eSelf-help for AM Protocol

Evidence-based Synthesis Program Systematic Review Protocol
Project Title: Online Self-help Programs for Alcohol Misuse
Investigators: Eric Dedert, PhD; Caroline Freiermuth, PhD; Adam Hemminger; J. Murray
McNeil, PhD; Isabel Ross, MD; Roy Stein, MD
ESP Investigators: Jennifer McDuffie, PhD; John W. Williams Jr., MD, MHSc
ESP Core Staff: Avishek Nagi, Liz Wing
Search Librarian: Megan Von Isenburg
Nominator: Ken Weingardt, PhD, National Director, Mental Health Web Services
Operational Partner: Mental Health Services; Mental Health Services (Daniel R. Kivlahan,
PhD, Director, Addictive Disorders); National Center for Prevention (Margaret Dundon, PhD.
National Program Manager for Health Behavior)
I. Background
The economic and health burden of alcohol use disorders is widely recognized,1 as is the need
for effective interventions to reduce this burden.2,3 Broad public access to the internet is now a
reality, and this has opened many new avenues to reach individuals who misuse alcohol.4 Types
of alcohol problems, for the purpose of this review, will be guided by the definitions in Table 1.
Table 1. Definitions of the Spectrum of Alcohol Misusea
Risky or hazardous
Harmful use
Alcohol abuse
Consumption of alcohol above recommended daily, weekly, or per occasion amounts.
Consumption levels that increase the risk for health consequences.
A pattern of drinking that is already causing damage to health. The damage may be either
physical (e.g., liver damage from chronic drinking) or mental (e.g., depressive episodes
secondary to drinking).
A maladaptive pattern of alcohol use leading to clinically significant impairment or
distress, as manifested by 1 of the following within a 12-month period:
Recurrent alcohol use resulting in a failure to fulfill major obligations at work, school,
or home (e.g., repeated absences or poor work performance related to alcohol use;
alcohol-related absences, suspensions, or expulsions from school; or neglect of
children or household)
Recurrent alcohol use in situations in which it is physically hazardous (e.g., driving
an automobile or operating a machine)
Recurrent alcohol-related legal problems (e.g., arrests for alcohol-related disorderly
Continued use despite persistent or recurrent social or interpersonal problems
caused or exacerbated by the effects of alcohol (e.g., arguments with spouse about
consequences of intoxication or physical fights)
(And) the symptoms have never met the criteria for alcohol dependence.
Alcohol dependence
(alcoholism, alcohol
A maladaptive pattern of alcohol use leading to clinically significant impairment or
distress, as manifested by 3 of the following at any time in the same 12-month period:
Tolerance, as defined by either of the following:
o A need for markedly increased amounts of alcohol to achieve intoxication or
desired effect
o Markedly diminished effect with continued use of the same amount of alcohol
Withdrawal, as manifested by either of the following:
o The characteristic withdrawal syndrome for alcohol
o Alcohol (or a closely related drug) is taken to relieve or avoid withdrawal
Alcohol is often taken in larger amounts or over a longer period than was intended
A persistent desire or unsuccessful efforts to cut down or control alcohol use
A great deal of time is spent in activities necessary to obtain alcohol, use alcohol, or
recover from its effects
Important social, occupational, or recreational activities are given up or reduced
because of alcohol use
Use continues despite knowledge of a persistent or recurrent physical or
psychological problem that is likely to have been caused or exacerbated by alcohol
(e.g., continued drinking despite recognition that an ulcer was made worse by
alcohol consumption)
a Reproduced with permission from Jonas DE, Garbutt JC, Amick HR, et al. Behavioral counseling after screening for alcohol
misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med.
