Research Update: PTSD Gary H. Wynn, MD, FAPA Associate Professor / Assistant Chair Department of Psychiatry Uniformed Services University of the Health Sciences Bethesda, MD Disclaimer The opinions and statements in this presentation are the responsibility of the author and such opinions and statements do not necessarily represent the policies or opinions of the Uniformed Services University of the Health Sciences, the United States Army, the Department of Defense, the United States or their agencies. Agenda Background and Current work on PTSD Epidemiology Stigma and Barriers to Care Psychotherapy Pharmacotherapy Complementary and Alternative Medicine Future Directions for Research Epidemiology Community First Responders Loved Ones Individual DSM-IV-TR A: Event Broadened definition Very similar B: Re-experiencing (Intrusion) C: Avoidance DSM-V Effectively Split in Two A: Event B: Intrusion (Re-experiencing) C: Avoidance D: Negative Alterations in Cognitions/Mood D: Arousal E: Duration Very similar E: Arousal Identical F: Clinically Significant Distress F: Duration Identical G: Clinically Significant Distress H: Not attributable to substance/medical DSM-IV-TR EVENT DSM-V A: The person has been exposed to a traumatic event which both of the following were present: A: Exposure to actual or threatened death, serious injury, or sexual violence in one (or more) of the following ways: A1: experienced, witnessed, or was confronted with events that involved actual or threatened death/serious injury A1: Directly experiencing the traumatic event(s) A2: response involved intense fear, helplessness, or horror A3: Learning that the traumatic event(s) occurred to a close family member or close friend A2: Witnessing, in person, the event(s) as it occurred to others A4: Experiencing repeated or extreme exposure to aversive details of the traumatic event(s) DSM-IV-TR C: Persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: C1: Efforts to avoid thoughts, feelings, or conversations C2: Efforts to avoid activities, places, or people C3: Inability to recall an important aspect of the trauma C4: Markedly diminished interest in significant activities C5: Feeling of detachment or estrangement from others C6: Restricted range of affect C7: Sense of foreshortened future DSM-V C: Persistent avoidance of stimuli associated with the traumatic event as evidenced by on or both of the following: C1: Avoidance of or efforts to avoid distressing memories, thoughts, or feelings C2: Avoidance of or efforts to avoid external reminders D: Negative alterations in cognitions and mood associated with traumatic event(s) D1: Inability to remember an important aspect of the traumatic event(s) D2: Persistent exaggerated negative beliefs about oneself, others, or the world D3: Persistent, distorted cognitions that lead the individual to self blame D4: Persistent negative emotional state D5: Markedly diminished interest in significant activities D6: Feelings of detachment or estrangement from others D7: Persistent inability to experience positive emotions DSM-IV-TR DSM-V Specifiers Acute (<3 months) Chronic (>3 months) With Delayed Onset With Dissociative Symptoms - Depersonalization - Derealization With Delayed Expression Subthreshold PTSD Adjustment Disorder Adjustment Disorder Anxiety Disorder NOS Other Specified Trauma- and Stressor-Related Disorder Unspecified Trauma- and Stressor-Related Disorder DSM Discordance Hoge CW, Riviere L, Wilk J et al. The prevalence of post-traumatic stress disorder (PTSD) in US combat soldiers: a head-to-head comparison of DSM-V versus DSM-IV-TR symptom criteria with the PTSD checklist. Lancet Psychiatry Aug 2014 Pre-Stress Stress Post-Stress PTSD Genetics Depression Subjective Response And Recovery Prior Stress And Stress Prep Substance Use Disorders Chronic Pain Somatic Disorders Other Psychiatric Disorders Extreme Stress Adapted from John Krystal (APA 2013) Responses to Trauma Distress Responses Mental Health Health Risk Behaviors (changed behavior) Benedek DM and Wynn GH. Clinical Manual for Management of PTSD. American Psychiatric Press, Inc 2010 Stigma and Barriers to Care From the 2010 National Survey on Drug Use and Health Stigma 66 Lack of perceived need 60 Perceived lack of effectiveness 66 40 54 Want to solve on own 68 40 Unsure where to go 49 35 Fear of forced hospitalization Men Women 22 23 Stigma 24 0 17 10 20 30 40 50 Agree or Strongly Agree, % Kessler RC. J Clin Psychiatry. 