Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression
Phase: NA
Conditions: Depression
Sponsor: VA Office of Research and Development

 
Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression 
 
NCT02057042 
 
September 4, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

E. RESEARCH APPROACH/METHODS 
E.1 Study Design This will be a Hybrid I randomized controlled trial (RCT) of peer-supported cCBT (PS-cCBT) 
compared to enhanced usual care (EUC) among Veterans with new diagnoses of depression in primary care.  
Patient assessments will occur at baseline, 12 and 24 weeks following enrollment.  
(Study flow of the RCT is shown in Figure 2.) 
Concurrent with the RCT, we will collect administrative and qualitative data that will allow us to better 
understand the context and process of the PS-cCBT implementation including barriers/facilitators to patient 
recruitment, integration of the peer specialist into the Primary Care-Mental Health Integration team, challenges 
and successes in maintaining contact with patients, and patient perspectives of peer specialist calls and cCBT 
content and helpfulness.   
 
 
Figure 2: Overall Study Flow  
E.2 Study Sites and 
Patient Population 
We have chosen our 
study sites, Ann Arbor, 
Battle Creek, Detroit), to 
ensure adequate numbers 
for the study (estimated at 
330 patients, see below), 
patient diversity and 
inclusion of rural and urban 
areas.  
All study VA medical 
centers have a full range of 
services, including primary 
care clinics and 
comprehensive (inpatient 
and outpatient) mental 
health services. These three 
medical centers also have a 
total of 9 associated 
Community Based 
Outpatient Clinics (CBOCs). 
The John D. Dingell VA 
Medical Center in Detroit is located in a highly urban area and serves a large number of African American 
Veterans; whereas, many of the CBOCs from Battle Creek serve rural areas.  
During FY 2010, the three study sites (Ann Arbor, Battle Creek, and Detroit) and their associated 
CBOCs served 6,283 patients who met criteria for a new depressive episode, of which 3,312 were diagnosed 
with new episode of depression in primary care. Approximately, 11% of these patients were women, 25% were 
aged 44 or younger, 53% were ages 45-64, and 22% were ages 65 or older.  Of patients with known race, 27% 
were African American.   In prior RCTs conducted in several of these study sites, we were successful in 
recruiting 17% African Americans and 20% women.  Thus, we have been quite successful in recruiting women 
and have also recruited African Americans in proportion to their percentage nationally (18%) of the VA patient 
population with depression diagnoses.(11) 
  
E.3 Patient Eligibility Criteria 
We have deliberately made our inclusion criteria for this study broad and our exclusion criteria narrow 
to increase the generalizability of our findings to VA primary care patients with new depressive episodes.  
Patients will be eligible for the study if they: 1) have been diagnosed with a new episode of depression 
in primary care at any of three VA study sites or associated CBOCs; 2) have a current PHQ-9 score > 10; 3) 
are not receiving mental health care outside of VHA; 4) have broadband internet access at home or confirm 

willingness, ability, and a plan to go to their VA or library to complete cCBT modules; 5) have familiarity with 
email and internet use (see below); and 6) have stable access to and ability to communicate by telephone.    
We will assess patients’ familiarity and self assessed comfort with the internet with questions such as 
“How frequently do you use the internet?” and “How often do you email?”. Our threshold for being computer 
familiar will be relatively low, requiring only that individuals have an existing email account that they access at 
least once per week. In our pilot work, we found patients who met these criteria had a higher likelihood of 
completing the cCBT modules.  
We will include patients who have suicidal ideation that is not immediately threatening. Suicidal 
ideation is common among patients in treatment for depression.  Approximately 30-50% of patients in 
depression treatment endorse some level of suicidal ideation, although only 2-3% are a current suicide 
risk.(56)  Peer specialists will follow the protocol used within their facility mental health services when patients 
confide suicidal thoughts. These protocols are clearly outlined for all staff at each of these facilities, and will be 
reviewed with study peer specialists during their training.  The protocol for research staff when patients divulge 
suicidal thoughts upon screening is outlined below. 
 
We will also include patients in the study who are starting an antidepressant medication as this is 
the de facto treatment nationally in VA primary care settings for depression and also for our three study sites, 
with 70% of VA patients with new episodes of depression filling at least one antidepressant prescription. (See 
section E.6.a.)  Prior studies of Beating the Blues (BTB) indicate there is no interaction between cCBT program 
use and either antidepressant treatment or depression severity. Benefits from the BTB and antidepressant 
medication have been additive. (35)  However, we will consider whether a patient has filled an antidepressant 
prescription in our randomization scheme. 
Exclusion criteria for the study will be narrow and include: 1) a diagnosis of schizophrenia, 
schizoaffective disorder, MDD with psychotic features, or Bipolar I in the past 12 months; 2) a positive screen 
for moderate or severe substance use in the past 6 months (per DSM 5); or 3) an immediate risk of suicide, 
requiring hospitalization or urgent evaluation (as evidenced by suicidal plan or intent).  
  
 
 
E.4 Patient Recruitment 
Pharmacy data, patient diagnoses and CPT codes from 
outpatient visits are updated nightly from VISTA to the Corporate Data 
Warehouse (CDW), and study analysts have extensive experience in 
using these data. We will use these administrative data for preliminary 
identification of patients who may have new diagnoses of depression 
made in primary care.  As in our pilot work, at this preliminary stage 
we will identify patients who may have new episodes of depression in 
primary care as those with at least two diagnoses of depression or 
one depression diagnosis accompanied by an antidepressant fill 
within 120 days of the diagnosis and  no prior depression diagnoses 
or antidepressant fills within 120 days of the index date of their 
depression diagnosis. Patients must also have no diagnoses of 
schizophrenia, schizoaffective disorders, Bipolar I disorder, or major 
depression with psychosis in the prior year.  
We will use the ICD-9 codes for depressive disorders that are 
used in the National Depression Registry to identify potentially eligible 
patients.(11) Patients will be identified in all of the study facilities’ 
primary care clinics, not just PC-MHI clinics, as only a minority of 
primary care patients with depression are currently seen in PC-MHI. 
Patients who are not seen in PC-MHI are also less likely to be offered 
any psychotherapy option.  
After identification of potentially eligible patients via 
administrative data, we will review patients’ electronic medical records 
to assess whether they meet additional study eligibility criteria (e.g. no 
mention of use of mental health care outside of the VHA in charts, no 
exclusionary diagnoses in chart notes, etc.)  
 
