Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Phase: NA
Conditions: Depression
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
 
IIR03-315 Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in 
CBOCs 
Funding Agency: Office of Research and Development 
Principal Investigator: Jeffrey A. Cully, PhD 
January 26, 2018 
 
 

 
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Abstract 
Provide a summary of the study (recommended length: less than 500 words). 
Depression is a serious health condition that places tremendous burden on patients and 
healthcare systems and is especially prevalent among Veterans. The delivery of complex 
evidence-based psychotherapy depression care is challenging, especially in settings such as 
primary care and community-based clinics. Within the Veterans Health Administration (VHA), 
efforts are needed to assist community-based outpatient clinic (CBOC) clinicians to deliver 
evidence-based psychotherapy for depression. The proposed 4-year multi-site trial seeks to 
train and assist (facilitate) CBOC clinicians in the use of a brief cognitive behavioral therapy 
(bCBT) and to subsequently monitor the effectiveness of this treatment on Veteran outcomes 
using a direct-referral versus enhanced usual care patient randomized trial design. Aim 1 will 
develop a series of strategies to train and assist CBOC clinicians in the use of bCBT at 16 
CBOC sites connected to the Houston and Oklahoma City VA Medical Centers. Initial 
development of these strategies will involve CBOC clinician feedback in an iterative fashion that 
refines and enhances the training and support offered. Collectively, the development and 
assessment of these strategies will occur through a formal “formative evaluation” process.   
Formative evaluation will include a needs assessment as well as modifications to the clinical 
(bCBT) and implementation (clinician training and support) approaches. Following Aim 1, Aim 2 
will seek to determine whether depression outcomes for Veterans differ as a function of the 
intervention (direct referral to bCBT provided by CBOC clinicians vs. enhanced usual care) at 
post-treatment (4-month), and 8- and 12-month follow-up. A total of 232 Veterans with clinically 
elevated symptoms of depression will be recruited from CBOC clinics associated with the 
Houston and Oklahoma City VA medical centers (8 CBOCs per station). Eligible Veterans will 
be randomized to either 1) a direct referral to a CBOC bCBT trained VA provider or 2) an 
Enhanced Usual Care (EUC) arm where participants will receive depression information and a 
depression tool kit as well as a note placed in their electronic medical record. EUC participants 
will be asked to talk to their primary care provider about additional depression treatment options.  
No participants in either the bCBT or EUC groups will be restricted in any way from the receipt 
of VHA services. Rather, the study will use VHA databases and chart review procedures to 
document and control for health care use during the study period. 
Data from this project will help providers, managers, and policy makers to understand the 
potential impact, challenges, and benefits of using bCBT in VA CBOC settings. The implications 
of this study are multifaceted and will provide: 1) training and clinical support to existing CBOC 
clinicians who currently struggle to incorporate evidence-based psychotherapies into their 
clinical practice; 2) data on the impact of an implementation strategy (clinician support program) 
to aid CBOC clinicians in the use of a structured bCBT; and 3) clinical data on the effectiveness 
of bCBT for Veterans in CBOC settings as delivered by CBOC frontline clinicians. 
 
 

 
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List of abbreviations: 
bCBT – brief Cognitive Behavioral Therapy 
CBT - Cognitive behavioral therapy 
CBOC – Community-Based Outpatient Clinic 
Co I – Co-Investigator 
EBT – Evidence Based Treatment 
EUC – Enhanced Usual Care 
HSR&D – Health Services Research & Development 
HSR&D IIR 
IQuEST - Center for Innovations in Quality, Effectiveness and Safety 
LAC – Local Advisory Council 
NAC – National Advisory Council 
ORCA – Organizational Readiness to Change Assessment 
PARiHS - Promoting Action on Research Implementation in Health Services 
RE-AIM – Reach Effectiveness Adoption Implementation Maintenance 
VHA – Veterans Health Administration 
PHQ-9 (Patient Health Questionnaire) 
PFE - Progress-Focused Evaluation 
NIMH – National Institute of Mental Health 
PI – Principal Investigator 
RA – Research Assistant 
SC MIRECC – South Central Mental Illness Research, Education and Clinical Centers 
SF-12 – Short Form Health Survey Veteran Version 
 
 
 