Meta-analyses have shown that face-to-face screening and brief interventions (SBIs) are
effective.5-7 The wide use of SBIs is hampered, however, by barriers such as adequate funding,
time, and adequately trained personnel.8,9 On the other hand, self-help for problem drinking
provided over the internet (i.e., electronic self-help or e-self-help) may prove to be a useful
extension of the reach of SBIs. E-self-help is available in brief and longer forms. Single-session,
electronic, personalized normative feedback is one type of brief intervention for problem
drinking available over the internet. Feedback is provided on the individual’s alcohol
consumption in relation to recommended guidelines for low-risk drinking behavior in a relevant
age and sex cohort.10 Such comparison of the individual’s drinking pattern to their peer group
could help them to realize they have a problem and seek further help.11 More extended forms of
e-self-help are also available and are based on behavioral self-control, cognitive behavioral
therapy (CBT), motivational interviewing, or a combination of these models.12-14 It is
recommended that these extended interventions be used for up to 6 weeks to initiate a change in
drinking behavior.15
E-self-help interventions have the potential to reach individuals with drinking problems who
wish to remain anonymous, have little time for traditional therapy, need therapy to be available
during nonstandard business hours due to shift work, live at a great distance from traditional
therapy, or cannot afford such therapy.16,17 This is especially true of “no-contact” interventions;
i.e., those in which participants work through the intervention without contact with a mental
health professional.18,19
Most studies evaluating the efficacy of e-self-help programs have been conducted in college
students.20-22 Generally, these studies have found that e-self-help has a favorable impact on
problem drinking among youth. Studies evaluating the efficacy of e-self-help programs among
adult, noncollegiate populations are fewer in number, but show promising results as well.23
However, to date, there are no such studies evaluating the efficacy of these programs in
Veterans24 and current reviews in the non-college student population are out of date. Given that
Veterans can encounter most if not all of the barriers to accessing care for problem drinking
listed above, e-self-help may prove to be a promising avenue, especially for the younger, more
internet-savvy Veterans returning from OIF/OEF.
The VA/DoD Integrated Mental Health Strategy consists of a series of 28 Strategic Actions
designed to help both agencies better meet the unique mental health needs of OIF/OEF Veterans.
One of these strategic actions resulted in the creation of a series of web-based self-help
programs. The purpose of this report is to conduct a systematic review of randomized controlled
trials assessing CD-based, web-based, and mobile applications of e-self-help for problem
drinking. We will evaluate these studies for changes in alcohol consumption and effects on the
medical health and social and legal consequences of problem drinking. This evidence synthesis
will be used to inform the decision about whether to implement e-self-help for alcohol misuse,
and how best to implement these programs.
Project Timeline:
Kickoff call: October 30, 2013
Project start: November 7, 2013
Anticipated draft report due: June 6, 2014
Anticipated final report submitted: July 31, 2014
II. Key Questions
The key research questions for this systematic review were developed after a topic refinement
process that included a preliminary review of published, peer-reviewed literature; consultation
with internal partners and investigators; and consultation with content experts and key VA
stakeholders. During the topic refinement process, the scope of this review was narrowed to
focus on alcohol misuse and alcohol use disorder. This study protocol was reviewed by a broader
group, including representatives from Mental Health Web Services (Ken Weingardt), Mental
Health Services (Daniel Kivlahan), and National Center for Prevention (Margaret Dundon).
The key questions (KQs) for this systematic review are:
KQ 1: For electronic self-help (e-self-help) interventions targeting adults who misuse alcohol or
who have a diagnosis of alcohol use disorder (AUD), what level, type, and modality of user
support is provided (e.g., daily telephone calls, weekly email correspondence), by whom (e.g.,
professional counselor, technical support staff); and in what clinical context (adjunct to therapy
or primary intervention)?
KQ 2: For adults who misuse alcohol but do not meet diagnostic criteria for AUD, what are the
effects of e-self-help interventions compared with inactive controls?
KQ 3: For adults at high risk for AUD (e.g., AUDIT-C >8), or who have a diagnosis of AUD,
what are the effects of e-self-help interventions compared with inactive controls?
KQ 4: For adults who misuse alcohol, are at high risk for AUD, or who have a diagnosis of
AUD, what are the effects of e-self-help interventions alone or used in combination with face-toface therapy compared with face-to-face therapy alone?
A. Population
The population will be adults (age 18 years and older) across the spectrum of risk related to
alcohol misuse, ranging from risky or hazardous use to severe AUD. We will take care to
consider the type of assessment used for alcohol misuse and the differences in standards for
alcohol consumption between countries.
For KQ 1 and KQ 2, anyone with a positive AUDIT-C or equivalent using established
thresholds but who have not been assessed for or diagnosed with an AUD.