Our study team has had extensive experience in conducting chart reviews for purposes of eligibility 
screening. As in several of our past studies, chart reviews will be assisted through the use of EMERSE, a 
Review of Administrative Data
Review of Electronic Chart 
Notes
Consultation with Provider
Letter to Patient
Telephone Screening
In-Person Screening and 
Enrollment
Figure 3: Patient Identification and Screening

“Google-like” system for the electronic medical record, developed by David A. Hanauer MD.  We have used 
EMERSE in several HSR&D studies to rapidly screen patients for study enrollment. EMERSE maintains an 
audit trail and has an easy to use, intuitive search engine for free-text documents. Use of EMERSE speeds 
chart searches markedly and provides a more consistent, accurate and objective method of 
abstracting.(57)(58) 
 
After identifying potentially eligible patients, we will briefly consult with patients’ primary care clinicians to 
confirm that there are no clinical contraindications to study participation. (Our co-investigators at each site will 
assist in educating clinicians about the study and advocate for cooperation and assistance in recruiting 
patients.) 
Letters will then be sent to potentially eligible patients, informing them about the study.  Patients will be 
given a phone number which they can use to contact study staff and either indicate their interest in the study or 
their wish to “opt out” of further contact.  If patients have not contacted study staff within7 days of the mailing, 
staff will telephone patients to further describe the study, answer questions, and assess patients’ interest in 
participating. Research personnel will make several attempts to contact patients, calling at different times of 
the day.  
Patients who are interested in the study will be screened for current severity of depression symptoms 
using the nine-item Patient Health Questionnaire (PHQ-9).  The PHQ-9 has high levels of sensitivity and 
specificity for major depressive disorder, can be used over the telephone, and quantifies depression 
severity.(59)(60)  Patients with PHQ-9 scores > 10, who are not receiving mental health services outside of the 
VA and who have broadband internet access will be eligible for the study. 
Patients who endorse suicidal ideation on the PHQ-9 will be asked additional questions from a 
structured screener assessing suicidal history and current intent or plan. For patients who meet predetermined 
criteria on this screener, appropriate action plans are specified. (See suicide screener and action plans in 
Appendix A.) A similar telephone screener has been in place and successfully used in team members’ prior 
RCTs. When staff who are screening identify patients deemed at higher risk for suicide, study clinicians or the 
patient’s personal clinicians have been able to contact the patients in a timely manner for further evaluation 
and assistance.   
Patients who remain eligible after telephone screening will be invited to an in-person interview at their 
local VA facility or CBOC. At this appointment, potential enrollees will learn more about the study and complete 
the informed consent process. Those patients agreeing to study participation and providing written informed 
consent will be randomized to either PS-cCBT or EUC. Patients will also complete their baseline assessments 
at this time, using Qualtrics, to familiarize them with use of this online data collection platform as their follow 
up-assessments will be conducted using this platform. (See section G.3.) 
If the patient is randomized to PS-cCBT, the peer specialist will attend part of this interview to be 
introduced. If this is not logistically possible, research staff will introduce the peer specialist via video-
conference on a secure internet connection.   
 
Based on our work in the DIAL-UP reciprocal peer support study, we expect to be able to recruit 
approximately 1-2 patients at each site per week (3-6 per week total) for the PS-cCBT study.   
At the time of our first in-person patient contact, we will begin our efforts to retain enrolled patients. 
During the initial assessment, patients will be asked to supply the names, phone numbers, and addresses of at 
least two family members, friends, or acquaintances—and give consent for staff to contact these individuals 
should we lose touch with the patient. As noted below, for the first 12 weeks, patients in the control condition 
will be receiving bi-weekly mailings giving depression self-management tips and patients in the PS-cCBT 
condition will be receiving peer specialist calls. These regular contacts will help maintain patients’ connection 
to the study.  We will also send an additional mailing with study updates and logos to all patients at 18 weeks 
to help maintain a connection to the study and increase willingness to complete the final assessment.  When 
needed, research staff will also check patient appointments and admissions to meet directly with patients near 
their scheduled assessment times.  
We note that with similar procedures, we have been able to maintain a follow rate of >85% in prior 
RCTs even over longer time frames. 
 
 
E.5 Patient Randomization 
Eligible patients will be randomized to either enhanced PS-cCBT or to EUC. Random assignment will 
be coordinated and completed centrally at the study coordinating site to ensure that the RAs and clinical staff 
will not able to determine the likely treatment assignment for the next enrollee.  Randomization will be stratified 
by study sites, and to increase balance in prognostic factors between groups, minimization will be used for 

randomization within each site.  Factors to be included in minimization will include: 1) age group (≥55 vs. <55), 
2) gender, 3) antidepressant medication fill in prior 90 days vs. not, and 4) depression severity (PHQ-9 ≥ 15 vs. 
<15) at time of baseline measures.  Minimization method allows balancing on multiple factors, and we will 
utilize MinimPy, a free open-source, desktop minimization randomization program in this study.(61)(62)(63) 
 
E.6 Study Groups and Intervention Description 
The PS-cCBT intervention and enhanced usual care (EUC) will be delivered over 12 weeks. The 
Beating The Blues (BTB) program consists of 8 interactive modules and recommends completing one module 
per week. However, we will provide 12 weeks of peer specialist support for completion of these 8 modules.  
Table 3 lists the components that will be delivered in each of the study treatment arms. 
 
Table 3: Components of Treatment Arms 
Enhanced  Usual Care 
PS-cCBT  Intervention 
• Usual depression care 
• Patient education regarding treatment 
options, including antidepressants and 
evidence-based psychotherapies 
• Bi-weekly mailings with depression self 
management tips and local resources 
• Notification to the primary care clinician at 
12 and 24 weeks if patient shows significant 
clinical worsening 
• Usual depression care 
• Access to cCBT program—Beating the 
Blues  
• Veteran peer specialist assigned 
• Peer specialist contacts at least once per 
week for 12 weeks (in-person or by 
telephone) to provide support and 
encourage cCBT participation and 
completion  
• Notification to the primary care clinician 
at 12 and 24 weeks if patient shows 
significant clinical worsening 
I 
E. 6.a Enhanced Usual Care:  
 
As outlined above, in 2010, primary care patients newly diagnosed with depression in the study primary 
care settings (AA, DET, and BC and associated CBOCs) received the following treatments. Approximately 
70% received an antidepressant fill, and 51% of these patients (36% overall) had an adequate trial of 
antidepressant (84 or days supply of antidepressant in the 114 days after first AD fill).  Approximately 22% of 
patients had one psychotherapy visit within 14 weeks of their depression diagnosis and 3% had 8 or more 
psychotherapy visits within the 14 weeks following their depression diagnosis.  
We assume that usual care delivered to our EUC patients will be similar to that outlined above, 
although our enhancements to usual care may increase treatment use slightly. (We provide these 
enhancements to increase the credibility and acceptability of usual care for patients randomized to this arm, 
please see Section E.7.)  
Patients randomized to EUC will receive the following enhancements: 1) patient education regarding 
the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression 
Helpbook by Wayne Katon and colleagues which provides basic information on depressive disorders, self-
management strategies, and effective communications, 3)  information about how to access local VA mental 
health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings 
with depression management tips. 
 
E.6.b Peer-Supported cCBT:  
Patients in the PS-cCBT intervention will receive usual depression care described above and will also 
receive access to Beating the Blues (BTB), the cCBT program that currently has the most research support 
and is recommended by the UK National Institute for Health and Care Excellence (NICE).  The 8-module BTB 
program will be supported by the peer specialists for 12 weeks. (The peer support component for PS-cCBT 
is described below.)  
cCBT Program: Beating the Blues (BTB) program includes eight interactive therapy modules, each of 
which is approximately 50 minutes in duration.  Patients are advised to complete one module per week. The 
program teaches both cognitive and behavioral strategies over the eight modules and is tailored to the patient’s 
reported problems. Videos are used to elucidate presented concepts and homework is assigned and easily 
printed for reference and completion. The Beating the Blues program allows patients to flexibly stop and start 
modules. However, each module is designed to build upon the content in the preceding modules.  