 
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Contents 
Protocol Title: ............................................................................................................................. 5 
1.0 
Study Personnel .............................................................................................................. 5 
2.0 
Introduction ..................................................................................................................... 8 
3.0 
Objectives ......................................................................................................................10 
4.0 
Resources and Personnel ..............................................................................................11 
5.0 
Study Procedures ...........................................................................................................15 
5.1 Study Design ...................................................................................................................15 
5.2 Recruitment Methods.......................................................................................................23 
5.3 Informed Consent Procedures .........................................................................................26 
5.4 Inclusion/Exclusion Criteria ..............................................................................................26 
5.5 Study Evaluations ............................................................................................................28 
5.6 Data Analysis ..................................................................................................................35 
5.7 Withdrawal of Subjects ....................................................................................................39 
6.0 
Reporting ........................................................................................................................39 
7.0 
Privacy and Confidentiality .............................................................................................40 
8.0 
Communication Plan ......................................................................................................41 
9.0 
References .....................................................................................................................44 
 

 
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Protocol Title:  Effectiveness and Implementation of Brief Cognitive Behavioral Therapy 
in CBOCs 
1.0 
Study Personnel 
 
Principal Investigator/Study Chair:  
Jeffrey A. Cully, PhD 
Clinical Psychologist 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston 
713-794-8526 (office) 
Jeffrey.cully@va.gov 
 
Co-Investigators: 
 
 
Natalie Hundt, PhD 
MIRECC Post-Doctoral Fellow 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston 
713-440-4450 
Natalie.hundt@va.gov 
 
Michael Kauth, PhD 
Co-Director and Associate Director for Education, South Central MIRECC 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston  
713-440-4460 
Michael.Kauth@va.gov 
 
Mark Kunik, MD, MPH 
Director of South Central MIRECC 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston 
713-794-8639 
KUNIK.MARKE@va.gov 
 
Lindsey Martin, PhD. 
Health Science Specialist 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston  
713-440-4452 
Lindsey.Martin3@va.gov 
 
Nancy Petersen, PhD. 
Senior Biostatistician 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston  

 
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713-440-4443 
Petersen.nancyj@va.gov 
 
Shubhada Sansgiry, PhD. 
Programmer 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston  
713-440-4455 
Shubhada.Sansgiry@va.gov 
 
Kristen Sorocco, PhD. 
Clinical Psychologist 
Oklahoma City VAMC, 635 
405-456-1454 
Kristen.Sorocco@va.gov 
 
Melinda Stanley, PhD. 
Clinical Psychologist 
MEDVAMC, 580 
VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston  
713-794-8841 
Melinda.Stanley@va.gov 
 
 
Collaborators: 
Geoffrey Curran, PhD. 
Research Health Scientist 
Arkansas Department of Veterans Affairs 
501-255-1701 (office) 
Curran.geoffreym@va.gov 
 
 
Consultants 
 
 
JoAnn Kirchner, MD 
 
 
Director Mental Health QUERI 
Little Rock VAMC 
 
 
501-257-1719 
 
 
JoAnn.Kirchner@va.gov 
 
 
 
Lisa Kearney, PhD 
 
 
Senior Consultant Mental Health 
 
 
VA Central Office 
 
 
210-694-6222 
 
 
Lisa.Kearney3@va.gov 
 
 
 
 
 

 
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Andrew Pomerantz, MD 
 
 
National Mental Health Director, Integrated Services 
 
 
VA Central Office 
802-625-2040 
Andrew.Pmerantz@va.gov 
 
John Rader, MSW 
VISN 16 Mental Health Product Line Manager 
Little Rock VAMC 
501-228-8303 
John.Rader@va.gov 
 
Anna Teague, MD 
Associate Chief of Staff for CBOCs 
MEDVAMC, 580 
713-791-1414 ext. 28792 
Anna.B.Teague@va.gov 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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2.0 
Introduction 
 