2000;61(suppl 5):4-12. 60 70 80 Patients Making Treatment Contact, % Lifetime Probability of Treatment Contact 7% contact within year of PTSD onset and 12-year median delay to first treatment contact 100 95% 94% 90% 90 88% 86% 80 65% 70 60 Panic Disorder Dysthymic Disorder Wang PS, et al. Arch Gen Psychiatry. 2005;62:603-613. Bipolar Disorder Major Depression GAD PTSD Lu MW, Duckart JP, O’Malley JP et al. Correlates of Utilization of PTSD Specialty Treatment Among Recently Diagnosed Veterans at the VA. Psychiatric Services 2011 Psychotherapy Psychotherapies SR SUBSTANTIAL A • Trauma-focused psychotherapy that includes components of exposure and/or cognitive restructuring; OR • Stress inoculation training SOMEWHAT C • • • • • • I • Family therapy UNKNOWN Patient Education Imagery Rehearsal Therapy Psychodynamic Therapy Hypnosis Relaxation Techniques Group Therapy From VA/DoD Clinical Practice Guideline for The Management of Post-Traumatic Stress (2010) • Web-Based CBT • Dialectical Behavior Therapy • Acceptance & Commitment Therapy Level A Psychotherapy Choices Patients should be offered one of the evidence-based traumafocused psychotherapeutic interventions that include components of exposure and/or cognitive restructuring; OR stress inoculation training. Choice should be based on symptom severity, clinician expertise, and patient preference, and may include: Exposure therapy (e.g., Prolonged Exposure) Cognitive therapy (e.g., Cognitive Processing Therapy) Stress management therapy (e.g., SIT) or Eye Movement Desensitization & Reprocessing (EMDR) VA/DoD Guideline: Therapy Selection 1. Explain the range of available and effective therapeutic options for PTSD to all patients with PTSD 2. Patient education is recommended as an element of treatment of PTSD for all patients and family members 3. Patient and provider preferences should drive the selection of evidence-based psychotherapy and/or evidence-based pharmacotherapy as 1st line treatment 4. Psychotherapies should be provided by practitioners who have been trained in that particular method 5. A collaborative care approach to therapy administration, with care management, may be considered Meta-analysis of Individual Psychotherapy Treatment Effect Size Number of Studies Prolonged Exposure 1.38 (0.9-1.86) 10 Cognitive Processing Therapy 1.69 (1.27-2.11) 3 Stress Inoculation Therapy 1.37 (0.8-1.93) 2 Exposure + Cognitive 1.52 (1.08-1.95) 3 Virtual Reality 1.01 (0.37-1.65) 4 EMDR 1.04 (0.44-1.65) 10 Adapted from Watts BV, Schnurr PP, Mayo L et al. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry 2013 Prolonged Exposure in Veterans Yoder M, Tuerk PW, Price M et al. Prolonged exposure therapy for combat-related posttraumatic stress disorder: comparing outcomes for veterans of different wars. Psychological Services 2012 PCL Score Chard KM, Ricksecker EG, Healy ET et al. Dissemination and experience with cognitive processing therapy. J Rehabil Res Dev 2012 Cognitive Behavioral Conjoint Therapy for PTSD Improves PTSD Symptoms Clinician-Administered PTSD Scale CBCT WL 80 70 60 50 40 30 20 Baseline Mid-Treatment/ 4Week Wait Adapted from Monson CM, Fredman SJ, Macdonald A et al. Effect of cognitive-behavioral couple therapy for PTSD: a randomized controlled trial. JAMA 2012 (Adapted with permission from Schnurr, APA 2012) Post-Treatment/ 12Week Wait The Benefits of Cognitive Behavioral Therapy for PTSD Persist Long-Term 126 female sexual assault survivors with PTSD, followed 6.2 years after treatment (range = 4.5-10 years) CAPS PTSD Severity Comparable to 171 initial participants Remission at follow up: 77.8% Cognitive Processing Therapy 82.5% Prolonged Exposure Adapted from Resick PA, Williams LF, Suvak MK et al. Long-Term Outcomes of Cognitive-Behavioral Treatments for Posttraumatic Stress Disorder Among Female Rape Survivors, J Consult Clin Psychol 2012 (Adapted with permission from Schnurr, APA 2012) Pharmacotherapy SR SIG BENEFIT A SSRI SNRI B C SOMEWHAT UNKNOWN NONE or HARM Mirtazapine Atypical antipsychotics (as adjunct) Prazosin (for sleep/nightmares) TCAs Nefazodone MAOIs (phenelzine) Prazosin (for global PTSD) D Adapted from VA/DoD Clinical Practice Guideline for The Management of Post-Traumatic Stress (2010) Benzodiazepines[Harm] Tiagabine Guanfacine Valproate Topiramate Drug Sertraline (Zoloft) Paroxetine (Paxil) * Study Findings Robb et al. (2010); 10 week No significant reduction in double-blind RCT of sertraline PTSD symptoms at 10 (67) v placebo (62) in children and weeks adolescents with PTSD (ages 617) Panahi et al. (2011); 10 week double-blind RCT of sertraline (35) v placebo (35) in Iranian vets with combat related PTSD Significant improvement in sertraline group Simon et al. (2008); Double-blind RCT of paroxetine CR (11) v placebo (12) for PE refractory PTSD No significant improvement compared to placebo - including sertraline v PEx v combination study Ongoing Trials 6* 2 Drug Duloxetine (Cymbalta) Venlafaxine (Effexor) Study Findings Villareal et al. (2010); 12 week open label trial of duloxetine in military vets with PTSD (20) 9/20 participants classified as responders (>20% reduction on CAPS) Walderhaug et al. (2010); 8 week naturalistic study of duloxetine in male vets with PTSD and comorbid MDD (21) Improvements in both PTSD and MDD by week 8 Davidson et al. (2012); Post-hoc analysis of pooled data from two double-blind flexible dose RCTs of venlafaxine for PTSD 10 item CD-RISC predictive of CAPS score change Ongoing Trials 0 1 Venlafaxine ER 12-week Flexible dose 538 randomized 350 completers ~10% difference in remission Davidson J, Rothbaum BO, Tucker P et al. Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo-controlled study. J Clin Psychopharmacol 2006 Drug Prazosin (Minipress) Study Findings Raskind et al. (2007); 8 week trial of prazosin v placebo (34) for trauma nightmares and sleep disturbance Significant benefit over placebo Taylor FB. (2006); Addition of daytime prazosin to nighttime prasozin for continued daytime symptoms (11) Significant benefit over placebo Thompson et al. (2008); Treatment of Non-nightmare distressed (NNDA) awakenings in combat PTSD (22) Significant improvement in NNDA and PTSD symptoms Byers et al. (2010); Long term comparative effectiveness of Prazosin (62) v quetiapine (175) for night sxs No short term differences; less discontinuation with prasozin (AE related) Germain et al. (2012); Prasozin (18) v behavioral sleep intervention (17) v placebo (15) for sleep dist. in vets Prasozin and behavioral superior for both sleep and daytime PTSD sxs Raskind et al. (2013); Twice daily Prazosin v Placebo for Combat PTSD with nightmares in US Soldiers returned from Iraq/Afganistan (67) Significant Improvement CAPS, CAPS hyperarousal, nightmares, and sleep quality Ongoing Trial(s) 4 Drug Olanzapine (Zyprexa) Risperidone (Risperdal) Aripiprazole (Abilify) Drug Eszopiclone (Lunesta) Study Findings Carey et al. (2012); 8 week double-blind flexible dose RCT of olanzapine (14) v placebo (14) in non-combat PTSD Significant reduction in CAPS score by week 8; substantial weight gain Krystal et al. (2011); 6 month double-blind RCT of adjunctive risperdal (246) for antidepressant resistant chronic military PTSD No significant benefit over placebo; risperdal had more side effects Youssef et al. (2012); Open label pilot study of flexible dose aripiprazole monotherapy (10) in M/F vets with PTSD Improvements in PTSD and depression measures Study Pollack et al. (2011); 3 week