The program modules are: 1) Getting Started, 2) Goal Setting and Automatic Thoughts, 3) Common 
Thinking Distortions in Anxiety and Depression, 4) Changing Unhelpful Thinking, 5) Inner Beliefs, 6) Inner 
Beliefs (continued) and Attributional Style and 7) Attributional Style (continued), and 8) Conclusion and Coping 
with Setbacks.  
The “Getting Started” module introduces the patient to the program and establishes the structure of all 
program modules. Patients learn about the symptoms of anxiety and depression and the Cognitive Behavioral 
Therapy model is explained.  Video vignettes elucidate CBT principles. The patient is assisted in identifying 
his/her symptoms (which are input into the program) and targeting the problems on which they would like to 
work in the subsequent modules. 
The second module, “Goal Setting and Automatic Thoughts”, orients the user to the ABC (Antecedent- 
Behavior- Consequence) model and the concept of “automatic thoughts.” Patients learn how to catch and 
record their automatic thoughts in an attempt to gain greater control over their intensity, duration, and impact. 
They also start to work on behavioral strategies such as activity scheduling. In the third module, “Common 
Thinking Distortions in Anxiety and Depression”, patients learn about common thinking errors and how to 
recognize the type of errors that they most commonly make.  They are also taught to use controlled breathing 
techniques to manage more intense emotions and are encouraged to work on their behavioral activation 
strategy.  
The fourth module, “Changing Unhelpful Thinking”, begins with a review of the previous session’s 
assigned homework. Patients are then introduced to four techniques to challenge their negative thoughts.  
These techniques are then modeled in video vignettes. Patients are again encouraged to continue using the 
behavioral strategies they learned in session two. 
 
 
The fifth module, “Inner Beliefs”, orients the patient to “inner,” or “core beliefs”. They are encouraged to 
use their own experience as evidence against negative, inaccurate core beliefs. They are also coached again 
on earlier behavioral strategies. The sixth module, “Inner Beliefs and Attributional Style”, continues to provide 
the patient with strategies for gathering evidence that does not support their maladaptive inner beliefs and to 
replace it with more helpful ones. They also learn about attributional style and its impact on affect. Finally, 
patients are provided a choice of three new behavioral strategies on which to work (i.e., Sleep Management, 
Graded Exposure, and Task Breakdown). 
 
The seventh module, “Attributional Style, continued” teaches strategies for modifying one’s attributional 
style.  Patients also continue to work on the new behavioral strategy they chose in Module Six.     
 
The final module, “Conclusion and Coping with Setbacks”, completes the program by providing a review of 
the materials and concepts in the first seven modules. Progress towards the patient’s goals that were recorded 
at the beginning of program are reviewed. Patients are also helped to develop an action plan that incorporates 
the new strategies and techniques they have learned from the program. They are encouraged to think about 
and prepare for setbacks and to repeat previous cCBT modules if desired or needed.   
 
Other BTB Functions: Besides providing interactive CBT content, the Beating the Blues program provides 
a variety of tracking, assessment, notification and reminder functions. For patients, the program provides 
feedback on modules that have been completed, provides selective tailoring of modules based on patient 
input, and sends e-mails reminders to patients when the next BTB session is due.  
 
BTB also allows the supervising clinician and/or program administrator to embed selected 
questionnaires in the 8 interactive modules for clinical purposes. The administrator can determine the 
frequency with which the selected questionnaires are presented to patients (e.g., every module, every other 
module, etc.) and the juncture within the module at which questionnaires will be presented  (pre- or post-
module CBT content). Please note that these questionnaires are used for clinical purposes to allow 
patients to self-monitor and to allow the overseeing clinicians to monitor patient progress and contact 
individuals who are not responding or engaging in the program.  We will likely embed the PHQ-9 and 
GAD-7 in every other module for these clinical purposes.  
 
(We note that study assessments will be completed on-line separately using the Qualtrics platform at 
baseline, 12, and 24 weeks following enrollment. Patients will receive incentives for completing study 
assessments on Qualtrics but will not receive incentives for completing program questionnaires which are part 
of the clinical cCBT program.) 
 
 
The Beating the Blues program also allows for queries about whether the user has had any suicidal or 
homicidal thoughts, and if so, the seriousness of their intent on a 0 through 8 scale. The administrator can 
determine the level of severity that would prompt immediate notification. The BTB program also allows 
information to be presented regarding local crisis services and emergency phone numbers to further assist 

users who might be in crisis.  In this study, we will include phone numbers for the relevant local  VHA clinical 
services, clinically trained research staff, and  for the VA Crisis Line. 
Peer Specialist Support of BTB: Peer specialists will assist patients in initially accessing the BTB 
program. They will also call patients weekly for the first 12 weeks following enrollment to support completion of 
the 8-module cCBT program. In all patient interactions, the peer specialists will be supportive, encouraging 
cCBT participation while respecting patient autonomy and not focusing solely on cCBT completion.  
Participants will be also be able to contact their assigned peer specialist between “check-in” calls if they would 
like additional peer support or assistance.  
Training: As in our pilot study, part of the VA peer specialists’ training will include completing the BTB 
program themselves under the supervision of VA study psychologists. Peer specialists will review the modules 
in real time with the psychologists and complete homework assignments with feedback.  They will also review 
the sections of the VA peer specialist manual that are most relevant to supporting patients in their recovery 
journey in addition to the protocol for serving as a supporter of cCBT.  Peer specialists will receive additional 
training on identifying situations in which study staff or health care providers should be contacted, including 
emerging risk factors for suicide. Peers will also review with study psychologists their facility’s specific protocol 
for dealing with suicidal crises, including use of the Veterans Crisis Line. 
Ongoing Peer-Specialist Activity and Supervision: Similar to a prior study examining the efficacy of 
technician support for an internet cCBT program for depression,(38) peer specialists will be given a guide to 
the topics covered in each BTB program module and a list of the goals and homework that each patient has 
generated as part of the program.(38) The peer specialist will not provide clinical advice but may talk about 
their own experience with BTB and how s/he handled homework in similar areas (i.e., identifying their own 
cognitive errors).  If patients have more specific questions regarding CBT content, peer specialists will refer 
patients to the appropriate place in the cCBT modules where more information can be found or refer the 
patients’ questions to their supervising psychologist.  (Depending upon the circumstances, the psychologist 
may call the patient directly to answer questions or provide a written answer that can be delivered via email or 
through the peer specialist.) The peer specialists will also inform the supervising clinician of any perceived 
urgent issues in cCBT participants’ mental health. They will complete templated notes in CPRS after their 
contacts with patients. These templates will include checklists for important elements covered during the calls 
(i.e, general social support, shared my recovery story, discussed cCBT program, technical issues, discussed 
Veteran’s experience with cCBT module/or home practice, etc.)  For further detail, please see draft template 
for progress notes in the PS-cCBT manual, Appendix B.) Peer specialist notes will all be countersigned by the 
their supervising clinician, at which point, the patient’s primary care clinician may also be added as a co-signer. 
 
