observable by others. E. The episode is not severe enough to cause marked impairment in the social or occupational functioning, or to necessitate hospitalization, and there are no psychotic features. F. The symptoms are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication, or other treatment) or general medical condition (e.g., hyperthyroidism). Note: Hypomanic like episodes that are clearly caused by somatic antidepressant treatment (e.g., medication, electroconvulsive therapy, and light therapy) should not count toward a diagnosis of Bipolar II Disorder. 14 Gluten. Gluten is a protein found in wheat, barley, rye, oats and other cereals grains, and which is added to many commercial foods. Gluten is difficult to digest and many people develop an intolerance to it, which means the body regards it as a foreign substance and the immune system launches an immune reaction against it. Gluten Intolerance. Is a condition that requires adherence to a gluten- free diet but does not rise to the level of an autoimmune disease. Food intolerances occur when the body is incapable of metabolizing certain foods, typically because it lacks certain enzymes necessary to break down particular food components. Individuals with gluten intolerance often have the same overt symptoms as those with Celiac Disease (CD), but they test negative for celiac disease by blood work and endoscopy. They learn through trial and error that gluten is a cause for their uncomfortable symptoms and, once they adopt a gluten-free diet, live an otherwise normal healthy life. Nambudripads Allergy Elimination Techniques. Also known as NAET, are non-invasive, drug free, natural solution to eliminate allergies of all types and intensities using a blend of selective energy balancing, testing and treatment procedures from acupuncture/acupressure, allopathy, chiropractic, nutritional, 15 and kinesiological disciples of medicine. Orthomolecular ecologic psychiatrists firmly believe that foods, chemicals and inhalants in the environment affect human behavior. R21 Mechanism. R21 mechanism is intended to encourage new exploratory and developmental research projects in biomedical informatics, biomedical information, and health sciences library and information sciences. Theses studies may involve considerable risk but may lead to a breakthrough in particular areas, or to the development of novel techniques, agents, methodologies, models, or applications that could have major impact on a felid in biomedical, behavioral, or clinical research. Toximolecular Psychiatrists. Those who use drugs or synthetic substances not normally found in the human body. Organization of the remainder of the project Chapter 2 will review the literature related to the following topics: specific gender needs for women with bipolar disorder; alternative treatment to psychiatric drugs; removing the use of psychiatric medications, research studies, benefits of gluten free diet for women with bipolar disorder, bipolar disorder exacerbations, symptoms of gluten allergy and summary. 16 Chapter 3 will describe the methods used to apply for the grant, a grant description model, supporting research, program services, program staffing, program evaluation and program continuation. Chapter 4 will describe chapter conclusions, summary, and recommendations. Chapter 5 will describe conclusions reached and give resources for alternative healing, resources for gluten free programs, informative websites. 17 Chapter 2 REVIEW OF THE LITERATURE The average American consumes one pound of chemical food additives per year (Reiman, 2005). Speaking on the floor of the U.S Senate, Sen. Gaylord Nelson indicated people are finally waking up to the fact that the average American daily diet is substantially adulterated with unnecessary and poisonous chemicals and frequently filled with neutral, nonnutritious substances. Nelson also declared, people are being chemically medicated against their will and cheated of food value by low nutrition food standards (Reiman). Beatrice Hunter (2006) has authored The Mirage of Safety, a catalog of the possible dangers that lurk in the foods we eat. The Mirage of Safety, is a description of how the Food and Drug Administration, through a combination of lax enforcement and uncritical acceptance of the results of the food industry’s own “scientific” research has allowed a situation to exist in which the American public is the real guinea pig for nearly 3,000 food additives (Hunter). As a result, American citizens are subjected to chemicals strongly suspected of producing cancer, mental illness, gallbladder ailments and severe allergies (Reiman). Americans also are exposed to other chemicals that inhibit “mammalian cell growth” and may adversely affect the rate of DNA, RNA, and protein synthesis and to similar chemicals that are capable of crossing the placental barrier between mother and fetus and are suspected causes of birth defects and congenital disease (Reiman). During the 1980’s, American farmers used about eight million pounds of the active ingredients in pesticides each year (Reiman, 2005). In 2003 farmers reported using 18 one billion pounds of chemical on crops each year (New York Times). Dr. Landrigan of the Mount Sinia School of Medicine, writing in the 2002 issue of the American Journal of Public Health, points to recent data from the US Environmental Protection Agency (EPA) showing that infants and young children are permitted to have dietary exposures to potentially carcinogenic and neurotoxin pesticides that exceed published standards by a factor of more than 1000 (EPA, 2004). If these unnatural and dangerous chemicals are in the food Americans consume, the effects to their neurological state must also be considered as part of the underlying causes of mental disorders that have also steadily risen over the years (Reiman). Landrigan (2002) also estimates three to 4 million American preschool children have dangerously elevated blood lead levels, which could result in long- term neuropsychological impairment. According to the Diagnostic and Statistical Manual of Mental Disorders (2007), 4 out of 10 leading causes of disability in the US and other developed countries are mental disorders. A recent report on mental health by the Surgeon General (2008) indicated bipolar disorder ranked first among the top ten causes of worldwide disability. Mostly, bipolar disorder goes undiagnosed and women visit physicians seeking other explanations for their difficulties (Jonas and Brody). Specific Gender Needs for Women with Bipolar Disorder A gluten free program has been utilized at San Quentin State Prison for four consecutive years. However, even with the success of the gluten free program at San Quentin, it has only been implemented only on the male population (Hortiz, 2007). It is 19 imperative the female population diagnosed with bipolar disorder be included if such research and case studies are this greatly beneficial. A growing number of psychiatrists find reactions to foods and various chemicals to be common in different forms of degenerative disease, and manifest in mental and/ or physical symptoms (Philpott & Kalita 2000). This suggests that the area of adverse reactions to food and additives is rapidly expanding and becoming legitimized by a scientific base (Edelman, 2003). Most antidepressants and other prescription drugs cause severe side effects, which usually discourage patients from taking their medications (Lakhan & Vieira 2008). However, this information is being ignored by both the medical and pharmaceutical communities (Lakhan & Vieira, 2008). England and Abery (2001) stated that, over the past 20 years, there has been a change in family patterns, to include increased incidents of family violence and mental illness, and a drastic increase in the number of women and children living in poverty. The estimates of the percentage of marriages that will be dissolved and the percentage of women and children that will spend some time in a single-parent family have surpassed 50% of the population (Heaton & Jacobson, 2004). A household that deals with bipolar disorder has a massive affect on the whole family unit, but especially the children. A major review article in the Australian and New Zealand Journal of Psychiatry, discussed special considerations for women who have bipolar disorder. According to this article gender differences differentiate diagnosis and treatment of bipolar disorder intended for men and women (Barnes & Mitchell 2005). A woman’s metabolism is controlled by 20 hormones and these powerful chemicals play an important role in understanding bipolar disorder in women (Barnes & Mitchell). The following are highlights from Schizophrenia and Bipolar Education Day at Stanford University on August 4, 2005, Bipolar I is equally prevalent among men and women; Bipolar II (characterized by milder, ‘hypomanic’ episodes, but a greater burden of depression) is more commonly reported in women. Women with bipolar disorder tend to report more episodes of depression than men. Women also experience more ‘mixed’ episodes (episodes which have simultaneous features of both mania and depression. Women are almost three times as likely as men to have a comorbid diagnosis. Two of the most common comorbid disorders for women with bipolar disorder were alcoholism and anxiety disorder. These combinations can trigger more frequent episodes. Women with bipolar disorder are more likely to be rapid cyclers (experience four or more episodes a year) than men (Barnes & Mitchell, 2007). Proposed explanations for this include effects of gonadal steroids (estrogen or testosterone), hypothyroidism (more common in women), and greater use of antidepressant medication in women, which has been reported to cause episodes of mania in people with bipolar disorder. Also relative are the effects that female hormones (menstrual cycle) can have on women with bipolar disorder. Menstrual cycle hormones (fluctuation in estrogen and progesterone, which can act on the activity of neurotransmitters serotonin, noradrenalin, and GABA) may exacerbate bipolar symptoms in women. Two of the studies utilized at Schizophrenia and Bipolar Education at Stanford University reported that 65% of women with bipolar disorder reported worse mood symptoms during their menstrual cycle (Barnes & 21 Mitchell). Pregnancy can also bring hormonal changes that can exacerbate symptoms for women with bipolar disorder. Pregnancy represents a period of increased risk for women with bipolar disorder. In one study, half of the women with bipolar disorder reported a worsening of their symptoms during pregnancy (Barnes & Mitchell, 2007). The post partum period is also recognized in this literature as a time of highly increased risk for an affective and/or psychotic episode. Relapse rates for women with bipolar disorders within 3-6 months of childbirth are reported to be as high as 67-82% (Barnes & Mitchell). Moreover, the risk of psychosis increases from 10-20% in women with bipolar disorder during the post partum period (Barnes & Mitchell). Dr.Terence Ketter spoke about bipolar disorder at the Stanford University Schizophrenia and Bipolar Education Day August 4, 2005, and acknowledged women with bipolar disorder in the post-partum period are at highly increased risk for experiencing a depressive episode. He also indicated “although the books won’t tell you these things… in my clinical experience, women say it is the worst episode they have ever had”. Women who become pregnant while taking prescription pharmaceuticals can risk the lives and health of their unborn baby (Barnes & Mitchell, 2005). However, long term studies have not been conducted to investigate the use of pharmaceuticals in pregnancy. The results of such studies would be of greatest importance with respect to the first trimester of a women’s pregnancy when the fetus’ major organs are being formed. Studies of the effects of antipsychotics on women who breast feed have been 22 inclusive. Therefore, it seems safer to insure the healthiest baby by using alternative and natural treatments that are not harmful to the mother or the fetus. The issues described above are a few of the special needs that are important to the research of gender differences and are specific to this grant proposal for women with bipolar disorder. Alternatives Treatments to Psychiatric Medications There exist many different alternative treatments including vitamins, diets, herbs and therapies that can be utilized when treating bipolar disorder (Marohn, 2005). The True Hope treatment program uses a vitamin supplemental method (Marohn). Since 1966, scientific researchers and doctors at True Hope treatment program and other clinical practices have been studying the effects of nutrients, diets and herbs for bipolar disorder (Marohn). Dr. Bonnie Kaplan, a behavioral research scientist and the principle researcher on several of True Hopes studies indicated the normalization of mentally ill patients by means of nutrient supplementation would be the most significant breakthrough in the field of mental illness (True Hope, 2005). This women’s mental health and sex/gender differences research grant will establish respectful communication with doctors and those women with bipolar disorder who have an aversion to heavy sedation of psychotropic medications and or allergies. Heavy prescription sedation is currently being encouraged by the medical community though other treatments exist (Hall, 2007). 23 Effective therapeutic services exist that use a list of pharmaceutics and behavior therapy (Stegler, 2004). Natural remedies or the application of a healthy diet, including replacement of essential vitamins that contribute to the causes and symptoms of bipolar disorder have also been proven effective (Kroll, 2007). However, these alternatives are not included as options for impoverished women who face multiple barriers to access alternative services and could benefit from natural medicine and allergy interventions (Kroll). In the United States alone, 30 million (1 in 10) people are now taking Prozac, and the World Health Organization (WHO) predicts that by year 2020 depression will be the single leading cause of death around the globe (Hall, 2007). It is important that the challenge to support women with bipolar disorder from lower income levels be addressed, in order for them to become healthier individuals better able contribute to society (Hall). Many times alternative methods are not discussed with women who have bipolar disorder who may wish to be introduced to other available treatments (Stengler, 2004). Because psychiatric medications are a multi-billion dollar industry like big oil and military spending, companies have incentives and means to cover facts about their products (Hall, 2007). Companies actively suppress accurate assessments of drug risks, mislead patients about how objective a mental disorder diagnosis is, promote a false understanding of how psychiatric drugs really work, keep research into alternative approaches unfunded and unpublicized, and obscure the role of trauma and oppression in mental suffering (Hall). Individual approaches must be made to assist women with 24 bipolar disorder one method does not work for all women (Null, 2003). Many women diagnosed with bipolar disorder complain about psychiatric medication side effects, yet this is ignored within the medical community (Hall). With in the mental health system, it has been “one size fits all” (Pfeiffer, 2007). Regardless of the human cost, scandals are growing, and the fraud and corruption surrounding some psychiatric drugs are reaching tobacco-industry proportions (Brody and Roper, 2003). Since the 1950’s, the treatment of mental illness with drugs has become the major therapeutic tool of psychiatrists the world over (Pfeiffer, 2005). The first antipsychotic drug, Reserpine, was introduced into psychiatric practice in 1952, shortly followed by chlorpromazine (Thorazine) in 1954 (Pfeiffer). Drugs such as major tranquilizers should only be considered as temporary crutches, to be used until the biochemical