For KQ 1, KQ 3 and KQ 4, anyone with an AUDIT-C or equivalent who score above
a threshold that is associated with a high risk for AUD (e.g., AUDIT-C ≥8), or with a
diagnosis of AUD.
We will include studies that enroll patients with dual diagnosis (e.g., depression and alcohol
use) or dual substance abuse (e.g. ETOH and other SUD) as these studies are relevant to the
Veteran population. We will exclude studies that enroll pregnant women, but will identify
any studies in this population, so that stakeholders will have information on the number of
studies conducted in this population.
B. Intervention
The intervention may be designed for self-guided treatment or with the support of a clinician,
but it must be a therapy delivered primarily by a computer-based mechanism or as an adjunct
to therapy, as follows:
Delivery mode: CD-ROM, web-based, interactive voice response (IVR) and electronic
devices including mobile phones (e.g., text messaging) and “Health Buddy.”
Treatment model: We will include all interventions derived from evidence-based
therapeutic models designed to reduce alcohol use. Evidence-based therapeutic models
include brief motivational interviewing, CBT, behavioral self-control, and 12-step
programs. We will exclude interventions based on psychodynamic or family therapy and
therapies that are not targeted at an individual (e.g., parent–child dyads). KQ 4 includes
e-self-help interventions used in combination with face-to-face therapy. For these studies,
the computer-based intervention may be as simple as computer-based self-monitoring.
Treatment phase: The intervention is designed for treatment, not primary prevention.
An example of an intervention that does not meet these criteria is: computerized screening
only without any computer-based treatment component.
C. Comparators
A list of the acceptable comparators follows, with the key idea being that we must be able to
isolate the effect of the e-self-help intervention from the comparator intervention:
KQ 1: Descriptive, no comparator
KQ 2 and KQ 3: Usual care, waitlist control, and information or attention control
KQ 4: Face-to-face therapy
D. Outcomes
Adherence to the intervention (e.g., number of planned sessions completed, proportion
completing the planned intervention)
Effects on alcohol consumption patterns such as standard drinks/week, heavy drinking
episodes, and achieved recommended drinking limits
Effects on associated health problems such as mortality, alcohol-related liver problems,
alcohol-related accidents (motor vehicle accidents or injuries)
Legal problems such as assault, battery, child abuse, or resisting or obstructing an officer
Medical utilization such as emergency department visits or hospital admissions (number
of admissions, hospital days) related to the disorder being treated
Effects on validated functional status measures of global or mental health functioning
such as SF-36, Sheehan Disability Scale
Adverse effects such as onset of or increase in illegal substance use, smoking, anxiety,
interference with the physician-patient relationship
E. Timing
Follow-up is measured at 6 months or greater following randomization.
F. Settings
Patients may be identified from general medical (including emergency departments), mental
health, or community populations. Patients do not have to be engaged in treatment with a
clinician and may be identified through self-assessments without a definitive clinical
III. Analytic Framework:
IV. Methods
A. Criteria for inclusion and exclusion of studies in this systematic review
Inclusion criteria
Study design: RCTs with N ≥50. The sample size requirement is designed to exclude
small pilot studies that typically are underpowered and have more methodological
problems than larger trials. Studies with small samples sizes and no treatment effect are
also less likely to be published than those finding a treatment effect, increasing the risk of
publication bias. However, we will track citations excluded due to n<50 at the request of
our stakeholders.
Adults aged 18 years or older with alcohol misuse (KQ2), at high risk of AUD or
diagnosis of AUD (KQ3).
Outpatients in any setting (general medical setting, emergency department, and
community or patients not engaged in clinical care who are enrolled through selfassessments). We will include studies where patients are enrolled during a hospitalization
if the majority of the intervention is delivered on an outpatient basis.
Intervention must be a computer-based therapy adhering to evidence-based treatment
principles and used for individually delivered treatment. Examples of interventions that
do not meet the intervention criteria are interventions designed for primary prevention;
interventions that are primarily telemedicine-based (e.g., therapy via video chat or
telephone interactions); disease management interventions where treatment for alcohol
misuse is only one component of a more comprehensive intervention; interventions
targeted at dyads (e.g. parent-child); and therapies that are delivered primarily in face-toface encounters with only minor computerized supplementation (e.g., limited text
messages or online materials that are purely informational). In addition, we will exclude
interventions that utilize computerized screening, but do not use a computerized
component for treatment.