Interactions with the PC-MHI Team: Peer specialists will be part of the Primary Care-Mental Health 
Integration (PC-MHI) team during the trial and will attend PC-MHI team meetings. At least one of their 
supervisors will come from the PC-MHI team.  
 
We note that patients for this study will be recruited from primary care more generally rather than only 
from PC-MHI-- as only 9% of patients nationally and 12% of patients at the three study sites receive new 
diagnosis of depression in PC-MHI.   However, once patients are enrolled into the study and randomized to the 
PS-cCBT program, they will be considered to be receiving PC-MHI services and “taken back” to the PC-MHI 
team. Peer specialists will discuss their interactions with the PS-cCBT patients with their PC-MHI supervisor, 
who will work in concert with Drs. Abraham and Nelson , who will oversee all peer specialist training and 
supervision across sites.  
 
E.7 Alternatives, Methodological Issues and Rationale for Study Design Choices  
 
Recognizing that there will always be limitations arising from RCT design,(64) several study design issues 
were considered as we formulated this proposal. Below, we outline why we made several key design choices, 
recognize other choices that might have been made, and discuss the trade-offs involved in our design 
decisions.  
E.7.a Choice of Control Arm: We have chosen to use an enhanced usual care (EUC) control group. 
The level of support offered in the EUC offers credibility to this control condition, addressing potential issues 
with patient expectancy. However, it does not include an equivalent amount of “attention”. We do not feel the 
lack of a full attention control raises issues in study interpretability because offering additional attention and 
monitoring in the form of supportive, low cost, peer specialist interactions is an inherent part of the intervention. 
We note that we will assess potential mediators that are specific to peer specialists interactions (i.e. reduction 
in self-stigma) rather than applicable to general non-specific attention.  

 
We also could have compared PC-cCBT or cCBT alone to traditional in-person therapy; however, other 
comparisons were of more pragmatic interest.  Even if traditional in-person therapy has larger effect sizes, it is 
expensive and logistically complex to deliver. Also, despite enormous efforts to bolster the capacity to deliver 
traditional in-person therapy, a small minority of Veterans with depression currently complete an adequate 
treatment trial.  Thus, we were more interested in comparing a highly flexible treatment option (PS-cCBT) to 
usual care.  PS-cCBT includes both basic psychotherapeutic content and a supportive relationship, and it may 
address issues that are currently barriers to completing in-person evidence-based psychotherapies, including 
therapist supply, travel difficulties, and patient time constraints.      
 
Finally, we chose not to restrict treatment options in usual care, for example, by prohibiting 
antidepressant treatment, care management, or other psychotherapy.  This decision was based on the ethical 
consideration of not depriving patients of any effective treatments that they might receive under naturalistic 
conditions. (Antidepressant medication is the default treatment in VA primary care, with 70% of patients with 
new diagnoses of depression receiving an antidepressant fill.)  As prior studies of cCBT have shown no 
interactive effect of antidepressant treatment on cCBT effectiveness, study findings are likely to remain easily 
interpretable.  We note that we deliberately consider antidepressant use in our randomization/minimization 
scheme. We also note that few individuals with new diagnoses of depression in primary care currently receive 
any definitive trial of psychotherapy.  
 
As recommended when using enhanced usual care as a control group, we will carefully track and describe 
all care that patients receive during the study period. 
E.7.b Choice of intervention arm: We chose the PS-cCBT as the intervention arm for several reasons. 
First, this intervention has synergies with ongoing operational initiatives within the VHA, providing evidence-
based treatments for depression AND providing recovery-oriented services.  cCBT is currently widely  
disseminated in the UK as an evidence-based option for depression care but needs to be supported to be most 
effective.  Peer specialists, who constitute a rapidly growing workforce in mental health within the VHA, are 
ideal candidates to support this effort for reasons elucidated through out this proposal. Combining these 
initiatives allows us to examine, for the first time, a low cost, flexible and evidence-based treatment option  
(cCBT) supported in a manner that is likely to increase its effectiveness and promote patient recovery.  
E.7.c Choice of location: Finally, although cCBT has been successfully piloted in specialty mental health 
settings and we included VA patients from specialty mental health in our pilot, we decided to focus on providing 
PS-cCBT for primary care patients. The body of work supporting cCBT’s effectiveness for primary care patients 
is more robust than the literature on cCBT in specialty mental health settings.  Also in our pilot, although 
patients in primary care showed similar reductions in depressive symptoms as patients recruited from specialty 
mental health, they rated the PS-cCBT intervention as more useful, relevant, and easier to use.  Patients in 
primary care are also likely to receive fewer intensive psychotherapy services than patients treated in specialty 
mental health.  
 
 
E.8 Patient Safety and Confidentiality Issues 
  
   
 
 E.8.a Patient safety: Threats to patient safety will consist primarily of lack of treatment response or 
worsening of depressive symptoms and the emergence of suicidal ideation or behaviors. We note that these 
threats can occur for all VA patients in depression treatment, including patients in both PS-cCBT and EUC. 
Patients enrolled in in either arm of this study will have all the access to depression care that is usually 
provided to VA patients plus additional safety precautions and monitoring.  Importantly, all study patients 
will continue to receive usual care from their treating clinicians and have full access to these clinicians 
throughout the study. 
 
 Threats to safety of patients in this study may also arise from the study interventions. Specifically, 
patients in the PS-cCBT arm may become more distressed or symptomatic through working with the cCBT 
modules or through their interactions with peer specialists. To mitigate this possibility, all peer specialists will 
be supervised by clinicians who are part of the PC-MHI team, who in turn, will work in concert with Drs. Nelson 
and Abraham who will oversee peer specialists’ training and activity across study sites.  
 
  Patients’ clinical status will also be systematically followed in the BTB program through the use of 
standardized scales (an inherent part of this clinical intervention) so that clinical worsening will be readily 
identified. This level of symptom monitoring is as intensive as that provided in proactive care management. If 
patients’ symptoms are increasing significantly over time (i.e. depression scores increase >25% from baseline 
at more than one follow up clinical assessment point), then the supervising clinician will contact the patient and 
discuss their treatment progress, treatment preferences, and options for increasing the intensity of treatment.  

Also, at the end of PS-cCBT participation, patients who continue with problematic symptoms will be 
encouraged to progress on to more intensive treatments. Please note that, PS-cCBT is not designed to 
“replace” more intensive and proven interventions, such as face-to-face individual CBT, but to serve as a first 
intervention that may provide sufficient benefit but could also serve as a “stepping-stone” to more intensive 
care if needed.   
 
 Potentially, patients in the study may develop suicidal ideation. Again, this will be monitored as part of 
the cCBT program as often as in proactive care management. The  cCBT program will include information 
about local emergency resources as well as the Veterans Crisis Line which can provide immediate assistance. 
Research staff will also be available in a timely fashion  and  will  further assess the seriousness of any 
emerging suicidal ideation or behaviors within 48 hours.  Patients’ clinicians will also be informed and asked to 
follow up.  
 
