RCT of Behavioral Activation for Depression and Suicidality in Primary Care
Phase: NA
Conditions: Depression
Sponsor: VA Office of Research and Development

 
 
 
Improving Mood in Veterans in Primary Care 
 
 
 
Health Sciences Research & Development Title: RCT of Behavioral Activation for Depression and 
Suicidality in Primary Care – IIR 14-047-1 
 
 
PI: Jennifer S. Funderburk, Ph.D.  
 
 
Co-PI: Wilfred Pigeon, Ph.D. 
VA Center for Integrated Healthcare 
 
 
VA Center for Excellence for  
Suicide Prevention 
 
Date Report Prepared: 2/28/19 
 
 

RESEARCH PROTOCOL 
 
Background 
Depressive symptoms are associated with considerable morbidity, mortality, and quality of life decrements5-6, 10-
11, as well as significant economic impact due to lost work days12, disability10, and increased healthcare 
utilization13. For instance, 14.3% of total healthcare costs within the Veterans Health Administration (VHA) are 
accounted for by depression14.  
Indirectly, depressive symptoms are related to a number of negative health behaviors, such as poor sleep15-16, 
weight gain17, smoking17, substance use18, and lack of compliance with medical regimens19.  Depressive 
symptoms are also related to a loss of quantity and quality of social support20, which is linked with increased 
risk for death21.  
Directly, the association between depression and medical morbidities is likely due to alterations in 
hypothalamic-pituitary-adrenal axis activity23 and elevated inflammatory cytokine levels24-25.which are intimately 
tied to morbidities including, for instance, risk for cardiovascular disease26-27. Taken together, the direct and 
indirect health consequences associated with depression make it the leading cause of disability in the United 
States28. 
Finally, there is a strong etiological link between behavioral disorders and suicide29 with depressive symptoms 
being one of the most common and important risk factors among Veterans for suicidal thoughts and behaviors, 
including completed suicides22. Approximately half of Veteran suicide decedents in a national cohort study had 
a history of one or more behavioral health disorders30.  In psychological autopsy studies approximately 90% of 
suicide victims had one or more behavioral health disorders during their last weeks of life31.   
Accordingly, sound delivery of evidence-based care for depression is a cornerstone of behavioral health care 
and an important element of comprehensive suicide prevention efforts32.  The need to integrate clinical 
services to treat behavioral disorders such as depression in primary care settings is an ongoing focus within 
the VHA42. Whether brief interventions for depression are effective and can also serve to reduce suicide 
risk remains to be fully established.   
Experience of Depressive Symptoms and Suicidality in VA Primary Care Settings 
Within the VHA, Patient Aligned Care Teams (PACTs) have been identified as the frontline providers 
responsible for implementing strategies to identify/treat depressive symptoms and screen for suicidal ideation 
(SI). Targeting PACT teams would seem to be critical, as depression prevalence rates of 29%3 have been 
found in primary care and a large percentage of Veterans report depressive symptoms are managed within 
primary care33. Similarly, the prevalence of SI in primary care settings is between 2.4-3.3%34 with a majority of 
patients who commit suicide experiencing depressive symptoms34-35 as well as being seen by a PACT provider 
within a month prior to completing suicide36. In fact, treating depressive symptoms in primary care is one of the 
few evidence-based practices for suicide prevention32. 
 
Recognizing the value of targeting the primary care setting and depression for Veterans’ overall health, the 
VHA has supported several mental health initiatives over the past 10 years. In 1998, the VHA mandated 
annual screening for depressed mood using the Patient Health Questionnaire-237-38 and Patient Health 
Questionnaire-939. This allows PACTs to easily identify patients with depressive symptoms and SI and follows 
recommendations to screen for depression among all adults aged 18 years and older40. Unfortunately, it is now 
evident that laudable strategies that succeed in improving identification of severe depressive symptomatology 
in primary care are not nearly as successful resolving depressive symptoms41.  
The Role of Integrated Primary Care and Mental Health Services 
In an effort to fully address this problem, the VHA mandated a national initiative in 2008 to integrate mental 
health services within all PACTs to improve communication and collaboration between primary care and 
mental health providers (MHPs), otherwise known as the Primary Care-Mental Health Initiative (PC-MHI42). 
Each VAMC primary care setting is mandated to integrate one or more MHPs to serve each PACT, who can 
provide assessment and brief treatment for a variety of mental health problems44. Currently, 82% (N=124) of 
VA primary care clinics have at least one integrated MHP43. In addition, each VAMC is also mandated to blend 
these services with a care management program, which are typically protocol-driven and diagnosis-specific 
interventions often serving to support the PACT’s interventions42. The integrated MHPs and care management 

programs are intended to result in a blended model of integrative care, which is collaborative and establishes a 
foundation for communication among providers about mental health issues.  
The Behavioral Health Laboratory (BHL44) and Translating Initiatives for Depression into Effective Solutions 
(TIDES45) are the two currently acceptable care management models within the VA, with approximately 56% of 
primary care clinics providing some form of care management services43. Both the BHL and TIDES target 
depressive symptoms; however, their efforts are usually complemented with services provided by the 
integrated MHP. For instance, the TIDES program involves the use of a depression care manager to help 
assess and monitor Veterans reporting symptoms of a Depressive Disorder (i.e., MDD or Dysthymia) for 6 
months to make sure the Veterans are receiving appropriate care from the PACT. This may include a referral 
to specialty care, a prescribed anti-depressant, and/or meeting with the integrated MHP45.  The BHL is a care 
management system typically telephone-based that provides structured comprehensive assessments for 
psychiatric disorders, including depression, and the option of ongoing assessment (i.e., “Watchful Waiting”) for 
patients reporting subthreshold symptoms of depression. The BHL and TIDES programs assess SI; however, 
neither care management program offers any specific treatment management program for SI within primary 
care44-45. Instead, they recommend immediate crisis intervention, if needed, and referral to more intensive 
mental health services than typically provided in care management protocols as clinically appropriate.  For 
patients recently started on an antidepressant, the BHL provides a “Depression Monitoring” protocol that 
includes the elements of “Watchful Waiting,” with additional questions targeted at the Veterans’ experiences 
with the antidepressant medication44. Depending on the Veteran’s preference and/or symptomatology, the BHL 
may also recommend that a Veteran receive services from the integrated MHP.  
Therefore, it is not surprising that depression is the most commonly referred problem seen by integrated VA 
MHPs in primary care and 3.5% of these patients also report SI4, 46 (see Relevant Empirical Studies). Thus, 
integrated MHPs fill a critical gap in health care. They help PACTs in collaboration with care 
management programs to effectively provide brief treatments to Veterans reporting a range of 
depressive symptoms, including those reporting subthreshold symptoms and those who may not be 
willing to seek mental health care services. Therefore, the goals within treatment are different than 
traditional specialty care settings. Ultimately, the goals are to decrease symptomatology and increase 
functioning. When necessary, it is also hoped Veterans who likely would be treated more effectively in 
specialty care will become more comfortable with a referral to specialty care after receiving a brief 
intervention, allowing the integrated MHP to serve as the bridge47.  
 