imbalances are slowly corrected by nutrient therapy (Hall). Giving nutrients to neurological pathways could have long lasting positive results that would lead to the removal for the need of sedative drugging (Philpott & Kalita, 2000). A problem which has been overlooked in the treatment of mental disorders until recently is the discomfort to the patient resulting from side effects of some psychotherapeutic drugs (Hall, 2007). Patients taking psychiatric medications may find themselves unable to steady their hands (Hall). Other discomforts may include involuntary facial muscle twitches and suicidal tendencies (Hall). Replenishing the body nutrients is much different from psychiatric medications (Pfeiffer, 2007). The nutritional approach to disease provides opportunities for objective measurement, the necessary yardsticks for calculating the degree of impairment of the 25 body, and the slow gradual improvement, which occurs as the nutrients speed up normal biochemical processes (Pfeiffer, 2007). The reason nutritional deficiencies are widespread in society is because we consume monumental quantities of refined food and many people suffer from unidentified food allergies (Reiman, 2005). Therefore, it can be extremely beneficial to women diagnosed with bipolar disorder to follow a gluten free diet. Gluten allergies can cause women with bipolar disorder to become more symptomatic (Pfeiffer). Allergy testing and financial support for gluten free groceries will be available in San Francisco, California at the Icarus Project and Freedom Center and/or Earth Circles Counseling Center. These supports will assist women with bipolar disorder to meet the expense of the significant cost associated with assessing allergies and purchasing gluten free diet products. In addition, counseling will be available during the weaning off psychiatric medications. As described earlier, abstaining from recreational drugs and alcohol is a prerequisite to be admitted into this gluten free grocery program. Significant improvement to the overall health of women with bipolar disorder and emotional stability during the course program is most likely to occur in the absence of recreational drug use. Research suggests that, women with bipolar disorder, who use psychoactive drug substances, are at increased risk for social stigma and negative consequences, including the risk suicide or incarceration (Snow, 2008). The outcomes of treatment for women with bipolar disorder will improve when both bipolar disorder and substance abuse are addressed together (Snow). Snow, also found that patients with bipolar disorders who develop substance abuse tend to have an earlier onset of bipolar disorder, than those who 26 develop substance abuse after the onset of bipolar disorder. Individuals who have both bipolar disorder and substance abuse, regardless of which came first, make more suicide attempts than do those with bipolar disorder without any substance abuse (Snow). The author of this grant does not wish to subject the participants to any increased risk of suicidal behavior. Any additional complications directly affecting women with bipolar disorder participating in the gluten free grocery study program shall be responsibly reduced. Women with bipolar disorder can react negatively to the use of recreational drug and food allergies (Stengler, 2004). Some women can have reactions to blood sugar or caffeine that gets mistaken for psychosis or mental disorders (Hall, 2007). These types of reactions in the body can threaten health, stability and sleep for people (Hall). Nutrition can play a huge role in mental stability and better health (Pfeiffer, 2005). Exploring food allergies such as wheat, gluten and milk can bring more vital nutrients back to the mind and body (Hall). Toximolecular psychiatrists can sometimes manage to control psychiatric symptoms of bipolar disorder (Philpott & Kalita, 2000). The underlying disease process responsible for the symptoms in the first place often remains unchecked (Philpott & Kalita). Many patients on drugs have to pay a high price for their symptomatic relief by running the statistically high risk of becoming permanently incarcerated in their chemical straightjackets (Philpott & Kalita). Dr. Robert Okin, former Commissioner of Mental Health in Massachusetts, said, “Many patients who had been institutionalized for years now find themselves living in low cost rooming houses, rocking in front of TV sets, and 27 wandering in the streets”. Many of these patients are being readmitted to mental hospitals over and over (Okin, 2007). At Sutter Center for Psychiatry in Sacramento, California a meeting is held for people with bipolar disorder and those who support them. Meetings are once a month on Thursday in the evening. During these meetings, many women with bipolar disorder discuss openly their continuous readmittadance into the hospital despite their use of six to 10 pharmaceutical drugs prescribed by their doctors. Research Studies According to Lakham & Vieira (2008) many of the alternative studies including gluten free diets and vitamin therapy for bipolar research were conducted in the 1970’s and 1980’s, but were shut down due to underfunding. Nutritional therapies have now become a long forgotten method of treatment, because they were of no interest to pharmaceutical companies that could not fund patents or own them (Lakhan & Vieira). Instead, the companies spent money investigating synthetics drugs they could patent and sell; these drugs, however, cause severe adverse side effects (Lakhan & Vieira). Other recent studies have indicated that gluten allergies may be responsible for many cases of “bipolar disorder” and “schizophrenia” (Pfeiffer, 2005). One of the earliest observations of the relationship between cereal grains and mental illness was reported by Dr. Lauretta Bender in 1953, when she noted that children with schizophrenia and bipolar disorder were extraordinarily subject to gluten free allergy. In the same year a study by Graff and Handford published data stating that four of 37 adult males with mental disorders admitted to the Institute of Pennsylvania Hospital, Philadelphia had a 28 history of gluten and wheat allergies in childhood (Graff & Handford, 1961). Therefore, there are serious benefits to the health of women with children to use and maintain a gluten free lifestyle (Philpott & Kalita, 2000). According to Philpott & Kalita (2000), allergies to wheat and gluten stop the body from processing the correct amount of protein and vitamins it needs to stay healthy. This condition causes mental reactions that may closely mimic types of mental disorders. A person cannot be deficient, toxic, or addicted to any food or chemical without suffering the consequences of progression of the disease process onto a chronic degenerative illness of some type”. Study One The importance of considering gluten sensitivity is well demonstrated in a study by Dr. John Dohan (Casper, 2004). He randomly assigned all men admitted to a locked psychiatric ward in a Veterans Administration Hospital in Coatesville, Pennsylvania, to either a diet containing no milk or (wheat or gluten) cereals of a diet that was relatively high in cereals. (Milk was eliminated from the diet because some people do not benefit when only glutens are removed.) All other treatment remained as it had been. Midway through the experiment 62 percent of the group on no milk and cereal were released to a “full privileges” ward, while only 36 percent of those patients receiving a diet including cereal were able to leave the locked ward. When the wheat gluten was secretly placed back into the diet, the improved patients relapsed. Therefore, the study results suggested that wheat- gluten sensitivity should be considered in the pathogenesis of the “bipolar and 29 schizophrenics,” and once diagnosis has been made, patients should understand and use a diet free of any milk and gluten (Fabrega, 2008). Study Two A National Institute of Mental Health controlled study, of 34 women with relatively normal