The comparator for KQ 2 and KQ 3 is usual care not involving psychotherapy; waitlist;
information or attention control. For KQ 4, the comparator is face-to-face treatment.
Study must report effects on at least one of the following relevant outcomes at least 6
months after randomization and initiation of intervention:
o Alcohol consumption patterns
o Associated health problems (e.g., mortality, alcohol-related liver disease)
o Legal problems
o Medical utilization (e.g., emergency department visits or hospital admissions
related to the disorder being treated)
o Validated functional status measures of global or mental health functioning (e.g.,
SF-36, Sheehan Disability Scale)
o Adverse effects (e.g., illegal substance use, smoking, anxiety, interference with the
physician-patient relationship)
Article is a full publication in a peer-reviewed journal. Examples of reports that are not
included are meeting abstracts and dissertations.
Article is an English-language publication.
Study is conducted in North America, Western Europe, Australia/New Zealand (rationale
is to include economically developed countries with sufficient similarities in health care
system and culture to be applicable to U.S. medical care).
Studies are conducted since 2000 (rationale is that brief interventions emerged in the
1980s, personal computers in the early 1980s, and the internet in the 1990s). Based on
our assessment of studies included in existing systematic reviews, the earliest relevant
publication was in 2004.
Exclusion criteria
Not an English-language publication
Inpatient settings
B. Literature search strategies
We will conduct a primary search of MEDLINE® (via PubMed®), the Cochrane Registry,
Embase®, and PsycINFO from 2000 to present. We will further evaluate the bibliographies of
systematic or nonsystematic reviews for relevant studies. We anticipate using a combination
of MeSH keywords and selected free-text terms to search titles and abstracts. To ensure
completeness, search strategies will be developed in consultation with a master librarian. To
assess for publication bias, we will search to identify completed but
unpublished studies meeting our eligibility criteria, an indicator of possible publication bias.
Using prespecified inclusion/exclusion criteria, titles and abstracts of articles included in the
existing reviews and identified through our primary search will be reviewed by two
reviewers for potential relevance to the KQs. Articles included by either reviewer will
undergo full-text screening. At the full-text screening stage, two independent reviewers must
agree on a final inclusion/exclusion decision. Articles meeting eligibility criteria will be
included for data abstraction. All results will be tracked in both DistillerSR, a web-based data
synthesis software program (Evidence Partners Inc., Manotick, ON, Canada), and EndNote®
reference management software (Thomson Reuters).
C. Data abstraction and data management
Data from published reports will be abstracted into a customized DistillerSR database by one
reviewer and overread by a second reviewer. Disagreements will be resolved by consensus or
by obtaining a third reviewer’s opinion when consensus cannot be reached. Data elements
include descriptors to assess applicability, quality elements, intervention/exposure details,
and outcomes.
Key characteristics abstracted will include patient descriptors (including age, gender, race,
education, and experience with therapy), setting, features and dose of the computer-assisted
intervention, features of the comparator, and outcomes as described previously. We will
place special emphasis on describing the key components of the intervention including the
modes and intensity of support, the clinical discipline and training of the interventionist, the
clinical context, and the intervention dose. Multiple reports from a single study will be
treated as a single data point. When critical data are missing or are unclear in published
reports, we plan to request supplemental data from the study authors. Key features relevant to
applicability include the match between the sample and target populations (e.g., comorbidity,
age, education level) and the training and experience of the clinician.
D. Assessment of methodological quality of individual studies
Quality assessment will be performed by the researcher abstracting or evaluating the included
article; this initial assessment will then be overread by a second, highly experienced
reviewer. Disagreements will be resolved between the two reviewers or when needed by
arbitration from a third reviewer.
We will use the key quality criteria described in the Agency for Healthcare Research and
Quality’s (AHRQ’s) “Methods Guide for Effectiveness and Comparative Effectiveness
Reviews”25 adapted to this specific topic and customized to RCTs. For RCTs, these criteria
are adequacy of randomization and allocation concealment, the comparability of groups at
baseline, blinding, the completeness of followup and differential loss to followup, whether
incomplete data were addressed appropriately, the validity of outcome measures, and conflict
of interest. We will assign a summary quality score (good, fair, or poor) to individual studies.