Challenges to Delivering Empirically Supported Treatments in Primary Care 
Pharmacotherapy and psychotherapy are the two treatment strategies recommended by the VHA for 
depression48. Although pharmacotherapy is a common treatment strategy used within the primary care 
setting49, alternative strategies are necessary because medication is not recommended for patients reporting 
lower levels of depressive symptoms50 and is not always the preferred choice depending on patient preference 
and/or side effects49, 51-52. For instance, van Geffen et al.53 reported that one in four patients prescribed an 
antidepressant never initiate treatment (i.e., take medication longer than 2 weeks). In addition, many 
antidepressants carry a U.S. Food and Drug suicide risk warning complicating their use in patients reporting 
SI54, although they do remain an important tool in the management of depression. 
On the other hand, long-term psychotherapy is not conducive to delivery in primary care.  Several empirically-
based brief psychotherapies for depression in primary care have been found to be effective55 and result in 
comparable outcomes to antidepressant medication56. Both brief cognitive-behavior therapy (CBT) and 
problem-solving therapy (PST), ranging from 6-8 sessions, have been found to have moderate effect sizes in 
reducing depressive symptoms in patients with Major Depression in primary care compared to usual care7-8. 
Unfortunately, in the few studies examining the range of depressive symptoms, such as minor depression and 
dysthymia, there is minimal evidence that these treatments are efficacious57-58 In addition, these studies either 
did not report or did not assess any changes on SI, or excluded those individuals reporting SI, so that their 
possible effect on SI above and beyond reducing depressive symptoms is impossible to determine. Another 
significant limitation to this research is that a majority of the studies have been conducted on middle-aged 
females8, limiting generalizability to other populations. Thus, there remains a health services research gap with 
respect to identifying, modifying and testing brief depression interventions in primary care.    
The most significant barrier to providing such empirically-based brief psychotherapies for depression 
in primary care is treatment duration. Both brief CBT and PST typically range from 6-8 sessions lasting 30-
50 minutes, with a median of 6 sessions8. This is in strong contrast to the typical session format used by MHPs 

in VA primary care settings, which is 1-5 sessions of 15-30 minute duration (4, 46; see Relevant Empirical 
Studies section). This actual practice matches the guidelines for integrated healthcare, which recommend that 
MHPs work towards a maximum of 4 sessions of 15-30 minutes duration47, 59. These authors suggest that the 
frequency and length of contact with patients be dictated by the severity and/or complexity of a patient’s 
symptoms/needs while striving to maintain open access thereby often resulting in sessions scheduled 2-3 
weeks apart47. Limited work has been undertaken to bridge this gap between recommended length and 
number of treatment sessions and existing intervention formats, especially as it relates to providing 
evidence-based depression treatments. 
The ease of implementation of these other two efficacious brief psychotherapies (i.e., CBT or PST-PC) within 
real-world clinical settings is also yet to be determined. Although, they have been implemented by a range of 
healthcare professionals, researchers have provided little information about the training required or supervision 
necessary for implementation by various healthcare professionals8. In addition, these interventions (CBT and 
PST-PC) typically have involved healthy individuals without co-morbid medical problems, and involve 
challenging skills, such as effective problem solving or cognitive reframing.  
Behavioral Activation: A Good Candidate for Primary Care Based Depression Treatment  
Rooted in behavioral theory and initially a component CBT, behavioral activation (BA) was identified within a 
dismantling study as effective at reducing depressive symptoms on its own60, with no differences from 
traditional CBT at 2-year follow-up61. BA focuses on reducing depressive symptoms through the use of values 
assessment and activity scheduling. A core symptom of depression is the lack of interest or pleasure in most or 
all activities and activity levels overall have been found to be lower in patients with Major Depressive Disorder 
compared to normal controls62-64. Therefore, BA is designed to engage depressed patients in activities that 
provide more enjoyment and meaning65; thereby increasing the patient’s level of reward from experiences66 
and activity levels67.  
Recent work supports the traditional format of BA (i.e., ranging from 7-20 50-minute sessions) as an 
efficacious treatment for patients reporting severe depressive symptomatology, with effect sizes similar to other 
psychological treatments (d = .78-.879, 68). BA also is an efficacious alternative to psychopharmacology69-70. A 
5-12 session version of BA, called Brief Behavioral Activation Treatment for Depression (BATD71), has also 
been found to reduce depressive symptoms67, 72.  
BA is also effective at reducing depressive symptoms across a broad range of intensities (i.e., 
moderate-severe depressive symptoms) and with a diverse age-range of patients (i.e., younger college 
students to older adults9, 68). Demonstration of BA’s effectiveness in reducing depressive symptoms has 
included a number of population samples that are typically “difficult” to treat, including patients who have 
significant psychiatric and substance use comorbidities66-67, those with medical problems such as cancer73-74 
and obesity75, and those who are cognitively impaired76. In addition, BA may help improve overall quality of life, 
such as general well-being, increased social support, and reduced bodily pain77. Significant within the Veteran 
population is that preliminary research has found that the traditional format of BA is effective toward reducing 
symptoms of PTSD15, which helped create the foundation for a currently-funded VA Request for Applications 
for PTSD treatments for OEF/OIF Veterans78 (Jakupcak; PI). 
A recent meta-analysis concluded that there is too limited empirical work to ascertain whether depression 
psychotherapies impact SI, although their impact on hopelessness was deemed to be moderate to large123. 
Two large depression trials for older adults (not included in the meta-analysis) found that among those who 
endorsed SI at baseline, 90% continued to have SI following treatment-as-usual compared to 50% following 
depression treatment 124,125. We are not aware of any controlled trials of BA that report its effect on SI. In one 
uncontrolled study, however, preliminary results in a sample of 32 depressed breast cancer patients suggest 
that patients who received BA experienced significant reductions in SI and significant increases in hopefulness 
at post-treatment, which  were maintained at 12-month follow-up (D. Hopko personal communication, May 6, 
2013). While speculative, it is conceivable that with its focus on increasing pleasurable activities (and, to some 
extent, social engagement) BA can reduce suicidality by increasing reasons for living, quality of life, and 
enjoyment in life.  
Similar to other brief psychotherapies for depression, there is a lack of rigorous studies examining BA 
or BATD in the format consistent with what MHPs use in primary care (i.e., 4 or less 15-30 minute 
sessions). A naturalistic study conducted within a VA integrated primary care setting demonstrated that 2-4 
sessions of BA reduced depressive and anxiety symptoms among depressed Veterans at posttreatment and 
one month posttreatment79. Others have shown that a one-session version of BATD was effective at reducing 