estrogen, found non gluten intake improved mood 80% relieving earlymorning waking, loss of enjoyment, sadness and irritability (Schimdit, 2000). Menstrual cycle effects include irritability, sadness, anxiety, insecurity, lethargy, tears, fatigue, impatience, restlessness and tension. Nonetheless, suicide admissions increase just before, and during menses. Affective psychosis is sometimes tied to menstrual cycle, and may respond to appropriate hormones, a gluten free diet, and/or relevant nutrients in use with other mood stabilizing therapy (Glick, Stewart, 2008). Study Three In Italy children are tested for wheat and gluten sensitivity by age seven (Celiac.com). In the year 2000, a community based “CD-Watch” follow up program was designed by the local Health Authority of the Brescia Province in Northern Italy. The hope for the CD-Watch program was to increase awareness of gluten allergies and celiac disease and to standardize diagnostic criteria for gluten intolerance and celiac disease among health care professionals. Beginning in January 2003, all patients that reside in the Province of Brescia have been enrolled in an ongoing CD-watch including gluten allergies and follow up program. As a means of support the Italian government gives 30 patients a bonus to subsidize their gluten-free diet, and all the patients are required to contact the Local Health Authority every year to renew their bonus. Furthermore, the CD-Watch program requires all patients to have their blood serum tested once a year for detection of certain antibodies. Testing for the antibodies begins 12-16 months after a diagnosis. The testing is free of charge to the patients and they can choose any laboratory they like. Results from the antibodies testing get reported to the Local Health Authority, and it is a requirement to continue to receive subsidization, although patients continue to receive subsidization regardless of their antibodies results. Benefits of Gluten Free Diet for Women with Bipolar Disorder Everyone can benefit from optimum nutrition. Moreover, food allergies can be detrimental to mental and physical health (Frazier, 2009). Not everyone can digest wheat, rye, and other cereal grains (Pfeiffer, 2007). Allergies to wheat and gluten cause food to go into the gut undigested (Pfeiffer). Furthermore, alcohol and other recreational drug use can increase depression in women with bipolar disorder (Snow, 2008). Therefore, removing alcohol, in conjunction with a gluten free diet would be of most benefit. Variables that Exacerbate Bipolar Disorder A number of variables can exacerbate or contribute to bipolar disorder. These contributing variables can include genetic vulnerability, stress, chemical toxicity, heavy mental toxicity, food allergies, intestinal dysbiosis, sensitivity to food additives, nutritional deficiencies or imbalances, neurotransmitter deficiencies or dysfunction, 31 hormonal imbalances, hypoglycemia, structural factors, medical conditions, medications, stimulants, lack of sleep, lack of exercise, lack of light, energy imbalances, and psychospiritual issues (Marohn, 2005). The Gluten Free Grocery Program wants to commit to help reduce/remove the symptoms that contribute to exacerbating or facilitating bipolar disorder by eliminating gluten intake upon foods that contain gluten. There are many misconceptions about foods that may or may not contain gluten. The ingredients in products are often hidden within other names. Therefore, the individual must do extensive research to avoid foods that contain gluten. Grains that contain gluten include wheat, spelt, kamut, teff, triticale, semonlina, rye, oats, and barley (Marohn, 2005). Other foods/ substances that often contain gluten include vinegar, delicatessen meats, bouillon, dextrin, caramel color, food starch, hydrolyzed plant or vegetable protein, monosodium glutamate (MSG), malt, and rice syrup, and natural and artificial flavorings (Marohn). There are many other foods and substances that may contain gluten, including chewing gum, condiments, confectioner’s sugar, envelope glue, frozen french fries, ice cream, medications, salad dressings, tomato paste, tuna fish, and vitamins/mineral supplements (Marohn). Symptoms of Gluten Allergies There are numerous potential symptoms of allergic reaction to gluten including the following anemia (low hemoglobin), autoimmune disorders such as rheumatoid arthritis and lupus, behavioral changes (depression, irritability, failure to concentrate), bloating and gas or abdominal pain distention, bone or joint pain, changes in appetite, chronic diarrhea, colitis, collagen vascular disease, constipation, dermatitis herpetiformis 32 (burning, itchy, and blistering skin rash), delayed growth in children and delayed onset of puberty, dizziness, easy bruising, failure to thrive in infancy, fatigue and lethargy, fibromyalgia, hair loss, headaches, hypoglycemia (low blood sugar), hyposplenism, increased risk of infections, infertility and miscarriage, iron deficiency, irregular or speedy heartbeat, lactose intolerance, liver disease, lupus, lymphoma (cancer of lymph glands), malnutrition, missed menstrual periods, mental fogginess, muscle cramps, nausea and or vomiting, neurology problems (including schizophrenia, bipolar disorder, ataxia, and epilepsy), nosebleeds, osteoporosis or osteopenia, pale, foul-smelling, bulky, and/ or fatty stools that float, pale skin, seizures, short stature, shortness or breath, Sjogren’s syndrome, intestinal cancers, thyroid disease (hyper- or hypothyroidism), tingling or numbness in the hands and feet, tooth discoloration or dental enamel defects/loss, type 1 diabetes, ulcers inside the mouth (aphthlous ulcers), vitamin or mineral deficiency, and weight and loss/gain (Philpot & Kalita, 2000). Summary There are many factors to be considered and examined when starting a gluten free diet and discontinuing psychiatric medications. Many women who are diagnosed with bipolar disorders experience their first psychotic episode after taking the drugs (Hall, 2007)). Evidence shows that it is not impossible or harmful to consider the alternative to the heavy sedation that occurs when psychiatric drugs are used (Hall). In addition, there are no side effects of using a healthy gluten free diet. This alternative gluten- free diet is especially appealing to those who have had to endure the harshness of the prescribed 33 psychotropic drugs or who stop taking them due to side effects. Every woman with bipolar disorder is different. Alternative treatments for women with bipolar disorder who do not receive significant benefit or relief from psychiatric drugs are a necessary endeavor. Psychiatric drugs do not treat the core problems or address the needs of the individual as a person (Kilbourne, 2007). Women who are diagnosed with bipolar disorders deserve to be treated fairly by the government and the medical community alike (Hall, 2007). A woman with bipolar disorder needs to be allowed to exercise her options for treatment. A doctor not respecting the choice or decision of a patient wanting to remove psychiatric drugs is absurd and should not be tolerated (Hall). It is unethical for the medical community to make decisions for women who have been diagnosed with bipolar disorders without full disclosure of all available treatments. Bipolar disorder symptoms can be subjective and there is not a scientific blood test to confirm diagnosis, therefore, many women are misdiagnosed (Bourre, 2007). Hence, the requests of the women diagnosed with bipolar disorder must be respected, so that she can have sufficient support to resume the most beneficial existence (Edelman, 2003). 