Depression is a serious health condition that places tremendous burden on patients and 
healthcare systems and is especially prevalent in Veterans.1 In 2008, the VHA released the 
Uniform Mental Health Services Handbook (Handbook 1160.01) in an effort to expand services 
for Veterans with depression, including those in primary care and CBOC settings. 
Cognitive behavioral therapy (CBT) has strong empirical support and is effective for 
depression.2-4 Full-course CBT (12-16 sessions) is recognized as an evidence-based treatment 
(EBT) by VHA.5 However, the provision of full course CBT outside traditional mental health 
settings is complicated by a host of patient and system factors.6, 7 Briefer versions of CBT have 
been explored to increase access and efficiency of care while reducing barriers, especially in 
non-specialty mental health settings such as primary care.8, 9 Preliminary data suggest that 
bCBT (e.g., 4-6 sessions) is moderately effective. 10-12 
Although CBT improves patient outcomes, it is infrequently used in integrated healthcare 
settings.13,14 Within the VA, Cully et al.15 found that only 22% of urban and 15% of rural Veterans 
received at least 1 session of psychotherapy in the year following a depression diagnosis. 
Exposure was also limited, with 5.6% of urban and 2.4% of rural Veterans receiving 8 or more 
sessions.15 In 2008 the VA launched the Uniform Mental Health Services Handbook, which 
mandates that hospitals and larger CBOCs provide mental health services within the primary 
care setting and make available evidence-based psychotherapies for all Veterans with 
depression. These policies may be a step ahead of the current scientific literature, as studies 
are needed to document the real-world effectiveness of these treatments, especially for CBOCs, 
which face unique barriers to the delivery of mental health treatments. 
Clinical trials on bCBT are especially needed in care settings such as CBOCs where the 
provision of full course psychotherapy is under-utilized. CBOCs often have fewer mental health 
clinicians, limited access to mental health specialists and other referral networks, diverse patient 
needs, and logistical and patient attitudinal barriers.16,17 Data suggest that CBOCs are 
increasing access to mental health care but have limited follow-up services for depression.15,18,19 
A recent VA survey of 4,200 providers found that psychotherapies are often not available in 
CBOCs (see Appendix 1, VA memorandum). Further, CBOC clinicians feel significantly less 
knowledgeable and confident than urban providers in treating depression.20 Ultimately, research 
is needed to document the effectiveness and implementation potential of bCBT for VA CBOC 
settings. 
The proposed 4-year multi-site trial seeks to use an effectiveness-implementation design to 
examine a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression 
as delivered by existing mental health providers in VA CBOC clinics. Effectiveness-
implementation designs seek to simultaneously test: 1) strategies to improve care practices 
(e.g. clinician support programs) and 2) examine patient outcomes associated with the clinician 
program being implemented. For the current study, aim 1 will use a formal formative evaluation 

 
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process to better understand the contextual factors related to bCBT delivery including feasibility, 
adoption, and implementation (use in the clinical care setting). The study team will work with 
CBOC providers to train and assist them to more regularly use bCBT in their practice. Aim 2 will 
seek to determine whether depression outcomes differ as a function of the intervention (bCBT 
provided by CBOC clinicians vs. enhanced usual care) at post-treatment (4-month), and 8- and 
12-month follow-up. Veteran participants will be randomized to either a direct bCBT referral or to 
an enhanced usual care arm. 
The current investigation will examine whether existing VA CBOC mental health clinicians, with 
training and support, can effectively administer a structured bCBT intervention for Veterans with 
clinically elevated symptoms of depression. The project was designed to help providers, 
managers, and policy makers to understand the potential impact, challenges and benefits to 
using bCBT in VA CBOC settings. The implications of this study are multifaceted and will 
provide: 1) training and clinical support to existing CBOC clinicians who currently struggle to 
incorporate evidence-based psychotherapies into their clinical practice; 2) provide data on the 
impact of an implementation strategy (clinician support program) to aid CBOC clinicians in the 
use of a structured bCBT; and 3) clinical (patient) data on the effectiveness of bCBT for 
Veterans in CBOC settings. 
Clinician Participants 
All mental health clinicians at Houston and Oklahoma City CBOCs will be targeted for 
participation. CBOC clinicians whose scope of practice includes the delivery of psychotherapy 
will be invited to participate in this study. 
Veteran Participants 
The project will target all depressed Veterans treated at CBOCs in the Houston and Oklahoma 
City VAMC parent facility catchment area.  Inclusion criteria will include: clinically elevated 
symptoms of depression using the PHQ-9 (Patient Health Questionnaire) and the participant 
must have a primary care clinician at one of the above listed CBOCs. Exclusions will be limited 
to traditional criteria used in randomized psychotherapy trials. Exclusion criteria were kept to 
a minimum and only include factors that would make provision of a brief 
psychotherapeutic treatment inappropriate. Although psychotherapy may be appropriate for 
a wider patient population, brief psychotherapies (as proposed here) are believed to be of 
limited benefit to patients with more severe mental health difficulties. As such, exclusion criteria 
will include presence of cognitive impairment, bipolar, psychotic or substance-abuse disorders. 
Veterans currently receiving psychotherapy will also be excluded to avoid overlapping or 
competing services. Those receiving general mental health services including antidepressant 
medications will not be excluded. The study will not restrict the participant sample in any other 
manner. 
 