depressive symptoms in moderately depressed university students compared to controls80; however, they did 
not use a clinical sample.  In addition, an uncontrolled study of brief BATD (approximately 6 20-minute 
sessions) found BA to be effective in reducing depressive symptomatology in inpatient psychiatric patients72. 
What remains to be established is whether a brief form of manualized BA delivered in a primary care 
setting leads to clinically significant benefits compared to clinical services already provided.   
Research examining the efficacy of BA has found small to moderate effect sizes at follow-up compared to post-
treatment, suggesting that the effects of BA on depressive symptoms can be lasting. However, follow-up 
periods have varied across the studies, ranging from one-month to two years9, 68, 79. Because MHPs working 
within primary care settings provide brief interventions to patients who can be reluctant/resistant to engaging 
within outpatient specialty care, identifying interventions that can reduce depressive symptoms over the long-
term is ideal. Other studies examining brief psychotherapies within primary care also significantly vary their 
follow-up periods; however, the modal follow-up period that studies report is one-year55.  
Summary  
The high prevalence of depressive symptoms among Veterans in VHA primary care practices coupled with the 
necessity of delivering (but paucity of existing) effective brief interventions in these settings provides a strong 
rationale for the proposed study. MHPs working with PACTs need to have evidence-based interventions that 
meet the needs of their clinical practice, improve the quality of life for Veterans, and help engage those 
Veterans initially reluctant to mental health care.  These interventions need to be versatile enough to be 
effective with Veterans reporting a range of depressive symptoms and/or medical complexities. BA is ideally 
suited for modification to the primary care setting due to its: 1) focus on behaviors (similar to other self-
management focused interventions in primary care) allowing for easy application with a range of Veterans, 
including those with co-morbid psychiatric or physical problems, 2) ease of adaptation to each Veteran 
depending on unique individual factors including psychosocial variables, 3) the uncomplicated skills required to 
understand and implement BA71 with a recent study showing a 12-session BA protocol could effectively be 
delivered by mental health nurses using a 5-day training and supervision82, 4) evidence supporting its use with 
a range of depressive symptoms and patient populations compared to CBT or PST-PC, 5) research showing 
that BA may help reduce symptoms of PTSD by breaking patterns of avoidance, 6) drop-out rates that are 
lower than CBT81, 7) preliminary evidence that BA may reduce SI in patients reporting SI (D. Hopko personal 
communication, May 6, 2013), and 8) research indicating patients receiving BA improve at the same rate as 
those prescribed an antidepressant and improve significantly more per treatment week than those in cognitive 
therapy70. 
Methods 
Design Overview  
The proposed study is a single blind randomized, controlled trial 
(N=144) with two conditions (4-session BA-PC or TAU) that 
uses an intent to treat design. Following an initial telephone 
assessment session, all patients who agree to participate and 
who meet all inclusion criteria will be asked to participate in the 
study. As depicted in Figure 2, all Veterans will complete a 
baseline assessment. Eligible Veterans will be randomized in 
equal proportions to one of two conditions (4-session BA-PC or 
TAU). All Veterans will complete biweekly brief telephone mood 
assessments for the first 12 weeks. These brief biweekly 
assessments can also be completed in-person, if they align with 
another assessment or if the participant prefers to meet in-
person. Comprehensive assessments will occur at 6 weeks and 
12 (post-treatment), as well as at 24 weeks. After 12 weeks (post-treatment), all participants will be allowed to 
seek additional psychological treatment, if desired. 
Settings 
This study will be implemented in four different primary care clinics in VISN 2 (Syracuse VAMC, Canandaigua, 
Buffalo VAMC’s, and Rochester Outpatient clinic). We will seek Buffalo IRB approval as well.  
Study Population  
Power analyses revealed that a total of 144 Veterans (72 Veterans per group) will need to be randomized to 
provide 80% power to detect a medium effect of the intervention on depressive symptoms at the 12-week post-
 Figure 2. Design Overview  
Baseline Assessment 
 
Biweekly 
 
Assessment 
 
4 BA-PC 
TAU 
Wk 12 Assessment (Post –Tx) 
Wk 24 Assessment 

treatment time point, while accounting for a 30% attrition rate across the 12-weeks. Using the previously 
collected data to give indication of our screening rates and rates of eligibility and consent to enroll in the trial, 
we expect to be able to recruit 4-5 eligible patients per month across a 33-month recruitment time period 
resulting in the ability to recruit approximately 165 Veterans. Ultimately, we would need to conduct telephone 
screens on approximately 335-379 depending on the specific eligibility (38%-43%) rate used from our 
preliminary study. 
Recruitment will occur using four methods: 1) Direct referrals from PACT team providers and staff, including 
integrated MHPs when meeting with patients who score positive on the PHQ-2 (> 2) or indicate symptoms of 
depression, 2) Referrals from the Behavioral Telehealth Center, a primary care service designed to provide 
telephone assessment of mental health concerns of primary care patients, of patients who report depressive 
symptoms as measured by the PHQ-9 and who indicate interest in hearing about research studies, 3) Flyers 
within primary care clinics waiting rooms for interested patients experiencing depressed mood, 4) Following a 
primary care provider’s approval, communication via letters sent to primary care patients who have reported 
depressive symptoms during a recent appointment (identified via chart review) or who have scored positive on 
the PHQ-2 within the past month. These letters will describe the study and alert patients that a member of the 
research staff will be calling them within 1-2 weeks to ask about their interest in participating in a research 
study (see letters of support).   One of two methods will be used to identify patients with positive PHQ-2 
screens within the past month: 1) via an information technologist within VISN 2 who will pull this data (i.e., 
patient name, address, social security number, date of birth and telephone number) or 2) information will be 
requested and extracted from the VA Corporate Data Warehouse (CDW) and placed within VA Informatics and 
Computing Infrastructure (VINCI; see below for more information on the VINCI).  
Inclusion Criteria  
Initial Eligibility Screening: Veterans: a) aged ≥ 18 years, b) seeking or receiving primary care services at the 
Syracuse, Canandaigua VAMC’s and Rochester Outpatient Clinic; and c) reporting depressive symptoms by 
screening positive for depression on the PHQ-2 (> 2) are eligible. 
Baseline Assessment: Veterans: a) reporting at least moderate symptoms of depression, scoring greater than 
or equal to a 10 on the PHQ-9; b) who are either on a stable antidepressant dose for > 6 weeks or are not 
taking antidepressants, c) who have been receiving a stable course (i.e., regular scheduled sessions) of 
outpatient psychotherapy for anxiety disorders, including PTSD, or substance use disorders for ≥ 3 months,  
and d) who have had no more than one session with the integrated MHP discussing depression as this initial 
session tends to involve primarily assessment in past 4 weeks (see Relevant Empirical Studies) are eligible.  
Exclusion Criteria 
Initial Eligibility Screening: Veterans: a) unable to demonstrate an understanding of the informed consent by 
not being able to answer 5 comprehension questions; b) non-English speaking; and c) who are currently 
engaged in psychotherapy targeting depressive symptoms are ineligible. 
Baseline Assessment: Veterans who: a) are reporting imminent risk of suicide, as evidenced by the suicide 
assessment identifying the Veteran as imminent risk and in need of intensive treatment, such as 
hospitalization, b) have an unstable psychiatric condition (e.g., active psychosis or current mania) or who have 
a history of Bipolar I or II disorder and are in need of more intensive treatment; c) have recently started 
antidepressants or have not reached a stable dose (< 6 weeks); d) are currently receiving or currently 
completed (< 1 month) inpatient or intensive outpatient (e.g., partial hospitalization) programs for a mental 
health disorder and therefore currently engaged in significant mental health treatment likely targeting changes 
in mood symptoms; and e) who have recently started psychotherapy for an anxiety disorder or substance use 
disorder (< 3 months) are ineligible. 
Procedure  
To verify initial eligibility, Veterans will be asked to complete the PHQ-2 to confirm some level of depressed 
mood. Upon completion of the PHQ-2, Veterans will be asked a series of questions to determine whether they 
are currently engaged in any type of mental health treatment focusing on depressive symptoms. Because our 
recruitment methods will only initially identify Veterans who may be experiencing significant depressive 
symptoms and are not currently engaged in mental health treatment targeting depressive symptoms, this study 
will be conducted in two parts with two separate consent forms. The first part (Initial Eligibility Screening) will 
involve a brief initial telephone assessment, the purpose of which is to learn about the Veteran’s mood and 
current strategies he/she is using to improve his/her mood, including participation in treatment. If the Veteran 
meets the inclusion criteria for the second part of the study, then he/she will be asked to participate. If 