34 Chapter 3 METHODOLOGY Request for Application This grant is designed to provide an opportunity for patients diagnosed with bipolar disorder to have access to a gluten free diet as an alternative to traditional psychotropic medication. In addition, the grant seeks to reduce, diminish, and/or modify the medication-based treatment and to offer a gluten free alternative for those women suffering from serious side effects from psychotropic medications. The National Institute of Health (NIH) seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research, by using the R21 mechanism. The R21 mechanism is intended to encourage new exploratory and developmental research projects. The Department of Health Services (DHS), including National Institutes of Health (NIH) and National Institute of Mental Health (NIMH), are the organizations that offer The Women’s Mental Health and Sex/Gender Differences Research Grant. Notification of this grant is made through www.grants.gov. or by using CSUS, SMARTS output. Description of a Model The model description depicts the nature, goals and the requirements of the Gluten Free Grocery Program. This writer also had to make sure to include and cite the sources that were used in preparing this section of the grant. The Gluten Free Grocery Program wishes to achieve saturation in qualitative research and identify all themes to 35 reduce the symptoms related to bipolar disorder. In addition this grant wished to accomplish testing and the complete removal of gluten allergies. In addition, a individual schedule for each participant to wean them off psychotropic medication will ensue. These above described activities will take place to provide the highest level of functionality for women diagnosed with bipolar disorder. There is no matching contribution at stake. Because the nature and the scope of proposed research will vary from application to application, it is anticipated that size and duration of each award will also vary. Costs requested by consortium participants are not included in the direct cost limitation. Finally, this writer had to locate where the Gluten Free Grocery Program would be used in the San Francisco, California region. To her knowledge and research at the current time, a program is not being utilized. In order to complete this section, this writer used literature that was researched by various authors, journals and periodicals. She also used information gathered by self research on a gluten free diet for over two years along with another volunteer subject (Brooke Nelson) a woman with bipolar disorder at Sutter Center for Psychiatry, to collect relevant information to create the conditions for a grantbased gluten free grocery program. The National Association of Mental Illness and several other bipolar websites dedicated to bipolar disorder issues were used to validate the severe need of alternatives choices to current treatments. Program Services This section of the program services includes descriptions of several different elements. It begins with a project goal, description of direct activities and objectives for 36 women with bipolar disorder at the Icarus Project and Freedom Center where the Gluten Free Grocery Program (GFGP) to be administrated. This program will include the support in the removal of all participants’ psychiatric medications, testing of gluten allergies, screening of street drugs/ alcohol, and the delivery of gluten free groceries. This programs goal is to remove/ reduce the symptoms related to bipolar disorder and to increase individual levels of functionality. Program Staffing The staffing of the Gluten Free Grocery Program will include the project coordinator who will be responsible for the administration, management of the budget, development and implementation of the program evaluation. The program coordinator will also recruit from Icarus Project and Freedom Center and Earth Circles Counseling Center. The on staff doctor will assist with the safe removal of psychotropic medication and monitoring. A nurse will be utilized as support to the participants. A nutritionist will ensure the removal of gluten from the participant’s diet. The driver will pick up and deliver groceries to the participants as well as return data forms Evaluations This section describes methods that will be used for evaluating the effectiveness of the program. It also describes how the evaluation will address the local issues and concerns of the Gluten Free Grocery Program and its target design. Organizational Structure 37 The organization of the project will include the direct support of The Icarus Freedom Project Group and The Earth Circles Counseling Center. These centers will help to provide counseling and support for the participants participating in the Gluten Free Grocery Program. The total project period for an application submitted in response to this funding opportunity may not exceed two years. The direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Once the financial commitment and grant approval is complete, the Icarus Project and the Freedom Center and Earth Circles Counseling Center will assist to recruit and address those chosen participants to receive the gluten free grocery benefits. Participants, family members and any personnel involved in the program will be made aware of the risks (symptoms and issues) concerning the reduction of or weaning off psychiatric medications. Summary The Gluten Free Grocery Program is designed to develop individual functionality by testing for allergies, and funding the cost of a gluten free diet that will facilitate women with bipolar disorder to discontinue dangerous psychiatric medications. The grant divides into nine parts, the problem statement, target population, goals and objectives, literature review, methods, strategies and program design, evaluation, organizational structure and the budget. 38 Chapter 4 CONCLUSIONS The review of the literature substantiates the need for a Gluten Free Grocery Program in the San Francisco, California area. According to Hall (2007), statistics have shown that many women with bipolar disorder are interested in alterative treatments to avoid the severe side effects of psychiatric drugs. To assist women with successful adjustment, this writer recommends the program be implemented with assistance of The Icarus Project and Freedom Center and the Earth Circles Counseling Center. This project intention is to provide funding for a Gluten Free Grocery Program in collaboration with the Icarus Project and Freedom Center and the Earth Circles Counseling Center. The Women’s Mental Health and Sex/Gender Differences Research grant will utilize key techniques such as allergy testing and nutrition diet therapy, to reduce the symptoms those women who have been diagnosed with bipolar disorder experience. This reduction or absence of symptoms can guide the women who participate in this program, to experience more functionality and life vitality. This reduction in symptoms can lead the participants in this program with improved functionality to gain better employment and emotional stability. In addition, those women diagnosed with bipolar disorder that stop taking psychiatric medications due to the harsh side effects, could remain on a gluten free diet with out risk of severe side effects. This is highly beneficial research because a continuous course of therapy would enable participants to maintain a healthy form of advantageous treatment. 39 Summary The purpose of this project is to produce a grant proposal for women with bipolar disorder who would like to volunteer for an alternative treatment of bipolar disorder. This writer realizes the need for such programs after herself using many different psychiatric drugs to treat bipolar disorder. Over the course of several years of experiencing severe allergic reactions, as well as negative attitudes from doctors opposing medication alternatives the pursuit of an alternative treatment seemed warranted. Medical professionals made the author feel that there were no other choices and they never offered any alternatives to psychiatric medications. In addition, the author was exposed to many women with bipolar disorder, who shared their personal experiences of wanting to undertake alternatives to psychiatric drugs. Several other authors including Hall (2007), Marohn (2007), Guyol (2006), and Null (2003) agree that alternative treatments to the use of psychotropic medications are desirable to treat bipolar disorder. Recommendations It is imperative that women with bipolar disorder be tested for gluten allergies as early as possible. Other recommendations are the following: 1) Full disclosure of the ingredients in food on the labels, to agreed upon by the Food and Drug Administration. The American government has to be required to create a standard healthy diet system without the use of artificial ingredients and pesticides. Corporations should be completely regulated by the consumers. Corporations must not be able to earn soaring profits by using artificial food ingredients and allowing unnecessary chemicals to 40 be added in the food. Producing a healthy source of available food options for Americans to have balanced diets should be mandatory. 