 
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3.0 
Objectives 
 
The proposed 4-year, multisite, randomized effectiveness-implementation trial will focus on the 
real-world application of bCBT for Veterans with depression, as applied by frontline CBOC 
practitioners. Effectiveness-implementation designs seek to simultaneously test: 1) strategies to 
improve care practices (e.g. clinician support programs) and 2) examine patient outcomes 
associated with the clinician program being implemented. The current project will invite mental 
health clinicians at the Houston and Oklahoma City CBOCs (16 sites) to participate. As part of 
study participation, providers will receive bCBT training and support from the study. Once 
trained, these CBOC clinicians will be asked to provide care to a Veteran patient population 
identified by the study team. Veteran participants from each respective CBOC, identified by 
study-based screening, will be randomized to a bCBT direct referral arm or to an Enhanced 
Usual Care (EUC) condition. Direct referral participants will be assigned to a CBOC provider 
trained by the study team in the use of bCBT. The study will pair providers and patients at each 
CBOC facility. EUC participants will not receive a direct referral. Rather, these participants will 
receive depression education materials, a note placed in their medical record indicating the 
presence of depression, and encouragement to seek services from their existing providers.  
Aim 1 – Implementation (training and assisted use of bCBT by frontline CBOC clinicians): The 
study will use a formal evaluation procedure to capture information on the clinical and 
implementation efforts as delivered by CBOC providers. Data will be used to modify the clinical 
training and support program. Known as a formative evaluation, the study will include a 
developmental assessment to collect data on clinician adoption, intervention fidelity, and 
individual interviews with stakeholders to obtain a deeper understanding of implementation 
challenges associated with using bCBT in the CBOC setting.   
Aim 2 – Clinical Effectiveness (patient outcomes): To determine whether depression (PHQ-9 
and Beck Depression Inventory) and quality- of-life (SF-12) differ as a function of bCBT referral 
(vs. EUC) at 4-, 8- and 12-month follow-ups. 
Exploratory Aims: A) To predict bCBT treatment response, using patient, treatment, and 
clinician variables. B) To explore patient and provider reactions to variable-length treatment 
options, using outcome data, patient and provider surveys, and qualitative interviews. C) To 
assess stakeholder (Veterans, clinicians, clinic managers/directors, as well as regional and 
national VA mental health leaders) perceptions of potential for wider implementation and 
maintenance of bCBT poststudy, using qualitative interviews and focus groups. 
 
 
 

 
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4.0 
Resources and Personnel 
 
The primary site for study coordination will be the Houston VAMC. Houston VAMC personnel 
will be responsible for obtaining database information and will conduct all recruitment of Veteran 
participants and local site (HOU) provider participants. Houston personnel will also be 
responsible for allocation (randomization) of Veteran participants to study arms and will 
coordinate care activities at the Houston CBOCs. Houston personnel will also conduct all 
baseline and follow-up evaluations with consented participants (by telephone). Houston 
personnel will also lead all clinician training efforts but will work collaboratively with Oklahoma 
City study personnel to implement the CBOC clinician training and facilitation efforts at the 
Oklahoma City CBOC locations. Oklahoma City study personnel will be responsible for 
recruitment of local site provider participants and Local Advisory Council (LAC) members.  
The PI (Cully) will assume overall responsibility for Veteran recruitment. Dr. Cully will work with 
Mr. Zeno and Mr. Robinson (see listing in personnel description below). Mr. Zeno and Mr. 
Robinson will be the primary study personnel responsible for sending out participant recruitment 
letters and conducting follow-up participant calls. They will also oversee a comprehensive 
training program for our “to be named” research personnel including additional research 
assistants and independent evaluators. Study personnel (Zeno, Robinson, and a “to be named” 
research assistant) will complete patient consent procedures and conduct baseline interviews 
with consented participants. Follow-up telephone survey (data collection) will be completed by 
independent evaluators (to be named) who will remain blind to participant randomization and 
other study procedures (e.g. clinical treatment information). 
All data and databases will be kept at the Houston VAMC behind the VA firewall. All study staff 
are VA employees and no data sharing agreements will be needed for this project. Transcription 
of audio recording will occur with a VA contractor and will occur via sharing of data behind the 
VA firewall. All data and database procedures will be overseen by Drs. Petersen and Sansgiry 
(see below). 
HOUSTON, TX – PERSONNEL: 
Jeffrey A. Cully, PhD (Principal Investigator). Dr. Cully will have overall responsibility for clinical 
and scientific aspects of the project. In this role, he will train and supervise research personnel, 
conduct project meetings, and be responsible for the scientific progress of the research 
including manuscripts and reporting of study results. He will also be responsible for the overall 
bCBT training program and lead the bCBT training team including Co-I’s Stanley, Hundt, and 
Sorocco. He will also work closely with Dr. Martin on all aspects related to the qualitative inquiry 
of the project. Dr. Cully is a past VA HSR&D Career Development and HSR&D Merit Review 
Awardee. He is a clinical psychologist (with a clinical appointment at the Michael E. DeBakey 
VA Medical Center) and health services researcher (with an appointment with the Houston 
HSR&D Center of Excellence). No salary is requested for his effort. 