interested, the Veteran will be scheduled for an in-person baseline assessment session and will complete the 
second informed consent, which will describe the purpose of the study examining the effectiveness of a 4-
session BA intervention. See Table 1. If the Veteran is ineligible for the second part of the study because they 
recently started or changed medications, but interested in participating we will ask the Veteran if it is alright if 
we call them back in 3-4 weeks as research shows a large number of patients discontinue antidepressants 
before reaching 4 weeks. We will explain that as they have recently engaged in treatment or modified an 
existing treatment that this is not the best time to participate in a study. However, if they are interested, we 
would be happy to call them back and re-evaluate their eligibility after they have had several weeks to adjust to 
the treatment. When we call them back, we will have to re-administer the PHQ-9 and ask about his/her 
treatment/medication regimen to verify eligibility at that time. 
Initial Eligibility Screening 
The initial assessment will primarily occur over the telephone; however, any Veteran requesting to be seen in 
person can also complete the assessment during an in-person visit. During the initial assessment, patients will 
complete an informed consent process and then be asked to verbally complete: a) a demographics 
questionnaire, b) the Personal Health Questionnaire-9 (PHQ-9)39 assessing depressed mood, c) the MINI 
International Neuropsychiatric Interview modules for current mania and psychosis symptoms commonly used 
by the BHL to assess these same symptoms, and d) a medication and treatment history questionnaire 
assessing their history of bipolar disorder, engagement in treatment, and use of antidepressants.  
At the end of the screening session, research staff will review the various services available for all Veterans at 
their local VA. For those patients who are eligible to continue to the second part of the study, staff will also 
briefly describe the study. Research staff will facilitate a referral to any option chosen. All participants will be 
thanked for their time and will be sent $15 for completing this telephone assessment. 
Baseline Assessment (Week 0) 
Those patients who meet eligibility criteria and are interested in participating in the second part of the study will 
be scheduled for an in-person baseline assessment. Following informed consent and HIPAA waiver, research 
staff will confirm eligibility by examining the Veteran’s CPRS record to ensure that he/she meets eligibility 
criteria. 
As shown in Table 1, participants will be asked to complete self-report assessments, including those assessing 
mood, quality of life, SI, insomnia, and environmental reward from activities. Participants will be compensated 
$40 for completing the in-person session. 
Randomization 
Those participants eligible to continue in the study (based on CPRS review) will be called after their baseline 
appointment by a member of the research team to schedule their next in-person session based on being 
randomized in equal proportions to one of two interventions (4-session BA-PC or TAU) using a stratified block 
random assignment based on two factors: 1) “mild to moderate” (PHQ-9 score between 10-15) or “severe” 
(PHQ-9>15) depression and 2) presence or absence of SI (SSI≥1).   
Assessments 
All participants will be asked about depressive symptoms every two weeks for the first 12 weeks over the 
telephone or in-person. Participants will also be asked to complete more comprehensive telephone and in-
person follow-up assessments at 6, 12, and 24 weeks (as shown in Figure 1 and Table 1). During these 
assessments, participants will be asked to complete the same questionnaires as during the baseline 
assessment and several additional measures dependent on the assessment as identified in Table 1 focused 
on patient receptivity and medication/treatment history.  
All assessment sessions will be led by research assistants blind to condition and take place primarily (unless 
requested otherwise) via the telephone except the baseline, 12, and 24 weeks (see Table 1). The 12-week 
assessment will occur over the telephone if unexpected circumstances prevents the Veteran from being able to 
come in to the medical center. All research assistants will track any non-study care given to participants as that 
may be a potential confounding variable to our examination of treatment effect88. 
At baseline, 12, and 24 week sessions, information will be collected from the medical chart of each participant 
regarding his/her current medical problem list, medications, engagement with mental health care, including 
types of interventions that they may or may not have participated in during the study as monitored by the VA 
electronic medical record system.  

Treatment As Usual Condition 
TAU will involve the Veteran receiving an appointment with the integrated MHP at their primary care clinic. At 
this encounter, the MHP can choose to deliver whatever interventions they deem necessary. In addition, the 
MHP and Veteran can work together to identify whether and when they would like to meet again during the 12-
week period of the active portion of the study. As recommended by Freeland et al88, it is unnecessary to force 
the TAU condition to have the same amount of attention unless the purpose is to examine specific and 
nonspecific effects, which is not the case in this study.  
BA-PC Intervention 
Intervention Description. A revised 4-session BA-PC manual was created with the help of Dr. Hopko, one of 
the original authors of the Brief Behavioral Activation Manuals (see Appendix 4). BA-PC will focus on 1) 
providing feedback regarding his/her experience of symptoms of depression, including the severity; 2) helping 
the Veteran understand the theoretical foundation for BA, the research behind it, and why it will help reduce 
symptoms of depression; 3) identifying activities (or lack thereof) within the Veteran’s life that may be helping 
to maintain depressive symptoms as well as any current behaviors that might be eliciting positive 
reinforcement of depressive behaviors; and 4) identifying new value-based activities that may elicit positive 
affect within a variety of major life domains (e.g., family, physical, etc.).  
Patient Treatment Adherence. A fundamental component of BA is establishing specific measurable goals 
regarding his/her engagement in activities at the end of each session. Therefore, patient adherence to the BA 
intervention can be monitored by examining the proportion of the number of goals completed versus the 
number of goals identified as homework by the interventionist and patient at the end of each session. Then, 
individual patient adherence can be calculated for each session and overall patient adherence can be 
calculated for each intervention condition. These calculations will help us understand basic patient adherence 
to the modified brief forms of BA-PC, which will be used as an indirect reflection of patient receptivity. 
Therapists & Therapists Training. Advanced-level clinical psychology graduate students or Masters-level MHPs 
working as research assistants will implement the 4-session format BA-PC.  They will participate in a 2-day 
workshop to establish training in BA-PC led by Drs. Hopko and Funderburk. Each research assistant will have 
to demonstrate proficiency within a role-play of BA-PC, observed by Drs. Hopko and Funderburk. All BA-PC 
intervention sessions will be audio-taped and Dr. Funderburk will meet weekly with the research assistants to 
provide supervision of the BA-PC based on review of audio-taped sessions, session materials, and ad hoc 
supervision issues raised by research assistants. In addition, Dr. Hopko will also provide monthly telephone 
supervision regarding the implementation of BA-PC. 
Therapist Treatment Fidelity. To monitor high treatment fidelity within BA-PC and to ensure TAU has low 
fidelity to BA-PC, research assistants will audio-tape all sessions. For integrated behavioral health providers, a 
research assistant will come to the scheduled session with the audiotape recorder and then collect the 
recorder when the session is done. Research assistants will immediately download the files to the secure X: 
drive and delete them from the audio-recorders. In the event of audio-recorder failure or to accommodate 
behavioral health providers’ preferences, the provider would receive either a paper questionnaire (see 
Appendix 6) with a sealable pre-filled out envelope or an encrypted email with a link to fill out the questionnaire 
(see Appendix 6 for template email). No identifiable information will be included on the questionnaire. If the 
paper questionnaire is completed, providers will return it to research staff either in-person or via VA interoffice 
mail to research staff within the same VA location. Reminder emails will be sent to providers to help ensure this 
information is collected. The online document will be hosted on psychdata.com, which has a high level of 
security (see Appendix 6 for more details). The Principal Investigator, Dr. Funderburk, has used the 
psychdata.com server successfully for IRB-approved, secure online data collection in several prior studies 
(e.g., Veteran Treatment Preferences, Clinical Interventions Used by Behavioral Health Providers in Primary 
Care). Only de-identified data will be stored on the psychdata.com server, so there are no changes to the 
original Data Security Agreement. Data from the questionnaire will be downloaded on a weekly basis and 
saved on the secure X: drive. Independent raters, who have mental health training and are trained in BA-PC, 
will review the audiotapes and asked to complete a treatment checklist identifying what elements of BA-PC 
were present and how long the provider spent discussing them during the course of the session. This checklist 
will also incorporate items from the OPTION (Observing Patient Involvement) scale130, to assess for shared 
decision-making during TAU and BA-PC sessions. The Treatment Fidelity Checklist will be based on an 
established measure used for traditional BATD treatment fidelity74 and ask raters to report whether elements of 
other interventions commonly used in primary care (see Relevant Empirical Studies) are also discussed during 
the session (see Appendix 5).  Feedback will be regularly given to research assistants on ratings to ensure BA-