2) Awareness of food ingredients/ additives Adequate diagnosis, allergy testing, improvement of the diet, and treatment with specific nutrients is the first step toward a more effective and tolerable treatment of individuals diagnosed with bipolar disorder. 3) Educate physicians, psychiatrists and psychologists regarding alternative treatment for bipolar disorders. 4) Additional benefits that may facilitate those women diagnosed with bipolar disorder reduce psychotropic medications and access alternative resource include requiring vending machines to include gluten free alternatives, 75% of television commercials to show food choices with natural ingredients, 30% of billboards to include unaltered natural healthy foods, making alternative medicine disclosure required by law as an option to psychotropic drugs, remove, drug advertising in the public, concentrate on better relations between patients and doctors, provide more education to the hospital/clinic staff, limit large discrepancies between scientific understanding and clinical use of medications, adequately diagnose gluten allergies, utilize clinical evaluation and dietary counseling and provide free mental health care and allergy testing to those women with bipolar disorder that need or want it. 41 Chapter 5 RESOURCES FOR NATURAL ALTERNATIVES FOR HEALING Referral Organizations American Association of Naturopathic Physicians 4435 Wisconsin Avenue, NW Suite 403 Washington, DC 20026 (202) 237-8150 (866) 538-2267 toll free www.naturalpathic.org with search referral system In addition to basic medical sciences and convention diagnosis, naturopathic physicians (N.D.s) are the highest trained practitioners in the broad scope of alternative medicine. Alternative medicine includes therapeutic nutrition, botanical medicine, homeopathy, natural childbirth, classical Chinese medicine, hydrotherapy, naturopathic manipulative therapy, pharmacology, and minor surgery. American College for the Advancement of Medicine (ACAM) 23121 Verdugo Drive, Suite 204 Laguna Hills, CA 92653 (949) 583-7666 (800) 532-3688 toll free www.acam.org with search/referral system 42 ACAM is the largest and oldest nonprofit medical society dedicated to educating physicians and other health care professionals on the latest findings and emerging procedures in preventive/nutritional (alternative) medicine. EEG institute 22020 Clarendon Street, #305 Woodland Hills, CA 91367 (818) 373-1334 www.eeginfo.com with search/referral system The EEG Institute is the clinic and research center of the Brian Othmer Foundation, a nonprofit agency dedicated to research, education and clinical services in neurofeedback. National Center for Homeopathy 801 North Fairfax Street, Suite 306 Alexandria, VA 22314 (703) 548-7790 www.homeopathic.org with search/referral system NCH is the leading open-membership organization supporting and promoting homeopathy in the U.S. 43 Safe Harbor 787 West Woodbury Road, #2 Altadena, Ca 91001 (626) 791-7868 www.alternativementalhealth.com with search/referral system A nonprofit agency educating the public, medical practitioners, and the government about safe alternative mental health treatments. Seminars meet the requirements of the Accreditation Council for Continuing Medical Education. Well Mind Association of Greater Washington P.O Box 201 Kensington, MD 20895 (301) 774-6617 Well Mind Association of Greater Washington is a nonprofit clearinghouse for alternative mental health informational and referrals. Resources: Celiac Disease, Gluten Free Programs and Specialists University of Chicago Celiac Disease program http://www.uschospitals.edu/specialites/celiac/index.php Dr. Stefanno Guandalini www.celiacdisease.net Director: Michelle Merlin-Rogovin 773-702-7593 44 Children’s Digestive Health Center Dr. Joseph Levy, M.D. 3959 Broadway BHN-726 New York, NY 10032 212-305-5693 University of Maryland Center for Celiac Research Dr. Alesio Fasano, M.D. Director Pam King 20 Penn Street, Room S303B Baltimore, MD 21201 410-328-6749 or 1800-492-5538 www.celiachealth.org or www.celiaccenter.org Dr. John J. Zone, M.D Department of Dermatology 4B454 School of Medicine 30 North 1900 East Salt Lake City, UT 84132-2409 Appointments: 801-581-2955 Office: 801-581-6465 45 Dr. Cynthia Rudert, M.D. 5555 Peachtree Dunwoody Rd. Suite 312 Alanta, Ga 30342 404-943-9820 National Institute for Diabetes and Digestive and Kidney Disease (National Institute of Health, NIH) http://digestive.niddk.nih.gov/ddiseases/pubs/celiac/ Resources for: Gluten Free Diet Support Organizations and Publications Celiac Sprue association (CSA) www.csaceliacs.org P.O Box 31700 Omahara, NE 68131-0700 Toll free: 877-CSA-CSA-4CSA Fax: 402-558-1347 Email: celiacs@csaceliacs.org 46 Gluten Intolerance Group (GIG) www.gluten.net 15110 10th Ave SW Suite A Seattle, WA 98166 Phone: 206-246-6652 Fax 206-246-6531 info@gluten.net The Celiac Disease Foundation www.celiac.org 13251 Ventura Blvd#1 Studio, City, Ca 91604 Phone: 818-990-2354 Fax: 818-990-2379 Email: cdf@celiac.org Resources: Support Magazines Living without (www.livingwithout.com) Gluten Free Living, (www.glutenfreeliving.com) 47 GIG Quarterly Newsmagazine (www.gluten.net) Lifeline-CSA (www.csaceliacs.org) Scott Free Newsletter (www.celiac.com) Informative Resource Web Sites www.enterolab.com www.breakintheviciouscycle.info www.clanthompson.com www.glutenfreedon.net www.celiac.com www.glutenfreemall.com www.mercola.com www.glutenfreerestaurants.org www.GFlinks.com www.GFCFdiet.com www.foodintol.com www.glutensensitivity.com www.greenpeople.com 48 APPENDIX A Gluten Free Grocery Program Grant for Women’s Mental Health and Sex/Gender Differences Research 49 Gluten Free Grocery Program Grant for Women’s Mental Health and Sex/Gender Differences Research Project Abstract This Women’s Mental Health and Sex/Gender Differences Research (R21) is written to allow a one year study for women diagnosed with bipolar disorder and provide the implementation of a Gluten Free Grocery Program (GFGP) to reduce the symptoms and side effects of psychotropic medications associated with bipolar disorder as defined by the DSM-IV. To address the problem of lack of adequate treatments and alternative methods for women with bipolar disorder the implementation of a Gluten Free Grocery Program will be administered for the course of one year in the San Francisco and East Bay area. The goal is to allow women a choice/option to current psychotropic drugs that have been proven harmful and have consistently caused severe side effects, which essentially stops those women from experiencing any level of recovery from symptoms. The goal of the Gluten Free Grocery Program is aimed to remove psychotropic medications and introduce a side effect free, gluten free diet. This grant’s endeavor is to increase the levels of functionality of the participants mentally and emotionally, which will allow them to regain more life vitally. 