 Study staff will have less frequent contact with EUC patients; however, if they become aware of 
significant suicidal ideation during the 12 week or 24 week assessments (follow-up assessments on the 
Qualtrics platform will be reviewed within 48 hours of receipt),  study clinicians will again contact the patients 
for further evaluation and assistance and their usual care clinicians will be informed.  The Qualtrics platform will 
also have information about local emergency resources and the VA Crisis Line. (Please see further detail in the 
Human Participants section.) 
 
 
E.8.b Confidentiality: Throughout the study, IRB and HIPAA guidelines will be followed to ensure the 
privacy of patient data.  The BTB program takes extensive precautions to guard patient data security.  
Likewise, the Qualtrics platform that will be used to collect study assessment data, has transport layer security 
(TLS) encryption, HTTP referrer checking, and is hosted by data centers that are SSAE-16 SOC II certified. As 
soon as patients consent to study participation, they will be assigned a unique study ID number. A file linking 
patients’ identifying information and their study ID will be stored in a password protected file on a secure 
server, with study data stored in a separate electronic file with only the study ID. At the study’s conclusion, the 
electronic file linking study IDs with patient identifiers will be destroyed. All research data will be presented in 
aggregate form only.  
 
We note that as a VA multi-site randomized trial, this project will be overseen by the VA HSR&D Data 
Safety and Monitoring Board.  We will report all serious adverse events within 14 days as well as summary 
data on all outcomes semi-annually or annually to the DSMB. (Please see further detail in the Human 
Participants section.) 
 
 
E.9 Study Measures 
The primary predictor of interest will be PS-cCBT intervention versus enhanced usual care (EUC).  
Below, we describe study measures in each domain of interest (symptoms, functioning, and recovery 
constructs such as coping self efficacy and hope). We designate the measures that will serve as primary and 
secondary outcomes. We note that some measures may serve as outcome measures when addressing 
one aim and as potential mediators when addressing another aim.  
 
 
E.9.a  Primary Outcome Measures 
Inventory of Depression Symptoms – Self Report (IDS-SR) is a 31-item self-report instrument for measuring 
the severity of depression symptoms among adults. Each item is rate on a four-point scale (0-3), and aggregate 
scores range from 0-84. The IDS-SR has been shown to be reliable, with Cronbach’s α’s in the range of 0.92-0.94 
(Rush et al., 1996).  
Veterans RAND 12-Item Health Survey (VR-12) is a measure of functional status adapted from the 
Medical Outcomes Study Short Form-36 for use among Veterans. The measure assesses physical functioning 
(PF), role limitations due to physical problems (RP), bodily pain (BP), general health perceptions (GH), 
energy/vitality (V), social functioning (SF), role limitations due to emotional problems (RE), and mental health 
(MH). The VR-36 has somewhat greater precision at the lower end of the health status continuum than the SF-
36.  The VR-12 has been used in quality management systems in the VHS (Kazis et al., 2006).  
The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid 
proxy for the longer Q-LES form. It consists of 14 items that patients rate on a 5-point scale to indicate their 
satisfaction with a variety of life domains, including physical health, mood, work, household activities, social 
relationships, etc.(69) The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in 
numerous studies of depression, including the NIMH funded STAR*D study.(69)(70)(71) 

 Recovery Assessment Scale - Short Form (RAS-SF): This 20-item scale is a shorter version of the 
RAS(72) and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, 
and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity 
when compared to quality of life, social support, and symptomatic scales. (73) 
Alcohol Use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C) which 
assesses average alcohol consumption (quantity and frequency) and binge drinking (6 or more) over the past 
3-months.(84) Recent literature support the internal consistency, test-retest reliability, and accuracy of the 
AUDIT-C in identifying at-risk alcohol use.  
 
 
E.9.b  Secondary Outcomes   
 
Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) is a 16-item scale consisting of two factors, 
Behavioral Activation and Cognitive Restructuring. The scale shows construct validity, appears sensitive to 
change among patients undergoing CBT treatment, and predicts reduction in depressive symptoms.(76) 
 
Adherence with Antidepressant Medications: Team members have extensive experience using VA 
pharmacy data to assess adherence. We will construct medication possession ratios for antidepressants 
prescribed for the 3 months following enrollment and for 3-6 months following enrollment. In addition to 
pharmacy data, The 8-item Morisky Medical Adherence Scale (MMAS) will also be used to assess adherence 
and may be particularly helpful if patients receive some antidepressant medication fills outside of the VA.  The 
MMAS-8 has been shown to be reliable (Cronbach’s alpha = .83) and to be significantly correlated with the 
validated 4-item MMAS (Pearson correlation: 0.64, p<.05) (Moriskey et al., 2008).  
 
Receipt of VA and non-VA Traditional In-Person Psychotherapy: We will review enrolled patients’ VA 
medical record notes to determine their receipt of any traditional in-person psychotherapy and their completion 
of 8 in-person psychotherapy visits within 12 and 24 weeks following enrollment. We will also assess whether 
the Veteran received psychotherapy that was depression focused and evidence-based, assessing the 
presence of key phrases in notes that denote CBT, ACT, or IPT treatment. We will also determine non-VA 
psychotherapy use, using the Cornell Services Index, as patients may have started non-VA psychotherapy 
after enrollment.  Finally, we will construct variables that indicate if the Veteran received any in-person 
psychotherapy (y/n), completed an adequate trial of any psychotherapy (y/n), received any evidence-based VA 
psychotherapy (y/n), and completed a trial of evidence-based VA psychotherapy (y/n).  
 
Generalized Anxiety Disorder 7 item scale (GAD-7). The GAD-7 total score ranges from 0 to 21, with “cut 
scores” for mild, moderate and severe anxiety.  Although originally developed for generalized anxiety disorder 
symptoms, the GAD-7 has good operating characteristics for detection and severity ratings of panic disorder 
and social anxiety disorder.(117) 
 
The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool that evaluates suicidal 
ideation and behavior. The C-SSRS has good validity with other scales of suicidal ideation and behavior, and 
sensitivity to clinical change (Posner et al., 2011).  
 
State Hope Scale is an internally consistent 6-item measure that asks respondents to select a number 
between 1 (Definitely False) and 8 (Definitely True) that represents how they think about themselves at the 
time of the assessment.  The SHS total score ranges from 6 to 48 with higher scores being indicative of greater 
levels of hope. The scale has demonstrated good internal consistency and validity.(81) Variations of this scale 
have been used in studies of peer-led interventions for persons with mental health conditions and have shown 
positive change.(82) Positive change on this scale was also found in our pilot work. 
 
Treatment Stigma is a 4-item Likert scale measure derived from the Self-Stigma of Depression Scale 
(SSDS), which consists of 16 items and four subscales (Shame, Self-Blame, Help-Seeking Inhibition, and 
Social Inadequacy) and has been shown to have high internal consistency (Cronbach’s alpha = 0.87) (Barney 
et al., 2010).  
 
Working Alliance with Peer is an 8-item Likert scale measure developed for this study in order to assess 
participants’ therapeutic alliance with their peer mentor.  
 