PC treatment fidelity. In the event of audio-recorder failure during BA-PC treatment sessions, research 
assistants will fill-out a version of the Treatment Fidelity Checklist. This version of the checklist will require 
research assistants to specify whether each session-specific element of BA-PC was present and to enter 
specific notes, in lieu of ratings, pertaining to each section of each session for which the document is used (see 
Appendix 7).  
Intervention Format. Using preliminary data and established guidelines on the typical formats of interventions 
MHPs can use in primary care, all interventions sessions for the 4-session BA-PC will be designed to be short 
(approximately 20-30 minutes) and occur approximately 2-3 weeks apart, mimicking the MHP’s schedule in 
primary care in an effort to maintain open access. Therefore, the first two BA-PC interventions should occur in 
the first 6 weeks and the second two should be both BA-PC interventions should be completed by the 12-week 
assessment. All interventions are designed to be conducted in person; however, they will be conducted over 
the telephone if the Veteran experiences an emergency making it difficult for them to travel to the VA (e.g., 
snowstorm, car troubles). This follows the typical approach integrated behavioral health providers use if a 
Veteran would like to continue to meet. As this will not be the primary format and will only be used in rare 
occasions, it will not be included in the informed consent. 
Measures 
Table 1 summarizes the assessment time points and measures included. 
Initial Screening Telephone Assessment: 
Participants’ Background Information will be collected using the Demographic Questionnaire that will 
ask participants to report on information such as: age, gender, race, educational background, occupational 
status, etc. 
Medication and Treatment History will be collected using a self-report questionnaire that was modified 
from the Behavioral Health Laboratory’s core assessment44 to assess the Veteran’s past and current 
engagement in VA and non-VA outpatient specialty care services, including psychopharmacological 
treatment for mental health symptoms, including depression. In addition, it will ask the Veteran about 
current strategies for improvement of mood. It will be used to determine initial eligibility. 
It will also be given at multiple assessment time points to monitor engagement in treatment at 12 and 24 
weeks.  
Depressive Symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9)92, which is a 
9-item self-report questionnaire that assesses the frequency of depressive symptoms over the past two 
weeks with a specific focus on the symptoms necessary to meet criteria for DSM-IV diagnosis of Major 
Depressive Disorder. Individuals scoring 10 or above are identified as experiencing moderate symptoms, 
and those scoring 15 or above are identified as experiencing severe depressive symptoms92. Kroenke, 
Spitzer, and Williams found the PHQ-9 to be both reliable and valid in a sample of 6,000 patients in 8 
primary care clinics and 7 obstetrics-gynecology clinics92. The total score of the PHQ-9 has also been 
used as indicative of depression severity and is sensitive to clinical change92. It will be used to determine 
initial eligibility (i.e., inclusion criteria: Veteran scores > 10 on PHQ-9).  
It will also be given at the baseline assessment (week 0) to determine status for the stratified block 
random assignment. The PHQ-9 will also be administered at the other assessment time points as the 
primary outcome measure for depressive symptoms. 
Mania will be assessed using the MINI International Neuropsychiatric Interview modules for mania97, 
commonly used by the BHL to assess symptoms of bipolar. It will be used to determine initial eligibility 
eliminating those with current manic symptoms. 
Psychosis will be assessed using the psychosis portion of the DSM-IV Structured Clinical Interview98, as 
it is often identified as the “gold standard” for assessing psychosis.  It will be used to determine initial 
eligibility during baseline assessment. 
 
Week 0: Baseline Assessment: 
Suicidal Ideation Intensity will be assessed using the Beck Scale for Suicidal Ideation (SSI)99, which is a 
19-item interviewer-administered rating scale designed to assess current intensity of SI by asking about 

the patient’s specific attitudes, behaviors, and plans to commit suicide. The SSI has demonstrated high 
internal consistency and concurrent validity with the clinician-administered assessment among both 
inpatients and outpatients99. The SSI has been found to have moderately high internal consistency with 
Cronbach coefficient alphas at .89 and high interrater reliability with correlations at .98100. For our primary 
SI outcome, we will use the total score for the SSI as a continuous measure of intensity of SI.  
Quality of Life will be assessed through the use of two measures to assess various dimensions of quality 
of life and be used as our secondary outcome measures surrounding quality of life.  
The Short-Form-12 (SF-12)101 is a 12-item questionnaire that assesses an individual’s perceived health 
status with higher scores indicating higher perceived physical and mental functioning. Research has found 
high test-retest reliability and internal consistency101. The total score on the mental health functioning 
subscale will be used. 
The Quality of Life Inventory (QLI)102 is a 16-item self-report questionnaire that assesses life satisfaction 
across multiple domains in 16 areas (e.g., work, love, family, etc.). Participants are asked to rate items on 
a 3-point Likert scale indicating importance and satisfaction across each domain. Research has found it 
has a high level of internal reliability, construct validity, and validation within clinical samples103. Total 
scores range from -6 to +6 because total scores are calculated by averaging satisfaction ratings assigned 
nonzero importance ratings. The total score on the QLI will be used.  
Insomnia will be assessed using the Insomnia Severity Index (ISI)104, which is a widely used 7-item Likert 
scale that assesses sleep disturbances with items asking about difficulty initiating/maintaining sleep, 
daytime consequences, anxiety and satisfaction with sleep. It has found to be valid and reliable as a 
measure of sleep disturbance105. The ISI total score will be used as one of our secondary measures 
assessing subjective sleep outcome.  
Symptoms of PTSD will be assessed using the PTSD Checklist – Civilian version (PCL-C), which is a 17-
item questionnaire that assesses how bothersome participants have found a particular problem/symptom 
to be in the past month, using a 5-point scale.  Research has found it has good psychometric properties.127 
The PCL-C total score will be used as a secondary outcome measure assessing PTSD symptoms. 
Symptoms of Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), which is a 7-
item self-report scale that assesses the frequency of restlessness, worrying, and other symptoms of 
anxiety over the past two weeks. The scale has good reliability and construct, criterion, factorial, and 
procedural validity.128 The GAD-7 total score will be used as one of our secondary measures assessing 
subjective symptoms of anxiety. 
Levels of Environmental Reward will be assessed using the Environmental Reward Observation Scale 
(EROS)106, which is a 10-item 4-point Likert scale that assesses the positive affect and reward associated 
with environmental experiences. It has been found to have strong internal consistency and test-retest 
reliability106. It is frequently used within studies examining behavioral activation since levels of 
environmental reward associated with activities is a focus of the BA-PC interventions. The total score on 
the EROS will be used as a secondary outcome measure.  
 
Brief Pain Inventory (BPI). The BPI (Cleeland, et al., 1994) is a widely used self-report measure that  
assesses pain intensity (e.g. severity, location, chronicity) and pain-related functional disability (e.g. work, 
relationships with others).  The BPI includes 11 items that can detect significant changes in pain severity  
in longitudinal analyses (Kroenke, et al., 2009).  The BPI has been widely validated, showing good  
reliability and construct  validity (Tan et al., 2004).   
 