E. Data synthesis
We will summarize the primary literature by abstracting relevant data. We will develop a
summary table describing the key outcomes and the types of study designs used to evaluate
computer-based alcohol interventions. We will then determine the feasibility of completing a
quantitative synthesis (i.e., meta-analysis) to estimate summary effects. Feasibility depends
on the volume of relevant literature, conceptual homogeneity of the studies, and
completeness of results reporting. We will aggregate outcomes when there are at least three
studies with the same outcome, based on the rationale that one or two studies do not provide
adequate evidence for summary effects. If meta-analyses are feasible, we will explore the
possibility of subgroup analyses to explore the consistency of effects across conditions (e.g.,
mild severity of alcohol misuse vs. moderate-severe alcohol misuse). Analyses will be
conducted separately for intervention vs. inactive control, interventions using computerized
alcohol treatment as an adjunct to face-to-face therapy vs. face-to-face therapy, and
interventions comparing two different intensities or levels of clinical support for
computerized therapy. We will stratify analyses for effects on alcohol use into the following
groups: college students, adults, and older adults. We will also conduct subgroup analyses
and meta-regression analyses to examine effects of key intervention components. We
recognize that subgroup analyses involve indirect comparisons (across studies) and are
subject to confounding. These moderator analyses will evaluate the effects of: intervention
dose, level of clinical support, and commercially available versus non-commercially
available programs. Results of these moderator analyses will be interpreted cautiously and
be considered hypothesis generating. For other variables of interest (e.g., gender) that are not
amenable to valid subgroup comparisons as part of our meta-analyses, we will abstract
subgroup analyses from the primary studies and conduct a qualitative synthesis of these
We anticipate that studies may report both dichotomous outcomes (e.g., proportion achieving
a prespecified treatment response) and continuous outcomes (e.g., change in drinks per
week). If quantitative synthesis is possible, dichotomous outcomes will be combined using
risk ratio or odds ratio, and continuous outcomes will be combined using mean differences in
a random-effects model. Since symptom scales are likely to vary across studies, we anticipate
using the standardized mean difference (Hedges g) for continuous outcomes. Change in
symptoms is often measured by both self- and interviewer-administered scales. When studies
report more than one measure of symptom response (e.g., self-report of alcohol consumption
and self-report of alcohol-related consequences), we will use the mean effect of the two
outcome measures. We will explore potential sources of heterogeneity including the specific
mental illness, symptom severity, the context of the intervention (e.g., therapy as an adjunct
vs. computer-based therapy as the primary intervention but in a clinical context vs. computer
aided therapy without other clinical care), comfort with computers (or age as a proxy), and
the comparator (e.g., waitlist control vs. more active control). We will evaluate for statistical
heterogeneity using visual inspection and Cochrane’s Q and I2 statistics. Publication bias will
be assessed using findings from the search (described previously) and
using funnel plots (when there are >10 studies in an analysis).
If a quantitative synthesis is not feasible, we will analyze the data qualitatively. We will give
more weight to the evidence from higher quality studies with more precise estimates of
effect. A qualitative synthesis would focus on documenting and identifying patterns in
efficacy and safety of the intervention across conditions and outcome categories. We will
analyze potential reasons for inconsistency in treatment effects across studies by evaluating
differences in the study population, intervention, comparator, and outcome definitions.
F. Grading the evidence for each key question
The strength of evidence for each key question will be assessed using the approach described
in AHRQ’s “Methods Guide.”25 In brief, this approach requires assessment of four domains:
risk of bias, consistency, directness, and precision. Additional domains are to be used when
appropriate: coherence, dose-response association, impact of plausible residual confounders,
strength of association (magnitude of effect), and publication bias. These domains will be
considered qualitatively, and a summary rating will be assigned after discussion by two
reviewers as high, moderate, or low strength of evidence. In some cases, high, moderate, or
low ratings will be impossible or imprudent to make. In these situations, a grade of
insufficient will be assigned.
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