 
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Melinda A. Stanley, PhD (Co-Investigator). Dr. Stanley is a clinical psychologist and NIMH-
funded researcher with specific expertise in the development and implementation of 
psychosocial interventions, including interventions for older adults in primary-care settings. Dr. 
Stanley is a core member of this research team which also includes close working relationships 
with Drs. Kunik and Kauth. Dr. Stanley has served as Co-I on the PI’s ongoing HSR&D IIR and 
previously served as a secondary mentor for Dr. Cully on his VA Career Development Award. 
As with the current IIR grant, Stanley will aid in the final development and implementation of the 
study intervention and training materials and will serve as a bCBT mentor and expert rater of 
CBOC clinician audio taped sessions. Dr. Stanley will also serve as a co-author and co-
investigator on manuscripts and future grant applications. 
Mark E. Kunik, MD, MPH (Co-Investigator). Dr. Kunik is a psychiatrist and health services 
researcher with specific experiences and expertise in researching issues related to psychiatric 
conditions in medically ill patient populations. He will primarily serve as a senior consultant and 
guide for participant recruitment, intervention implementation, manuscript development, and 
future grant planning. Dr. Kunik has served as a senior consultant on the PI’s ongoing IIR and 
previously as Dr. Cully’s primary mentor during his VA Career Development Award. In his role 
as co-investigator and mentor, Dr. Kunik will attend project meetings, as well as provide weekly 
one-on-one mentoring meetings to address the project and career development needs of the PI. 
Dr. Kunik is a VA staff psychiatrist and, therefore, no salary support is requested for his effort. 
Michael Kauth, PhD (Co-Investigator). Dr. Kauth is a clinical psychologist and staff psychologist 
with specific expertise in VA psychology training, VA implementation, and national VA mental 
health programming. Dr. Kauth is an active teacher, administrator, and researcher within the SC 
MIRECC and currently serves as a Co-I on Dr. Cully’s ongoing HSR&D IIR. He has a long 
history of collaborating and mentoring Dr. Cully in the areas of VA mental health planning and 
implementation theory and practice. For this project, Dr. Kauth, along with the other co-
investigators, will serve in an advisory capacity and will be actively involved in the study training 
and implementation procedures. Given his expertise he will be relied upon to guide the 
consultation and facilitation aspects of the training initiatives. Dr. Kauth will attend staff meetings 
and will serve as co-author and co-investigator on manuscripts and future grant applications. No 
salary support is requested for his effort. 
Natalie Hundt, PhD (Co-Investigator). Dr. Hundt is a clinical psychologist with an emerging 
research agenda to incorporate peer support programming to support psychotherapy practices 
for Veterans with PTSD and depression. Dr. Hundt is submitting a first version of her VA 
HSR&D Career Development Award (June 2013) where Dr. Stanley (project Co-I) and Dr. Cully 
(project PI) are serving as her primary and secondary mentors respectively. For the current 
project, Dr. Hundt will serve as Co-I and will work directly with Dr. Stanley as a clinician mentor 
and bCBT expert. Given Dr. Hundt’s clinical appointment at the MEDVAMC, no salary support is 
requested for her effort. 
Lindsey Martin, PhD (Co-Investigator) Dr. Martin is a medical ethnographer and qualitative 
methodologist. Dr. Martin will work closely with the PI and collaborator Curran to implement the 

 
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project’s comprehensive formative evaluation. Dr. Martin will lead the effort needed to conduct 
qualitative interviews and analyze/code the qualitative data. 
Nancy Petersen, PhD (Co-Investigator). Dr. Petersen is a biostatistician and senior 
methodologist at the Houston HSR&D CoE. Dr. Petersen has a longstanding relationship with 
the current study team and will serve as the senior statistical methodologist on the project. She 
has already served as a methodological consultant to the grant application and will continue to 
be actively involved in the planning of statistical analyses and will assist in writing manuscripts. 
She will actively work with the study programmer (Sansgiry) and oversee the development of 
programming for data entry and ensure the accuracy and consistency of data collection. Dr. 
Petersen's effort will decrease in year 2 due to reduced emphasis of statistical and 
programming issues and then increase during years 3 and 4 to allow adequate time for data 
procedures related to preliminary and final papers and reports. 
Shubhada Sansgiry, PhD (Co-Investigator). Dr. Sansgiry is a data analyst at the Houston 
HSR&D CoE. Dr. Sansgiry is currently serving as a data analyst on the PI’s ongoing HSR&D IIR 
and will continue to serve in that role for the current project. She will extract patient information 
from VA databases and assist the senior statistician (Petersen) in the construction and 
maintenance of the study database. 
Darrell Zeno, MS (Project Coordinator). Mr. Zeno will serve as the project coordinator and will 
assume day-to-day responsibility for project management, including study recruitment, 
coordination of all clinician referrals and independent evaluator sessions, and coordination of 
data collection, entry, and verification. Mr. Zeno has worked with the PI for over 7 years and 
brings a wealth of knowledge and expertise related to the management of large VA studies. He 
currently serves as the project coordinator on the PI’s ongoing HSR&D IIR. The use of a project 
coordinator at the GS 11/1 level will provide invaluable project support at a master's level in 
order to perform higher-order database construction and management tasks. The project 
coordinator will attend all project meetings and assist in preparing scientific reports. 
Andy Robinson, MS (Research Assistant). Mr. Robinson will conduct day-to-day recruitment of 
patients and assist with coordination of clinician referrals and independent evaluator session, 
and data collection / entry. Mr. Robinson will attend all project meetings. 
Research Assistant (RA) – Houston: To be named. The RA will also conduct day-to-day 
recruitment of patients and assist with coordination of clinician referrals and independent 
evaluator sessions and data collection/entry. The second RA will also attend all project 
meetings. 
Suzette Stine BS (Research Assurance Coordinator). The cost of a research compliance 
coordinator is shared by all investigators at the Houston HSR&D CoE (CoE). The coordinator 
directs, coordinates, and supervises the administrative functions of research compliance at the 
CoE. The coordinator audits and monitors all CoE research, and aids in the reporting of 