Tobacco Use Questionnaire. This is a brief, 11-item questionnaire comprising an assessment of current 
smoking status, nicotine dependence via the Fagerström Test for Nicotine Dependence (FTND)131, and 
readiness to quit smoking. 
Biweekly Assessments 
       Depressive symptoms will be assessed using the PHQ-9 and item #9 will be used to assess suicidal  
       ideation for safety purposes. 
      Antidepressant Medication Changes will be assessed by asking the Veteran whether he/she is    

      continuing to take the specific dosage of the antidepressant medication daily they reported taking at  
      baseline. If not, information will be gathered to identify whether they have decreased the medication,  
      stopped the medication, or increased the medication. 
6, 12, and 24 Week Assessments 
Treatment Satisfaction and Acceptability will be assessed with two instruments.  
The Client Satisfaction Questionnaire (CSQ)109 is an 8-item self-report questionnaire developed to assess 
patient satisfaction with medical and mental health treatment on a 1 to 4 Likert scale, with higher scores 
related to a higher level of satisfaction. For example, Veterans will be asked “How would you rate the 
quality of service you received?” on a four point scale ranging from poor (1) to excellent (4). Using the 
anchor points of the scale, each item needs to be rated a 3 or 4, yielding a total score of at least 24 or 
above to demonstrate a good level of satisfaction. The scale has a high degree of internal consistency and 
correlates highly with therapists’ ratings of perceived client satisfaction109.  Each item rating and the total 
CSQ score will be used to evaluate participants' satisfaction with the service (i.e., 4-session PC-BA and 
TAU). 
  
The BA Acceptability Interview is an 18-item interview that was designed for this study to assess the 
Veteran’s satisfaction with the specific components of the BA-PC intervention (including the patient 
education handouts), the acceptability of the intervention, and importance of each element of the 
intervention to the Veteran on a Likert scale. Open-ended questions will be used to elucidate additional 
comments about each Likert-scaled item. Veterans will also be asked to comment on the format of the 
intervention (i.e., length and number of sessions) and modality (in-person, internet, or telephone) for the 
primary care setting (see Appendix 5). This measure will be administered by the research assistant 
delivering the intervention at the last BA-PC session (to allow the assessment research assistant to stay 
blind to condition). It will be used to give us additional information on the acceptability of each component 
of the BA-PC intervention and collect information on future implementation. 
 
Treatment Engagement will be assessed using two variables collected via CPRS record review and 
supplemented by the Treatment History questionnaire: 1) number of BA-PC and TAU sessions will be 
summarized (both conditions will likely have a similar upper limit as BA-PC will optimally provide 4 
sessions and research on TAU suggests for those patients seen after an initial visit, the average number 
of sessions is 3) and 2) whether or not the participant had engaged in specialty care as assessed at week 
24. 
 
Therapeutic Alliance will be assessed using the Working Alliance Inventory (WAI)129. The WAI is a 12-
item self-report measure that assesses three different domains of the therapeutic alliance, including 
agreement on therapeutic tasks, agreement on goals of therapy, and development of a therapeutic bond.  
 
Table 1. Schedule of Assessment Measures 
 
Time (weeks) 
 
0 
2 
4 
6 
8 
10 
12 
24 
SUBJECTIVE ASSESSMENTS 
P 
T 
T 
T 
T 
T 
P 
T 
1. 
Symptoms of Depression 
a. 
PHQ-9* 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
2. 
Intensity of Suicidal Ideation 
a. 
SSI 
 
X 
 
 
 
 
X 
 
 
 
 
X 
 
X 
3. 
Quality of Life 
a. 
SF-12 
b. 
QLI 
 
X 
X 
 
 
 
 
 
X 
X 
 
 
 
 
 
X 
X 
 
X 
X 
4. 
Insomnia Severity 
a. 
ISI 
 
X 
 
 
 
 
X 
 
 
 
 
X 
 
X 
5. 
Symptoms of PTSD 
a. 
PTSD-CL 
6. 
Symptoms of Anxiety 
a. 
GAD-7 
7. 
Level of Reward/Positive Affect from 
Experiences 
a. 
EROS 
8. 
Pain 
a. 
Brief Pain Inventory 
 
X 
 
X 
 
 
X 
 
X 
 
 
 
 
 
X 
 
X 
 
 
X 
 
X 
  
 
 
 
X 
 
X 
 
 
X 
 
X 
 
X 
 
X 
 
 
X 
 
X 
9. 
Patient Adherence** 
10. Treatment Receptivity 
a. 
Client Satisfaction Questionnaire 
X 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
 
X 
 
X 
X 

b. 
BA Acceptability Interview*** 
11. Therapeutic Alliance 
a. 
WAI 
 
 
 
 
 
X 
 
X 
12. Mental Health Treatment 
a. 
Medication and Treatment History 
Questionnaire* 
c. 
Medication and Treatment via CPRS* 
 
 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
 
13. Tobacco Use 
a. 
Tobacco Use Questionnaire 
 
X 
 
 
 
 
 
 
 
Note. P=in person assessment; T=telephone assessment 
*These measures are also given in the initial telephone screening assessment. 
**This is calculated after session 2, 3, and 4 of BA-PC 
***This measure will be administered at the last BA-PC session and sealed in an envelope to allow for confidentiality and for other research staff to stay 
blind to condition. 
 
Data Analysis and Statistical Considerations 
The data analytic strategy emanates from the primary aim and is in line with the method used to estimate the 
sample size necessary to adequately test the primary hypothesis. Initial analyses will be conducted using a 
series of 2 (Condition: TAU vs. BA-PC) vs. 2 (Time: baseline, week 12) repeated measures ANOVAs. The 
primary analysis will be conducted using the intent-to-treat approach; participants who are randomized will be 
analyzed according to their assigned group regardless of amount of treatment received.  The data will be 
screened for missing cases, outlier scores, and non-normal response distributions. Assumptions underlying 
statistical models will be assessed by examining standardized residuals, influence diagnostics and 
homogeneity of variance (e.g. among groups).  
Aim 1 (a, d): To evaluate the efficacy of a BA-PC in reducing depressive symptoms compared to TAU. 
MLM will be used to test the primary null hypothesis that no differences exist in the rate of change in 
depressive symptoms measured by the PHQ-9 between BA-PC and TAU against the two-sided alternative that 
differences do exist. A composite equation consisting of within and between person effects will be used to 
analyze our data. The within-person (level 1) equation estimates participants' unique intercept (time=0) and 
outcome trajectory. The between-person (level 2) equation estimates the average initial status (e.g., week 0 
PHQ-9 total score) and rate of change in the primary outcome (e.g., PHQ-9 total score). If the alternative 
hypothesis is confirmed, there would be a significant cross-level interaction between group and time of 
assessment suggesting a greater rate of improvement across time among participants randomized to BA-PC 
condition relative to TAU. 
Below is the multi-level composite equation that will be utilized to model depressive symptom severity. The true 
depression score for the ith person at the jth time point is a linear combination of a between-subject main effect 
for group, a main effect for time, and a cross-level interaction term between group and time allowing for the 
fixed effect slope estimate to vary between groups. Random effects include an intercept and slope. Both level-
1 and 2 (subject) residuals are assumed to be normally distributed. 
 
 
 
Our composite equation assumes a linear trajectory across time, based on our hypothesis of maintaining 
steady improvement in depression severity throughout the 12-week study period. This assumption may not be 
true given the timing and number of BA-PC sessions.  We propose two alternative theory-driven models to 
capture an immediate effect from BA and possibly an effect that may weaken during subsequent weeks. 
Exploratory graphical methods such as subject specific outcome trajectory plots and transformations will be 
used to assess the linearity (or lack thereof) across time. Non-constant trajectories such as a quadratic time 
effect and piecewise-linear (PWL) models will be explored to determine the most parsimonious model. Since a 
linear time model is nested within a quadratic, the likelihood ratio (difference in -2log-likelihood) test can be 
used to test model fit. In the case where a quadratic provides a better fit than a linear model, consideration will 
be given to the magnitude of the quadratic effect as well as parsimony. Since a constant rate of change model 
is not nested within the PWL model, log-likelihoods cannot be compared to assess model fit. However, the 
Akaike Information Criterion (AIC) statistic (-2LL + 2*# of parameters) can be used to assess fit among non-
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nested models. Below is a composite equation that includes two time segments (TS1, TS2) as well as cross-
level interactions between time segment and group.  
 