50 Problem Statement The number of women in the United States diagnosed with Bipolar disorder is estimated to be approximately 2.5 million (National Institute of Mental Health, 2009). The primary treatment modality for women diagnosed with Bipolar Disorder is psychotropic medication (Hall, 2007). However, it is estimated that 56% percent of these women diagnosed with bipolar disorder live below the poverty level and are typically exposed to much less nutritious and healthy option then others (Hall, 2007). Furthermore, it has been suggested that a diet that lacks proper nutrition or which contains food allergens, exacerbates psychiatric symptomatology (Marohn, 2008). Target Population This project is written for the benefit and recruitment of women with bipolar disorder as diagnosed by using the criteria of the DSM-IV, and includes Bipolar I, Bipolar II, Major Depressive Episodes, Manic Episodes, and Mixed Episodes. The subjects must be exhibiting emotional symptoms associated with the bipolar disorder. The subjects in this study have no age, religion or race restrictions. The subject must also voluntarily agree to abstain from recreational drugs and alcohol for the course of the research project. The author of this grant and project did not want to exclude any women with bipolar disorder who needed or wanted to participate in a gluten free diet. However, the majority of the subjects in the program will be selected based on a lack of financial ability to afford a gluten free diet. In addition, the subjects must live in the San Francisco, California or east bay area. The subject’s must be naturally born female. In addition, the consumption of sugar products will be greatly monitored and or reduced. 51 Literature Review A gluten free program has been utilized at San Quentin State Prison for four consecutive years. However, even with the success of the gluten free program at San Quentin, it has been implemented only on the male population (Hortiz, 2007). It is imperative the female population diagnosed with bipolar disorder be included if such research and case studies are to be beneficial. A growing number of psychiatrists find reactions to foods and various chemicals to be common in different forms of degenerative disease, and manifest in mental and/ or physical symptoms (Philpott, 2000). This suggests that the area of adverse reactions to food and additives is rapidly expanding and becoming legitimized by a scientific base (Edelman, 2003). Most antidepressants and other prescription drugs cause severe side effects, which usually discourage patients from taking their medications (Lakhan & Vieira 2008). There are great gender differences to differentiate diagnosis and treatment of bipolar disorder intended for men and women (Philpott, 2000). A women’s metabolism is controlled by hormones and these powerful chemicals play an important role in understanding bipolar disorder related women (Philpott). The following are highlights from Schizophrenia and Bipolar Education Day Stanford University on August 4, 2005, Bipolar I is equally prevalent among men and women; bipolar II (characterized by milder, ‘hypomanic’ episodes, but a greater burden of depression) is more commonly reported in women. Women with bipolar disorder tend to report more episodes of depression than men. Women also experience more ‘mixed’ episodes (episodes which have simultaneous features of both mania and depression. 52 Women are almost three times as likely as men to have a comorbid diagnosis. The effects that female hormones (menstrual cycle) can have on women with bipolar disorder. Menstrual cycle hormones (fluctuation in estrogen and progesterone, which can act on the activity of neurotransmitters serotonin, noradrenalin, and GABA) may exacerbate bipolar symptoms in women. Two of the studies utilized at Schizophrenia and Bipolar Education at Stanford University reported that 65% of women with bipolar disorder reported worse mood symptoms during their menstrual cycle. Pregnancy can also bring hormonal changes that can exacerbate symptoms for women with bipolar disorder. The issues described above are a few of the special needs that are important to the research of gender differences and are specific to this grant proposal for women with bipolar disorder. This Women’s Mental Health and Sex/Gender Differences Research Grant would allow a one year study with women with bipolar disorder with the implementation of a Gluten Free Grocery Program (GFGP) this research study will be established in the San Francisco and East bay area in agreement with, The Earth Circles Counseling Center in Berkeley, California and The Icarus Freedom Project group in San Francisco, California. Goals and Objectives The purpose of the Women’s Mental Health and Sex/gender Differences Research Grant is to demonstrate sex differences in hormone actions contribute to the differences in physiological and behavioral responses to stress relevant to cognitive and emotional regulation and mental disorders. The Gluten Free Grocery Program (GFGP) rationale is in provide alternative treatments to psychotropic medications to women with potential 53 gluten (food) allergies and that have been diagnosed with bipolar disorder as defined by the DSM-IV. This proposal is written to increase the understanding and provide quantitative and qualitative data on the specific gender differences of women’s needs that have been diagnosed with bipolar disorder. The Gluten Free Grocery Program will provide a safe and tolerable treatment to psychiatric medications and seeks to eliminate and reduce the symptoms associated with bipolar disorder in women. The base of this research is to, start the implementation of a Gluten Free Grocery Program (GFGP) combined with testing for the detection of any related allergies. There will be additional drug testing to eliminate the presence outside drug use to ensure the absence of street drugs, alcohol and the intake of sugar for the duration of the program. The Gluten Free Grocery Program will offer a nutritious gluten free diet as an alternative to pharmaceutical drugs for women diagnosed with bipolar disorder at no cost to the participants. The program will include support in the removal and reduction levels of all the participants’ psychiatric medications. Free Access to testing for allergy panel will also be a part of the program. This alternative treatment method will be used to measure the quality of life and record data of frequency of the recurring symptoms associated with women diagnosed with bipolar disorder. Project Goal: The Gluten Free Grocery Program wishes to achieve saturation in qualitative research and have all themes identified to assist with achieving the greatest decrease in bipolar symptoms 54 Objective 1 Testing and removal of gluten food allergies Activities: 1.1 Organize the volunteer recruitment of twenty women that have been diagnosed with bipolar disorder at The Earth Circles Counseling Center in Berkeley, California and/or The Icarus Project and Freedom Center in San Francisco, California. Nurses and staff will provide an hour presentation about information and the requirements of the Gluten Free Grocery Program and at that time ask that the participants sign consent forms to be considered for the program. 1.2 Appointments will be scheduled to test for gluten food allergies in a concession of intervals per the participant. Objective 2 The reduction and removal of psychotropic drugs Activities: 2.1 A presentation for the removal of psychotic drugs will also be scheduled. The participants are asked to bring a list of current medications and prescription bottles to our staff doctor. The individual participants and the medical doctor will map out the correct removal /weaning off psychotropic medications. A drug screening for street drugs, alcohol and sugar levels will be a mandatory component of the program participants, and the will be required to be tested in 30 day intervals. Objective 3 55 Target a decrease in the symptoms associated with women diagnosed with bipolar disorder by delivering gluten free groceries one time a week, after psychotropic medications have been removed. In addition, ask that participants continuingly journal their experiences. Activities: 3.1 Using bipolar disorder symptoms as described by DSM-VI assemble a qualitative (interpretive research) survey to be collected by grocery driver and be required before groceries are received. 