 
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compliance issues. The coordinator also provides education to investigators and staff regarding 
regulations, policies, and other VA and federal requirements related to research compliance. 
Alex Chau, BS (Study Data Management Specialist). Mr. Chau will perform dataset 
maintenance and upgrades. He will provide support and training for study personnel on project-
related software programs. He will ensure data privacy standards are maintained. He will 
process Data Use Agreements and PKI for study personnel. These functions are critical part of 
our data-management security plan to ensure compliance and the safety of all encrypted 
veteran data. 
OKLAHOMA CITY, OK – PERSONNEL: 
Kristen Sorocco, PhD (Co-Investigator). Dr. Sorocco is a clinical psychologist and researcher 
with the South Central MIRECC. Dr. Sorocco currently serves as the site PI on Dr. Cully's 
current multisite HSR&D clinical trial (IIR 09-088). For the current project, Dr. Sorocco will 
assume site PI responsibilities including regulatory oversight at the site level (IRB, Human 
Subjects, R&D Approvals, etc). She will also direct the RA at Oklahoma City which will include 
training and supervision. Dr. Sorocco has been and will continue to be an active member of this 
project team and will attend all full team meetings (by telephone) and use study data to publish 
first and secondary authorship manuscripts. Dr. Sorocco is a VA paid clinician and no salary 
support is requested. 
Research Assistant (RA) – Oklahoma City: To be named. This RA will be hired to facilitate “on 
the ground efforts” at the Oklahoma City site. This RA will be asked to support Dr. Kristen 
Sorroco (OKC bCBT expert) in regard to clinician training and consultation and other CBOC 
clinician facilitation efforts. The RA will also be asked to facilitate administrative duties related to 
data collection at the OKC site, including data from therapists and patients (where needed).  
LITTLE ROCK, AR – PERSONNEL: 
Geoffrey Curran, PhD (Collaborator). Dr. Curran is a medical sociologist and a qualitative and 
implementation science expert. Dr. Curran is also the Associate Director for the Mental Health 
QUERI. Dr. Curran will serve as a methodological consultant to the project. His role will focus on 
the development and refinement of the formative evaluation and implementation strategy of the 
project. No research activities will occur in Arkansas. 
CONSULTANTS: 
The consultants consist of regional and national leadership. The study team has formed a 
national advisory council with the consultants. We will meet with them annually to guide the 
project. The advisory council will provide feedback on project implementation and will serve as a 
critical link to aid in interpreting and disseminating study findings, thus ensuring the study is 
closely aligned with VA clinical and policy initiatives. 