double-blind RCT cross-over of eszopiclone (12) v placebo (12) Findings Significant improvement in CAPS, SPRINT, and PSQI Ongoing Trials 0 0 1 Ongoing Trials 1 Drug Study Hydrocortisone Drug Topiramate (Topamax) Delahanty et al. (2013); Double-blind RCT of 10 days of 20mg BID hydrocortisone (32) v placebo (32) initiated within 12 hours of trauma Study Yeh et al. (2011); 12 week doubleblind RCT of topiramate (35) v placebo (35) Findings Lower PTSD and depression symptoms; Higher quality of life measures Ongoing Trial(s) 3 Findings Ongoing Trial(s) Significant improvement in PTSD symptoms (ave. dose ~100mg) 3* Complementary and Alternative Medicine What is CAM? A group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medical. National Center for Complementary and Alternative Medicine Natural Products Herbal medicines, dietary supplements, probiotics Mind and Body Medicine Meditation, Acupuncture, Yoga, Progressive Relaxation Manipulative and Body-Based Practices Massage therapy, Spinal Manipulation NCCAM website: nccam.nih.gov Other ways to Organize CAM Based on validity of proposed mechanism: 1) Consistent with current medical perspectives and understanding of pathophysiology 2) Unsure of mechanism for perceived benefit 3) Violates basic laws of physics/chemistry/biology Or Based on Modality Type: 1) Interventions (e.g. Acupuncture) 2) Care Delivery Method (e.g. Computer Based Therapy) 3) Personal Activities (e.g. Recreational Therapy) Why is CAM Research so complicated? 1. Hypothesis development Design believable studies 2. Definition and Validation of Diagnosis Define PTSD using validated instruments Establish Chronicity of symptoms 3. Treatment Design Standardize the intervention 4. Measuring outcome Use established assessment tools to evaluate Include follow-up assessments 5. Interpreting Results Identify primary and secondary outcome measures prior to the trial Intervention Virtual Reality (VR) Study Findings Ready et al. (2010); VR v present centered therapy in Vietnam Vets with PTSD (11) No group differences; Trend towards effect for VR comparing symptom change Reger et al. (2011); VR for PTSD in military mental health clinic (24) Significant reduction in symptoms (PCL-M) McLay et al. (2011); RCT of VR for PTSD in Active Duty with combat related PTSD Significant improvement in PTSD symptoms (CAPS) Miyahira et al. (2012); VR exposure therapy vs. minimal attention over 10 sessions Significant improvement in PTSD symptoms (CAPS) McLay et al. (2012); Open-label, single group, treatment development project (20) Improvements in PTSD, depression and anxiety Intervention Yoga Acupuncture Study Findings Telles et al. (2010); 1 week of yoga v WLC post natural disaster (22) Decrease in sadness in treatment group compared to increased anxiety in WLC Descilo et al. (2010); Yoga breath v yoga breath + exposure v WLC for PTSD post natural disaster (183) Significant reduction in symptoms with Yoga breath and Yoga breath + exposure Stankovic L (2011); 8 week trial of Integrative Restoration Yoga for PTSD in military and veterans (11) Reductions in rage, anxiety, intrusive memories and improvement in relaxation Hollifield et al. (2007); Acupuncture v CBT v WLC for PTSD (58) Significant improvement in both acupuncture and CBT groups compared to WLC Wang et al. (2012); Electroacupuncture v. paroxetine for earthquake related PTSD (138) Significant reduction in CAPS, HAMD, HAMA. Electro-acupuncture more significant than paroxetine Future Directions X X X X New Molecular Entities X X Repurposing X X Proteomics/Metabolomic s X X Genetics X X Neuroimaging X Combat Delivery Location X X New Modalities X X Comorbidities X X Family Interventions Alternative Therapies Stigma Reduction Treatment Engagement Best Practices X X Motor Vehicle Dissemination Dismantling X X X X X X X X X X X Sexual Assault X X X X X X Geriatrics X X Study Group X X X X X X Adults X Disaster X X X Pediatrics Pharm Biomarkers Increased Options Psychotherapy