3.2 To conduct a written passage summarizing the findings of the data analysis in a narrative discussion using qualitative research on the intensity or lack of (intensity) of bipolar symptoms. These data report forms will be picked up by the driver when groceries are delivered. The program coordinator will keep track of the forms to analyze the observations of symptoms reported by the participants. The purpose is to develop multiple perspectives. 3.3 The data reports must be filled out each week or participants will not receive groceries. Drivers deliver groceries to participants every week. Objective 4 Increase individual level of functionality Activities: 4.1 Have participants fill out a list of personal hobbies, chores, responsibilities, grooming and socializing activities that they would like to do each day but cannot manage, because of the severity of symptoms of bipolar disorder. Require a weekly report log of 56 qualitative data literature to set up relationships between the variables each day of the activities they were able to perform successfully on a scale component from 1-10. 4.2 Report level of satisfaction at being able to participate in activities and Working Hypotheses 1) Women diagnosed with bipolar disorder that are successfully tested for allergies, can reduce the symptoms associated with the illness if they are administered a gluten free diet. 2) The absence of the severe symptoms of bipolar disorder will allow the women diagnosed with bipolar disorder to experience more functionality in her everyday lifestyle. Methods, Strategies and Program Design The goal that is to be achieved is a one year study of women with bipolar disorder on a gluten free diet that would dramatically reduce the symptoms in accordance with the DSM -VI symptoms. The approach will be used to collect both quantitative and qualitative data relative to any changes that are observed by the patient from selfreporting to the liaison and observation made directly by the doctor or nurse. The proposed project aims to reduce the need for the long-term drug pharmaceuticals and their severe side effects by the removal of the patient’s dependence upon them. In addition, testing for allergies and adding gluten free diet for the course of 1year. The gluten free grocery program is specific to women who met the DSM -IV criteria of Bipolar disorder including Bipolar I, Bipolar II, Manic Depressive Episodes, Mixed Episodes, and Hypomanic Episodes. 57 There is no age, or culture specification. The target population would include female gender; and have a documented diagnosis of bipolar disorder in addition to lacking the financial ability to afford a gluten free diet. The staff will assist with supportive needs for the women diagnosed with bipolar disorder in the Gluten Free Grocery Program. The setting would be conducted at the Icarus project group and/or The Earth Circles Counseling Center in Berkeley, California. The intensity and frequency of the Gluten free Grocery Program is as follows: groceries will be picked up and delivered once a week, reporting will occur a once week (liaison will contact patient at home if needed for reporting), the patient will also be required to met with the physician once a month or nurse once a month for first 6 months. Evaluations The evaluation impact of the Gluten Free Grocery Program is to allow women diagnosed with bipolar disorder who are participants, to experience an alternative treatment and aid them in removal of psychotropic medications that can exacerbate the symptoms and cause severe side effects associated with the disorder. Objectives of the Evaluation 1) test and remove gluten foods that cause may allergies 2) decrease the symptoms associated with bipolar disorder 3) increase individual level of functionality (mental and emotional) Information Management System The Statistical Package for the Social Science (SPSS) program will be utilized to enter data collected from the quantitative measurement tools developed by the Icarus 58 Freedom Project Group and The Earth Circles Counseling Center. The tools will measure self reported bipolar symptoms and medical staff reported bipolar symptoms. Qualitative data will be reported collected through participant logs, progress journals, interviews, and consulting group meeting notes. All data will be complied and formatted the project coordinator. Impact Evaluation The program coordinator will access the project objectives through the process and outcome evaluation tests from pre and post test, surveys, and data collected throughout the one year program. This data will be compiled into an evaluation report that will demonstrate the impact of the program on the target populations Organizational Structure The Icarus Freedom Project Group and The Earth Circles Counseling Center are dedicated to improving the lives of diverse individuals and families throughout the east bay area in California. These centers provide counseling and support services for individuals diagnosed with bipolar disorder. Project Management and Staffing The Gluten Free Grocery Program (GFGP) will consist of one project coordinator. The project coordinator will be responsible for the administration and management of the program budget, development and implementation of the program evaluation. The budget will include travel to doctor’s appointments, gluten free reporting, allergy tests, and price of monthly groceries. The physician will be responsible for the up to the first six month of reporting, during the process of participants weaning off psychotropic drugs. The part- 59 time nurse will be utilized to assist the physician with reporting. However, the nurse will be included for the entire twelve months of the study, to ensure the safety of the participants. One part- time nutritionist will collaborate with the participants in grocery selection and allergies maintenance. A full time delivery driver will pick up groceries, deliver them to participants and return self-reporting data reporting forms. 60 Budget and Budget Justification A. Personnel Program Coordinator Doctor Nurse Nutritionist Delivery Driver Twelve Month Total Annual Salary FTE Months Cost Subtotal $57,000 $1,500 $14,500 $5,400 $6,500 12 6 12 9 6 $57,000 $1,500 $14,500 $5,400 $15,000 $93,400 1.0 .0625 .0625 .0625 1.0 $57,000 $1,500 $14,500 $5,400 $15,000 B. Benefits (25% of Personnel Costs) 1. Payroll Taxes 2. Employee Benefits a. Medical Benefits b. Dental Benefits c. Life Insurance d. Worker’s Compensation Insurance e. Others Twelve Month Total $23,350 C. Indirect Costs $5,000 D. Travel 1. Local (Mileage) a. Monthly Mileage (200 miles) b. Number of Work Months (6 months) c. Reimbursement Rate ($.55/mile) $660 $5,000 Twelve Month Total E. Equipment 1. Telephones: purchase, installation, wiring ($50 x 10) $500 2. Personal Computers $2,500 3. Printer $400 $660 Twelve Month Total F. Office Materials and Supplies 1. General Office Supplies (&400 x 12) 2. Volunteer Recruitment materials 3. Postage ($60/month x 12) $3,400 Twelve Month Total $4,800 $1,000 $720 $6,520 61 G. Program Costs 1. Gluten Free Groceries 2. Allergy Lab Tests 3. Drug Tests Twelve Month Total H. Contractual/Consultants Not Applicable I. $48,000 $10,000 $5,000 $63,000 Construction Not Applicable J. Office Space ($5000/month x 12 months = $60,000) Twelve Month Total $60,000 K. Others Not Applicable Annual Budget Subtotal $255,330 Total Requested Budget $195,330 62 REFERENCES Barnes, C., & Mitchell, P. (2005). Considerations in the management of bipolar disorder in women. Australian and New Zealand Journal of Psychiatry, 39(8), 662-673. Bourre, J. (2005). Dietary omega-3 fatty acids and psychiatry: mood, behavior, stress depression, dementia and aging. The Journal of Nutrition, Health and Aging, 9, 31-39. Casper, R. (2004). Nutrients, neurodevelopment, and mood. Current Psychiatry Reports, 6:425-429. Edelman, Eva. (2003). Natural Healing for Bipolar disorder: a compendium of Nutritional approaches. 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