 
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5.0 
Study Procedures 
 
5.1 Study Design 
 
The proposed 4-year, multisite trial seeks to use an effectiveness-implementation design21 to 
examine a bCBT intervention for Veterans with depression, delivered by existing mental 
healthcare providers in CBOC settings. Effectiveness-implementation designs seek to 
simultaneously test: 1) strategies to improve care practices (e.g. clinician support programs) and 
2) examine patient outcomes associated with the clinician program being implemented. Initial 
steps of this trial will refine a clinician training and facilitation process to increase the availability 
of frontline providers to deliver these evidence-based practices in CBOCs. The study will 
evaluate a series of provider and system-level strategies (STUDY AIM #1) designed to increase 
the use (adoption and fidelity) of bCBT by CBOC clinicians. Proposed strategies, developed 
from our prior work, will be modified using formative evaluation (FE) procedures with input from 
local and national stakeholders. Anticipated strategies include the use of standardized treatment 
materials, online clinician training, audit and feedback, and group and individual facilitation to 
reduce practice barriers and enhance successful delivery of bCBT.  
Clinical effectiveness will focus on the use of a bCBT intervention for depression adapted for 
use in the CBOC setting (STUDY AIM #2).9, 12, 21 The proposed bCBT intervention has been 
shown to be feasible and acceptable to patients and providers12, 22 and will be offered using in-
person and/or telephone sessions. Final treatment intensity (number of sessions) and duration 
(time in treatment) will be informed by real-time depression symptom response and ultimately 
decided by patients and clinicians but not to exceed 4 months.23 A total of 232 CBOC Veterans 
with clinically elevated symptoms of depression will be recruited from 16 Houston and 
Oklahoma City CBOCs.  Eligible Veterans will be randomized to a direct referral arm and 
offered a course of bCBT to be provided by existing VA CBOC providers or to Enhanced Usual 
Care (EUC; patient education) group where they will be provided with depression information, 
and the recommendation to seek additional depression care options through their primary care 
providers.  
All randomized participants will also receive a note added to their charts. The note will provide 
information about the patient’s level of depressive symptoms, the presence or absence of 
suicidal ideation reported, and any actions being taken by the research team. Notes will provide 
information about the assessment process, including information conveyed to the subject about 
the VA crisis hotline and encouragement provided to the patient to seek additional services 
through their existing care providers. The note will also indicate that the patient should continue 
to receive care as usual regardless of their study group assignment. Participants randomized to 
bCBT will receive a note, similar to the EUC group, with the exception being that the note will 
also indicate the patient was referred to a local CBOC provider for bCBT care. For subjects that 
enter the trial with depression but without suicidal ideation, the study team intends to provide a 

 
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detailed note for the chart but will NOT require an additional signature or co-signature from the 
PCP.   
The primary outcome, depression symptoms, will be evaluated at 4-, 8- and 12-month follow-
ups.  
Study Aim #1: Implementation (Training and Assistance Program) of bCBT by CBOC 
clinicians  
The bCBT intervention will be delivered by VA CBOC clinicians at the Houston and Oklahoma 
City affiliated CBOCs. All mental health clinicians at the 16 CBOC sites will be approached for 
inclusion in the study. We anticipate that a minimum of 12 clinicians will be enrolled, with a 
realistic estimate to approach 15 or more enrolled clinicians before the end of the trial, given 
staff turnover and program expansion efforts. Clinicians will receive online bCBT training with an 
emphasis on care for Veterans in the CBOC setting. Clinicians will be invited to participate by 
referral from clinic directors and/or VISN 16 mental health leadership. The study team will 
follow-up with the clinician and his/her supervisor to verify that study participation is appropriate. 
CBOC clinicians will receive advocacy (when needed) from the study staff and VISN leadership 
(see Appendix 2, letters of support) to resolve barriers to participation. Clinicians will not be 
restricted based on discipline or prior CBT experiences, but will be expected to have an interest 
in obtaining training and willingness to use bCBT in their practice. As seen in our ongoing trial, 
we anticipate that nurses, social workers, psychologists, counselors, and physician assistants 
will participate. The study team will try to work with clinicians to receive workload credit, but will 
not guarantee.  
All enrolled clinicians will receive a series of training and facilitation tools to assist their use of 
bCBT in their VA care settings. The proposed implementation strategy (training and facilitation 
tools) will be based on our prior work as outlined by Mignogna,et al. 2014.22 The proposed 
implementation strategy will initially include a series of techniques but will be modified with input 
from CBOC stakeholders during the development and refinement process. The initial strategy 
will include the following facets: 
bCBT Training and Certification: 24 Based on our prior work, bCBT training will be offered at 2 
levels –novice and experienced – to provide an individualized and efficient training experience. 
Tailored training is believed to be superior to a “1-size-fits-all” approach, which often is 
inefficient, reduces motivation, and increases frustration. Novice clinicians will have limited or no 
CBT experience, whereas experienced clinicians will have significant prior psychotherapy and 
CBT experiences. Clinicians’ experience will be collected through surveys, and the training team 
(Cully, Sorocco, Stanley, and Hundt) will determine a recommended training level. Clinicians will 
review the bCBT clinician manual and patient workbook prior to the introductory session. Novice 
therapists will be asked to complete an online training program modeled after our current 
work.22, 25 This 6 to 8- hour program is broken down into 30- to 45-minute modules. Each 
module contains didactic information, as well as audio vignettes to "model" intervention 
procedures. Following completion of the online training, novice therapists will be “certified” for 