 
 
 
(d) The above models will be especially useful for assessing sustainability of long-term improvement up to 24 
weeks after randomization. An issue of analyzing long-term follow-up data is the rate of “missingness”. 
Methods described below pertaining to missing data will be inspected and, if plausible, used in conjunction with 
MLM to compare rates of improvement between the primary 12-week study period and long term follow-up. If 
the reliability of estimates during the long-term follow-up period are poor due to a high rate of missing data, 
simple means and confidence intervals will be calculated and used for descriptive purposes. 
While eligibility criteria require a stable history of depressive medication use or non-use, patients may change 
(drop, add) medications during the twelve week study period. While randomization should equalize patient 
characteristics between groups and other research has found it has no effect on the relationship between BA 
and changes in depressive symptoms74, 79, medication change during the course of the trial will be assessed 
and if necessary it can be examined as a time-varying variable. If a sufficient number of patients are on two or 
more medications during the course of this trial, we will assess the association (i.e. linear vs. nominal) between 
the number of medications and depressive symptoms using the likelihood ratio test. Then, the number of 
depressive medications (in stacked format) will be entered into our model primarily to adjust the other 
coefficients (time, time*group) for the potential confounding effect on the rate of change in depressive 
symptoms between groups, due to medication.   
Aim 1 (b): To evaluate the efficacy of a 4-session BA-PC in improving other secondary subjective 
outcomes compared to TAU. Similar to our primary depression outcome, secondary outcomes (i.e., sleep, 
quality of life, level of environmental reward from experiences) measured at baseline, week 6, and 12 will be 
analyzed by forming a MLM.  
Aim 1 (c): To evaluate a higher level of treatment engagement. For the number of treatment sessions 
completed, non-parametric methods, such as Kolmogorov-Smirnov, will be used to examine differences 
between BA-PC and TAU conditions.  For those participants continuing to experience moderate-severe 
symptoms at week 12, we will use chi-square techniques to examine rates of engagement in specialty care 
using data collected at 24 weeks. 
Aim 2: To evaluate Veteran receptivity and adherence to a 4-session BA-PC. Treatment receptivity will be 
measured using the CSQ, BA Acceptability Interview, and patient adherence. For the CSQ given at week 6 
and week 12, each of the eight items will be summarized by calculating the proportion of patients selecting a 3 
or 4 (excellent) within each randomized group. Also, the average summary score and 95% CI at week 6 and 12 
will be calculated within the TAU and BA-PC group. For the Likert-scaled items on the BA Acceptability 
Interview, the mean and 95% confidence interval will be calculated to help summarize participant’s receptivity 
to BA-PC in primary care. For qualitative questions on the BA Acceptability Interview, two raters will read each 
participant’s response and will summarize the responses114. Then, the two raters will discuss the summary 
responses they each identified and will reach a consensus that will inform the format and feasibility of BA-PC. 
As mentioned in the methods, a measure of patient adherence will be collected at each intervention session 
(i.e., proportion of the number of goals completed versus the number of goals identified as homework by the 
interventionist and patient at the end of each session) allowing for an overall patient adherence to be 
calculated and used as an indirect reflection of patient receptivity.  
Aim 3 (a): To evaluate the effectiveness of a 4-session BA-PC in reducing SI 
We plan to compare the presence and severity of SI between TAU to BA-PC using MLM for the purpose of 
generating robust effect size estimates. While p-values are inherently provided by statistical software 
packages, our emphasis is to calculate means and standard errors at each time point and within each group, 
thereby focusing on the magnitude of effects, not statistical significance. As alluded to in the Power Analysis 
section, this study is not necessarily powered for detecting differences in suicidal ideation among groups. 
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TS1
TS2
*
Group
TS1
*
Group
TS2
TS1
Group
2
1
21
11
20
10
01
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However, SI is relevant to depression and thus will be summarized for exploratory purposes using the most 
powerful statistical method (e.g. MLM, GEE) given the data characteristics. 
Note on Missing Data: One of the advantages of the proposed analytic method is the handling of incomplete 
outcome data without resorting to listwise deletion of participants. Our analytic method provides unbiased 
parameter estimates under a missing at random (MAR) assumption. Unfortunately, the validity of MAR cannot 
be determined from the data.  If the MAR assumption does not seem tenable, pattern-mixture models can be 
used to obtain valid parameter estimates by classifying participants into nominal categories according to the 
pattern of “missingness”115.  This nominal variable is then used as a predictor of the response. The associated 
regression coefficient and the parameter estimates of its interaction with other predictor variables quantify how 
the predictor-response association differs across the patterns of missing data.  For example, a model 
consisting of a main effect for time, a main effect for the nominal missing data pattern variable and an 
interaction term will inform us if baseline depression and depressive symptom trajectories differ according to 
the type of “missingness”. Overall population estimates can be calculated by averaging over the patterns of 
missing data115 and then statistically compared between groups116. A nice example of using a random-effects 
pattern-mixture model applied to a two group longitudinal study is shown in Hedeker and Gibbons110. 
Patient Safety 
Veterans with moderate-severe symptomatology who are eligible to participate in the study may inadvertently 
delay treatment to remain in the study during the treatment period (12 weeks). As a result, research staff will 
provide patients a thorough summary of the psychological and pharmacological options for services available 
to them at the end of the telephone screening session. Dr. Funderburk will assist in linking the Veteran to those 
services if the patient is interested. At any time during the initial 12-weeks of the study, if the patient indicates 
interest in seeking psychotherapy, the research staff will immediately help the Veteran with a referral and ask 
whether the Veteran would consider continuing the assessment portion of the study. In addition, the consent 
form thoroughly reviews this information.  
All Veterans will be instructed in the informed consent and initiation of BA-PC of the limits of confidentiality and 
the fact that if we feel they may be in imminent danger of harming themselves that we will involve other 
medical providers/emergency staff to protect their safety. All Veterans will be regularly assessed for SI 
throughout the study (at each telephone and in-person assessment using item #9 on the PHQ-9 and followed-
up with additional suicide risk assessment) and receive emergency contact information for Dr. Funderburk as 
well as the suicide hotline information at the initial session (see suicide protocol).  
Research staff will be intensively trained by Dr. Pigeon, a clinical psychologist, on assessing SI and 
determining risk level following protocols approved by the IRB. Drs. Pigeon, Funderburk, and Dollar will provide 
consultation and supervision throughout the study for any patient reporting SI. If the Veteran’s SI escalates to 
imminent risk, we will connect the Veteran with appropriate services and stop the study. 
As this study assumes an intent-to-treat design, at any time any patient can discontinue the intervention 
component of the study yet continue with the assessments. We would facilitate the referral to the appropriate 
care.  
Information on VINCI 
VINCI is a secure, central analytic platform and includes a cluster of servers designed to host databases 
integrated from national VA data sources, such as the Corporate Data Warehouse. This data includes the 
PHQ-2 screening data from the sites identified in this protocol. Once approved, the data will be placed within 
this secure environment of VINCI so only IRB approved staff can access the data. To ensure the protection of 
Veteran data, VINCI maintains compliance with the guidelines set forth by the VHA Handbook 1200.12 and all 
other applicable VA and VHA policies and regulations. All data will remain within the VINCI environment.  
 