 
 
E.9.c Potential Mediating Variables : Below, we note potential mediating variables for the impact of PS-
cCBT on patient outcomes, including depressive symptoms and functional status.  Some of these proposed 
mechanisms may result from the cCBT core content (for example, CBTSQ) while others may result primarily 
from supportive contact with the peer specialists (ISMI) or from both components of the intervention (PAM-
MH). However, in this study, we will not attempt to separate the impact of the two components of PS-cCBT.  
 

E.9.d Other Covariates  
Demographics: Patients age, gender, reported race/ethnicity, educational level, and marital status will 
be obtained in the study-specific questionnaire. 
Primary Care Provider Mental Health Activity: Primary care clinicians may differ in their interest in and 
their level of activity in treating depression among their patients. Patients who are treated by primary care 
clinicians who actively diagnose and treat depression might receive more active depression management 
(more monitoring, referrals, and more medication starts and changes) than patients who are treated with 
clinicians who are less active in depression care. Therefore, we will construct a measure of primary care 
clinician depression care activity and include this measure as a covariate in study analyses.  Using provider 
code, we will determine primary care provider antidepressant prescribing patterns (calculated as the number of 
antidepressant fills written by PC clinician divided by the number of patients seen by the clinician in the prior 
FY). We will also construct a variable for PC clinician diagnostic patterns (calculated as the number of patients 
who have a psychiatric diagnosis noted in an encounter by the clinician divided by the number of patients seen 
by the clinician in the prior FY). 
Receipt of Other Health Services: We will also use VA administrative data to assess the numbers of VA 
primary care outpatient visits, VA specialty medical or surgical visits, emergency department visits, VA medical 
or surgical hospitalizations, and VA psychiatric hospitalizations.  Our team has had considerable experience 
using administrative data to assess all of these types of health services use, and careful description of all care 
received is necessary when an intervention is added to usual care and a EUC control is used.(64) 
Out of VA health care use will be assessed with the Cornell Service Index (CSI). The CSI was 
developed to assess the frequency and duration of use of a range of health services over the past three 
months. (85)The CSI has good inter-rater reliability with ICC for the global indices ranging between 0.97 to 1.0. 
Test-retest data generated Pearson correlation coefficients of 0.93 for psychiatric outpatient care and 0.83 for 
all visits combined.(85)  
Psychiatric and Substance Use Comorbidities. Psychiatric comorbidities may have implications for the 
success of the PS-cCBT intervention. We will include dichotomous indicators for the presence/absence of 
PTSD, another comorbid anxiety disorder, Bipolar II, or a comorbid personality disorders in study analyses. 
These comorbidities will be ascertained from medical records for the 12 months prior to enrollment. Although 
patients with severe substance use disorder will not be included in the study, we will assess potential 
hazardous alcohol use and non-dependent substance use.   
General Medical Burden will be measured using a modified version of the Charlson Co-morbidity Index, 
constructed from medical record review.    
The Interpersonal Support Evaluation List (ISEL)-12 is a shorter 12 item version of the ISEL, including 
the subscales of “appraisal”, “belonging”, and “tangible” support. Each item is rated on a four point Likert-type 
scale in which the subject indicates whether statements about social activities are definitely true, probably true, 
probably false, or probably true.  The “tangible” subscale assesses the perceived availability of material aid; 
the “appraisal” subscale examines emotional support; and “belonging” subscale assess opportunities for 
shared activities. Various versions of the ISEL have demonstrated excellent reliability, validity, and internal 
consistency in both general and psychiatric populations. (86) 
Distance to the VA service site:  Distance/travel barriers may make affect the uptake and use of formal 
mental health services for depression. (87) We will assess the number of miles from a patient's residence to 
their nearest VA source of care.  
Computer Literacy: Computer literacy may serve as a barrier to use of a computerized CBT program; 
therefore, a study-specific, 8-item measure of computer literacy will be collected to assess participants’ comfort 
level with using a computer and internet applications, as well as how frequently they use these tools.  
 
E.10 Schedule and Content of Study Assessments 
We have attempted to keep the burden of study assessments within reason, deliberately choosing 
some shorter measures of important constructs, if possible. (For example, we use the GAD-7 rather than the 
BAI for measurement of anxiety because of its shorter length.)   The estimated times for study assessments is 
approximately 50-60 minutes, based on published questionnaire administration times and the use of the 
general rule of 5 closed-ended questions or 2 open-ended questions per minute.  
The Interpersonal Support Evaluation List (ISEL) will only be administered at baseline and several 
covariates will be assessed using chart and administrative data, reducing patient burden.  
 
 

Study Measures for Patient Completion 
Screening Baseline  12 weeks 
24 weeks 
Screening Measures 
Patient Health Questionnaire (PHQ-9) 
X 
 
 
 
Computer Literacy (study specific questions) 
X 
 
 
 
Primary Outcome Measures 
Inventory of Depression Symptoms – Self Report (IDS-SR) 
X 
X 
X 
Veterans RAND 12-Item Health Survey (VR-12) 
X 
X 
X 
Quality of Life Enjoyment and Satisfaction Questionnaire 
X 
X 
X 
Recovery Assessment Scale (RAS) 
X 
X 
X 
Secondary Outcome Measures*/ Many also Mediators 
 
 
 
Depression Coping Self-Efficacy Scale (DCSES) 
X 
X 
X 
Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) 
X 
X 
X 
Adherence with Antidepressant Medications (MPR* and BMQ) 
X 
X 
X 
Receipt of Traditional In-Person Psychotherapy  
X 
X 
X 
State Hope Scale (SHS) 
X 
X 
X 
Patient Activation Measure 
X 
X 
X 
Internalized Stigma of Mental Illness (ISMI)  
X 
X 
X 
Working Alliance with Peer Specialist (study specific 
questions) 
 
X 
X 
Generalized Anxiety Disorder -7 (GAD-7) 
X 
X 
X 
Beck Scale for Suicidal Ideation (BSS) 
X 
X 
X 
Other Covariates 
 
 
 
Demographics 
X 
 
 
Alcohol use (AUDIT-C) 
X 
X 
X 
Primary care provider mental health activity* 
X 
 
 
Concurrent health services use (VA administrative data* and 
CSI) 
X 
X 
X 
Mental health and substance use comorbidities* 
X 
 
 
General medical burden* 
X 
 
 
Baseline social support (ISEL) 
X 
 
 
Distance to VA facility (calculated by staff)* 
X 
 
 
*calculated by staff, no burden on patient 
 
 
E.11 Study Analyses 
 
E.11.a Analyses of Success of Randomization: We will first determine the success of the randomization 
process for potential prognostic factors that may affect the primary outcomes of severity of depressive 
symptoms and functional status, but were not considered in minimization scheme.  These factors include 
variables such as prior hospitalization or baseline severity of anxiety symptoms. Potential differences between 
groups will be determined through the use of t-tests or chi-square analyses, as appropriate.  When there are 
significant differences in the distribution of these variables, they will be included as covariates in multivariable 
analyses.  The interpretations of final results will also be made carefully in the presence of significant baseline 
differences. 
E.11.b Analyses Relevant to Primary Aims: Primary study analyses will determine the effectiveness of the 
PS-cCBT intervention in decreasing depressive symptoms (IDS-SR), improving functioning and quality of life 
(VR-12, Q-LESQ-SF), and increasing recovery focus (RAS) at 24 weeks post-enrollment.  We will also 
examine the impact of the intervention on depression coping efficacy and skills, antidepressant adherence, and 
initiation and completion of traditional in-person psychotherapy (contingent on symptoms). 
 
Analyses will be of two broad types, those that assess intervention effects at each assessment point (12 
weeks and 24 weeks), and those that determine effects over time. Primary analysis will be based on “intent to 
treat” principle, with all randomized patients included in the originally randomized group, regardless of whether 
they have subsequently dropped from their assigned treatment group.  
 
Univariate Analyses: In the first phase of analysis (data verification), we will examine the distribution of 
all study variables to assess extreme values, missing data, variances, possible coding errors, skewness and 
whether or how to categorize skewed data.  We will then describe means (±SD) for the continuous IDS-SR, 
VR-12, Q-LES-Q-SF, and RAS measures by study group for each assessment time for the entire sample and 

for each of the study sites, separately.  
 
Bivariate/Multivariate Analyses: We will evaluate bivariate associations between patients’ treatment 
condition (PS-cCBT versus EUC) and the study outcomes to determine unadjusted measures of effect. We will 
also examine bivariate relationships between each of the potential covariates and the outcomes, and between 
each of the potential covariates and intervention group to assess possible confounders.  Bivariate relationships 
between potential covariates will also be assessed for any collinearity in subsequent analyses. 
 
Independent (Predictor) Variables 
Dependent (Outcome) Variables  
Treatment Group   
PS-cCBT vs Usual Care 
Potential Covariates  
Demographics 
Baseline measures of outcome variables  
Psychiatric comorbidities 
Study Site 
Social Support Prior to Enrollment 
General Primary Care Clinician Level of Depression 
Treatment Activity 
Distance to nearest VA facility 
Primary Outcome Variables 
IDS-SR 
VR-12 
Q-LES-Q-SF  
RAS 
 
Secondary Outcomes *  
Depression Coping skills (DCSES, 
CBTSQ) 
Antidepressant adherence 
Traditional psychotherapy use 
(contingent on symptoms) 
Hope 
Patient activation 
Anxiety 
Suicidal Ideation 
 
 
* please note some secondary outcomes 
may be considered mediators in other 
study analyses 
 
 
 Effects At Each Assessment Time:  Comparison at 24 weeks post-enrollment will be our primary 
comparison, but we will also assess patient outcomes to acute effects of the PS-cCBT intervention at 12 
weeks.  We will first obtain unadjusted differences in the outcomes between the two study groups with its 
associated 95% confidence interval.  Comparisons of primary outcomes (IDS-SR, VR-12, Q-LES-Q-SF, RAS) 
between treatment groups at each assessment time will be accomplished using multiple regression models.  
Multiple regression models for each outcome variables will include the baseline values of the outcome variable 
as covariates to adjust for baseline differences, making the model analogous to analysis of covariance.  We 
will also include two dummy variables for three sites and adjust for additional baseline covariates that show 
baseline imbalances in bivariate analyses.   
 
Effects over time: We will next compare the effects of the PS-cCBT intervention versus EUC over time. 
This second set of analyses will use linear mixed-effects model with outcomes at all three assessment times as 
the response variable.  The mixed-effects model will include patient as random intercepts to take into account 
the correlation of data within person over time. The model will allow the full use of all observed data despite 
missing outcomes at one or two assessment times and will give unbiased estimates as long as the 
missingness does not depend on the unobserved missing data (missing at random).   
 
Using this model, we will be able to estimate the time-averaged effect of the intervention if the response 
to the intervention is immediate and lasting, or compare the rates of changes in the outcomes between the two 
groups if the outcomes show different trends between the study groups.  Whether we compare the time-
averaged effects or the rates between two groups, we will be guided by careful graphical exploration of the 
longitudinal data over time between the two groups.  For example, if we find scores from IDS-SR to slowly 
decrease over time in the intervention group, but to slightly increase in the enhanced usual care group, we will 
model this by including a continuous time indicator (e.g., month since randomization) and a time by 
intervention group term in the model. The coefficient from the interaction term will estimate the difference in 
rates of change in outcomes between the two study groups.  
 
 
 
E.11.c Secondary Outcomes:  Analyses of secondary outcome of Depression Coping Skills and 
antidepressant medication adherence will proceed as outlined above for the primary outcome variables. For 
analyses of receipt of VA and non-VA traditional in-person psychotherapy, we will compare the percent 

initiating traditional psychotherapy between 12 to 24 weeks in patients in PS-cCBT versus EUC who have 
continued significant depressive symptoms at 12 weeks, defined as IDS-SR >16. The likelihood of initiation of 
traditional psychotherapy by 24 weeks will be compared using logistic regression model.  As patients in need 
of continuing treatment at 12 weeks from the two groups are likely to differ, the model will be adjusted for 
variables that show meaningful differences between groups at 12 weeks. Although completion of a traditional 
therapy trial will be of interest, our primary interest here will be to see whether PS-cCBT increases the 
likelihood that Veterans would initiate a traditional therapy.  
 
E.11.d Secondary Aim: Mediation of Intervention Effects on Symptoms, Functioning, QoL:  We will 
examine whether any improvements in the primary outcomes of depressive symptoms, quality of life, functional 
status, or recovery focus are mediated through increased medication adherence or increased depression 
coping skills. To test whether a variable might be a mediator, we will first test the associations between the 
intervention and the mediator, and then the mediator and the outcome of interest using bivariate analyses. A 
variable will be considered a potential mediator if the variable is associated with both the intervention and the 
outcome in these analyses (i.e., as determined by a significance level of P<.10), and changes in the mediating 
variable occur prior to changes in outcomes.  
           Finally, for primary outcomes, such depressive symptoms at 24 weeks, we will additionally include the 
change in depression coping score from baseline to 24 weeks and/or change in antidepressant adherence 
from baseline to 24 weeks.  If, as hypothesized, the intervention’s effects on the primary outcomes are 
mediated through changes in depression coping or increased antidepressant adherence, the variance in 24 
week symptoms explained by the intervention group will be less once the depression coping scores and 
antidepressant adherence are taken into account.  We will also consider change in depression coping score 
from baseline to 12 weeks and/or antidepressant adherence at 12 weeks as potential mediators as the early 
effect of intervention on these variables may have affected the 24 week outcome. 
 
 
E.11.e Planned Exploratory Subgroup Analyses: In addition to our primary comparisons of quality of life, 
and functional status, we will explore whether the peer-support intervention is differentially effective in specific, 
identifiable subgroups of patients, including those with more or less severe depression and those who have the 
primary care clinician with higher versus lower level of general activity in the management of their depressed 
patients. 
We hypothesize that: a) Benefit from PS-cCBT will not be associated with initial severity of depressive 
symptoms and b) Patients will benefit more from PS-cCBT than usual care if their primary care physician is 
less active in depression treatment.  
 