Data Safety and Monitoring Plan 
Data Safety. To ensure safety of participants in the study proposed and validity and integrity of data 
collected, the co-PIs will oversee all data and safety monitoring functions. Both co-PIs will assume 
responsibility for these activities, but the research team will be advised that Dr. Pigeon will be the primary 
contact PI overseeing these activities. As described in the Multiple PI plan of this proposal, Drs. Funderburk 
and Pigeon will meet regularly to monitor study progress and discuss the implementation of monitoring 

procedures. Dr. Pigeon will meet regularly with the research coordinator and staff to review monitoring 
procedures and ensure all efforts are being taken to minimize risks to participants. 
To help monitor safety issues, we will have an independent Data Safety Monitoring Board (DSMB). As 
described below, we will track all negative outcomes and incidents as well as conduct interim data analysis 
every 12 months after the study has started. The study design will be significantly modified (and even 
screening stopped) on the advice of the DSMB that the study is creating potential harm to our participants.  
Both co-PIs will regularly oversee all aspects of the study, including participant recruitment, informed 
consent, data collection, management, and analysis, as well as regularly assess the risk/benefit ratio 
associated with participation in the study. As a result, all research staff will participate in an intensive training to 
help them understand the importance of reducing the risk for participants and learning how to recognize and 
report any adverse event or serious adverse event to Drs. Pigeon or Funderburk. Serious adverse events 
(SAE) may include: death, hospitalization due to worsening depressive symptoms or suicidal ideation, or all life 
threatening or disabling/incapacitating events among research participants. Adverse events may include (but is 
not limited to): physical injuries, worsened physical or mental health, or inadvertent disclosure of confidential 
research information. 
In the event of a SAE, the co-PIs will immediately communicate with the DSMB and Institutional Review 
Boards, followed by a written report in 24 hours. Jointly, we will make a decision whether there is sufficient 
evidence to necessitate suspension of data collection, further IRB review, modification of the protocol, or other 
changes to reduce potential risk to participants. Resumption of the study shall be based on the concurrence of 
the co-PIs, the chairperson of the IRBs, and the DSMB.  
In the event that an adverse event that is not an SAE is reported to the co-PIs, they will discuss the 
event with the DSMB. Immediate evaluation will occur to determine if any extra steps can be taken to minimize 
the likelihood of that type of adverse event occurring again. If changes can be made, a report/amendment will 
be written and submitted to the DSMB and Institutional Review Boards.  
As part of a standard practice at the Center for Integrated Healthcare, Dr. Pigeon will supervise the 
implementation of one audit within 4 months after study recruitment and one regularly per year afterwards of 
the materials collected and produced as part of the study at each site to ensure proper confidentiality and 
compliance with ethical principles, including informed consents, electronic medical record documentation, 
questionnaire data, and to make sure that the research staff are following established protocols.  
Dr. Pigeon, with support from Dr. Funderburk, will provide an annual summary report of all adverse 
events to the IRB and the DSMB as part of the annual review. If no adverse events have occurred, the report 
will state, “No adverse events affecting human participants have occurred during this project year.”    
Data Monitoring. To ensure adequate participant recruitment and enrollment, the co-PIs will weekly 
discuss the current numbers of participants contacted, screened, and enrolled from each site and compare 
those numbers to the expected based on our preliminary data. If after the first 4 months, it appears we are not 
reaching our expected N’s, the co-PIs will discuss potential barriers/obstacles and solutions with the DSMB, 
including the option of replacing or adding another site (e.g., Canandaigua VAMC due to its proximity to staff 
located at the Rochester clinic, current primary care support, and resources available to the project from the 
COE), if necessary. Discussions regarding recruitment and enrollment will continue at each meeting with the 
DSMB to ensure proper implementation of the study. 
Data Safety Monitoring Board. The purpose of the DSMB is to review protocols and consent documents 
for this study, monitor safety issues throughout the study, provide an overview of the quality of the 
accumulating data, and provide guidance on interim analyses and stopping rules. 
The DSMB will be comprised of 3 individuals with no direct involvement in the study or conflict of 
interest with the research team conducting the clinical trial. The DSMB will include individuals with expertise in: 
research and monitoring at-risk research participants; research in longitudinal clinical trials with Veterans; and 
research expertise with mental health and implementing collaborative care models. 
 
The DSMB responsibilities will include:  
 
i. 
Review and approve, disapprove, or suggest modifications to the study protocols and/or consent 
documents to assure both scientific integrity and study adherence to human subject protection policies. 
 
ii. Monitor, provide feedback, and report on scientific and ethical issues related to study implementation for 
the protection of human subjects and advise on ethical issues related to adverse events. The DSMB will 

monitor adverse event reports for purposes of determining whether their nature, frequency and severity 
are consistent with expectations.  
 
The DSMB, in coordination with the co-PIs, will report to the VA IRBs any unanticipated problems 
involving risks to subject.  
 
The DSMB can recommend remedies or other appropriate actions such as introducing new monitoring 
protocols, altering inclusion or exclusion criteria, or recommending changes in the informed consent 
documents.   
 
iii. Ensure that the study protocol maintains patients’ confidentiality in a manner that is appropriately 
balanced with issues of clinical care and safety. 
 
iv. Monitor data regarding effectiveness. The DSMB will review data for outcomes by treatment group. If 
differences in results between groups appear to be clinically significant, the DSMB will review whether 
the clinical trial should continue with or without further enrollment of new subjects. The DSMB has the 
authority to halt the trial as needed. 
 
v. Monitor data management activities. The DSMB may ask to review data relevant to quality control. The 
DSMB will review requests for interim analyses and approve, disapprove, require additional information, 
or defer decisions. 
 
 
At a minimum, the DSMB will convene on an annual basis throughout the study. During the first year, the 
DSMB will convene after the first 4 months of participant recruitment. DSMB meetings will be held in-person or 
via video teleconference. The Board Chair and co-PIs will decide upon the format of the meetings. Additional 
meetings or telephone conferences will be held on the recommendation of the DSMB. The Board Chair and the 
co-PIs will determine meeting logistics based upon clinical urgency and the availability of DSMB members. 
 
The co-PIs will submit reports to the DSMB one week prior to the scheduled meeting. These reports will 
include all reported data up and including 14 days prior to the reporting deadline (except for SAEs, which are to 
be reported within 24 hours of an event). For each meeting at which the study is to be considered or monitored, 
the co-PIs will present an overall progress statement. This brief statement will contain the assurance that the 
study investigators have considered the clinical trial’s progress and that there is/is not evidence of safety issues 
that should be addressed by the DSMB. 
Interim analyses will be conducted at each of these annual reviews to determine whether the emerging 
pattern of findings with respect to initial response or subsequent recurrence alters the risk-benefit ratio to the 
point that the study needs to be discontinued. Interim analyses will be planned in order to detect whether there 
are problems in recruitment, biases in attrition, other operational problems that affect the integrity of the study, 
and stronger treatment effects than anticipated that may lead to deliberation of prematurely discontinuing the 
trial.   
The DSMB will be kept apprised of all SAE’s and AE’s on an ongoing basis and will serve as the final 
arbiters of whether individual patients should be removed from the protocol. Although research staff, under the 
supervision of the co-PIs and co-I, are empowered to take whatever immediate action is necessary to safeguard 
the welfare of individual patients, the DSMB will be called upon whenever possible to render judgments in the 
advent of a serious adverse event. We acknowledge that there may be rare instances where some emergent 
situation occurs that was unanticipated regarding the welfare of the participant. In these situations, the VA IRB 
or the DSMB may be contacted to help resolve the situation. 
 
 
 
 
 
 
 
 
 
 

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