Univariate Analyses: We will describe the frequencies of patients reporting mild, moderate, or severe 
depressive symptoms.  We will also describe either the frequencies of patients who have primary care 
physicians who are more rather than less active in depression care or the mean and standard deviation of the 
primary care provider depression care activity measure based on the number of antidepressant fills written by 
the primary care provider divided by the number of patients seen in the prior FY by the provider.  
 Bivariate/Multivariable Analyses:  To explore the differential effectiveness of the PS-cCBT intervention 
among these patient subgroups, we will extend the model to include potential moderators of the intervention 
effect. For example, in addition to treatment group and other covariates, we will now stratify the analysis by the 
categories of baseline depressive symptom severity. If there is an observed differential effect (e.g., intervention 
effects are larger for patients with moderate or higher levels of depression symptoms than those with mild 
symptoms), then the differential effect of the PS-cCBT for these subgroups will be more formally assessed by 
adding in the main and interaction effects of the moderator (e.g., depressive symptom categories) and the 
intervention group. Assessment of whether the effects of PS-cCBT depend on the primary care provider’s level 
of depression management activity will be carried out in similar fashion.  Because subgroups are being 
considered, we may have limited power to detect differential effects of the intervention unless the interaction is 
large, and at the same time, due to the limited power, we may find that benefit from PS-cCBT does not depend 
on baseline severity of depressive symptoms. Therefore, these analyses will be exploratory and focused more 
on identifying trends rather than inferential testing.    
E.12  Approach to Missing Data: Our initial analyses will only use observed data. We will check if 
missingness depends on covariates and will include those covariates in the models described above. However, 
we will conduct a second analysis that imputes missing data. Specifically, we will impute missing data using 
the method described by Lavori, Dawson, and Shera.(83) In brief, we will use logistic regression to model 
patients' likelihood of having specific outcome data and define strata within which outcome values are missing 

at random.  We will then stratify patients according to these propensities and randomly sample from the 
observed outcome distribution and impute values for missing data within each stratum.  When data are missing 
for items within scales, we will use recommended imputation procedures rather than deleting patients list-wise 
from the analysis.  
 E.13 Power Analysis 
         We propose to enroll 330 patients in total (165 per group).  The sample size was calculated to provide 
90% power to detect a difference in levels of depressive symptoms at the primary end-point of 24 weeks, 
conservatively assuming a mean effect size of 0.4 SD with a two-tailed alpha of .05 and 20% dropout.  We 
expect that this effect size is conservative based on the meta-analysis completed by Spek et. al.  The meta 
analysis of cCBT interventions for depression and anxiety found that RCTs of cCBTs for depression and 
anxiety with therapist support had a mean effect size of 1.00 SD, while unsupported cCBT had a mean effect 
size of 0.26 SD.  This suggests that we can reasonably expect our peer-supported cCBT to have an effect size 
in the range of 0.4 to 0.6 SD compared with enhanced usual care.  In another study, Titov et al, reported an 
effect size of 1.1 from a technician supported cCBT for depression.  In our pilot work, congruent with reported 
effect sizes in the literature in other populations, we found that depressive symptoms among Veterans with 
depression enrolled in BTB were reduced by 27%, with a mean BDI-II of 21.9 (SD=11.1) at baseline and 16 
(SD=13.5) at 8 weeks.  Although the pilot study did not have a control group and the endpoint was at 8 weeks, 
the effect size estimated based on changes from baseline to 8 weeks can be considered to range from 0.43 
SD (with an assumed SD of 13.5) to 0.53 SD (an assumed SD of 11.1).  Thus, based on the meta-analyses 
and our pilot data, we consider a between-group difference of 0.4 SD a clinically meaningful and detectable 
effect size for the proposed intervention.  We also note that for the analysis using longitudinally measured data, 
the power will also depend on the within-person correlation.  The proposed sample size, however, will likely 
give greater power than 90% if 0.4 SD is the time-averaged between-group difference.   
 
For the secondary outcome of rate of initiation of a traditional psychotherapy, assuming that at 12 weeks, 
50% and 65% of patients in the PS-cCBT and the enhanced usual care groups, respectively, could benefit 
from more intensive intervention and further conservatively assuming that 20% will drop out by 12 weeks, we 
expect the proposed number of enrollees with less than full response will be approximately 66 in the PS-cCBT 
group and 86 in enhanced usual care group. With these expected numbers of patients in need of more 
intensive treatment at 12 weeks, we will have 63% power to detect the difference of 55% initiating a traditional 
therapy in PS-cCBT group vs. 35% initiating a traditional therapy in the enhanced usual care group, and 80% 
power to detect the difference of 59% initiating a traditional therapy in PS-cCBT group vs. 35% base rate. 
 
F.  DISSEMINATION/IMPLEMENTATION   
We will disseminate the results of this project through usual channels such as journal publication and 
presentations at conferences.  Dr. Valenstein has regular contact with members of the VA Mental Health 
QUERI and both Drs. Valenstein and Pfeiffer are part of the QUERI Recovery – Peer Support working group. 
Drs. Valenstein and Pfeiffer regularly apprise this group of team progress in peer related research. One of the 
operational letters of support comes from Mr. Dan O’Brien-Mazza, the National Director of Peer Support 
Services. He also regularly attends the QUERI-Peer Support working group calls and will receive regular 
updates throughout the course of the trial. 
Dr. Valenstein and Pfeiffer have offices that are co-located with the Primary Care-Mental Health 
Integration (PC-MHI) implementation and the PC-MHI evaluation team. Thus, they have regular contact with 
Drs. Post and McCarthy who lead and evaluate efforts to improve integration of mental health services into 
primary care settings, respectively. This proposal has been discussed with Dr. Edward Post who wrote an 
operational letter of support and gave several suggestions regarding how to make this proposal relevant to 
primary care services in the VHA. 
Team members also regularly communicate with both the VHA Office of Mental Health Operations and 
VHA Office of Mental Health Services.  If we find that the intervention leads to improved outcomes, we will 
seek partnerships to explore how the intervention can be more widely implemented throughout the VA.  
If the trial is positive, we have discussed with Dr. Dan O’Brien-Mazza the option of adding an appendix to 
the existing VA peer-specialist manual that describes the structure of PS-cCBT intervention and outlines the 
protocol for peer specialist involvement as supporters of this treatment option.  
 

G. Data Management  
Study assessment will be administered online through Qualtrics, a University of Michigan research partner that 
meets HIPAA privacy standards. The Qualtrics website is password protected and hosted on a secure server. 
Participants will be referred to Qualtrics terms and conditions of use during the informed consent process and 
upon opening each of the study assessment batteries.  Participants who have provided consent will enter their 
own personal information and no VA data will be transmitted to Qualtrics.com. Each participant will be given a 
code number.  The link between the names and code numbers will be encrypted and stored behind the VA 
firewall.  All patient consent forms will be kept in a locked cabinet. The administration of all study assessments 
will be conducted and monitored by the study staff through a password-protected Qualtrics.com 
account.  Research data collected through the survey will be stored on the Qualtrics.com server and will be 
purged weekly and uploaded to a secure VA-maintained data file. Confidentiality will be protected by restricting 
access to the research data to authorized study personnel only.  In particular, data will be stored on dedicated 
servers and in study folders that can only be accessed by specified study personnel. Qualtrics has been used 
in several VA Center for Clinical Management research projects without incident.