 
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bCBT patient care. Initial "certification" will be viewed as an intermediate implementation 
outcome. However, the study team will provide additional training opportunities (e.g., audit and 
feedback, facilitation, clinic support) to aid bCBT use over time. 
bCBT Mentoring and Facilitation:24, 26 Each CBOC provider will be paired with a "mentor." 
Mentors, members of the study team, will serve as bCBT experts, as well as practice facilitators 
to enhance adoption. Clinicians will be introduced to mentors at study enrollment, and monthly 
meetings will be scheduled for the first 6 months (every 3-4 months thereafter) to discuss 
successes and challenges associated with using bCBT. Facilitation will be a "mediating 
intervention" that enables and supports the larger bCBT intervention.27 
Facilitation will use a variety of techniques to help therapists put their bCBT knowledge into 
practice (QUERI facilitation guide).28 The study team will also coordinate monthly group calls 
with clinicians to share experiences across settings and to provide clinicians the chance to 
interact with one another (e.g., practice community). Group calls will address how to apply 
bCBT in a complex patient population (e.g., advanced bCBT training) and within a competing-
demands CBOC environment (e.g., managing a psychotherapy practice). 
Intervention Fidelity and bCBT Feedback: Ratings of adherence and competence will be 
assessed, using a previously developed measure.8, 29 BCBT ratings will be assigned, using 
audio taped sessions and the standardized rating measure, with scores ranging from 0-8, where 
6 is considered "good." 8, 29 It is anticipated that some participants may decline to be recorded. 
In these instances participants will be included in the larger study but will not be audio recorded. 
Audio recordings will be uploaded to a VA shared drive and will not leave the VA server). All 
sessions for each clinician’s first bCBT patient will be reviewed by a bCBT expert. Feedback will 
be provided by mentors (Stanley and Hundt) to the clinician after sessions 2 and 6 (or at the end 
of treatment). Following the initial patient, bCBT experts will review 2 randomly selected 
recordings and will provide feedback to clinicians every 3-4 months. Ongoing monitoring of 
therapists will identify "developmental areas," defined as scores of 5 or less on any skill. 
Therapists, regardless of ratings, will not be removed from the trial but will receive feedback to 
address needs. This training model closely resembles training initiatives within the VA. 
Measurement and analyses of fidelity ratings will also provide data for the project’s 
implementation and progress-focused formative evaluation. 
Study Aim #2: Clinical Effectiveness / Patient-Participant Randomized Arms 
ARM #1: Referral to Brief CBT (bCBT) 
Participants randomized to the bCBT referral intervention9, 12, 30 will be assigned directly to a 
study trained CBOC provider who will deliver bCBT as part of their established clinic 
procedures. The bCBT will use a flexible, patient-centered approach to increase engagement 
and adherence while addressing the mental and physical health needs of depressed Veterans. 
Emphasis was placed on maximizing intervention potency and minimizing intensity and duration 

 
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to improve implementation value. A bCBT therapist manual and patient workbook provide 
structure and increase patient participation. The patient workbook includes intervention session 
information and worksheets, along with homework assignments to facilitate between-session 
patient activities. Importantly, the patient workbook provides the structure needed to conduct 
telephone sessions. 
The proposed bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 
minutes, and the option to include 3 more sessions if the participant and clinician deem 
necessary (see Table 1). All participants receive an initial (core) session when participants work 
with their study clinician to set goals that are not restricted to "emotional health" (e.g., 
depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a 
chronic condition). This flexible, patient-centered approach allows clinicians and patients to 
target broader factors that may impact mood and depression. Following the core session, 
clinicians provide participants with a series of module choices, from which they select skills that 
match their most pressing needs. Skill modules use psychosocial techniques established in our 
prior trials8, 9, 12, 30, 31 and flexibly apply these skills to improve mental and physical health. Each 
module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced 
and customized to the patient's immediate goals, regardless of the focus (physical or mental 
health). 
Table 1. bCBT Intervention Overview 
 
 
Participants randomized to the bCBT direct referral arm will have information obtained from the 
assessment (e.g. responses from the PHQ-9, level of physical pain experiencing, any comorbid 
psychiatric diagnoses, and their contact information forwarded to a study-consented CBOC 
provider (via encrypted email), who will schedule the patient for an initial treatment session. The 
assessment information is provided to inform the clinician on areas of difficulty the patient may 
be experiencing to aid in recommendation of treatment modules. Participants and clinicians will 
work collaboratively to determine the modality of treatment – telephone, face-to-face, or a 
mixture. All bCBT sessions are deliverable by telephone but clinicians and patients may opt to 
have face-to-face meetings. Data on telephone and face-to-face meetings will be collected and 
examined in treatment analyses. Clinicians will be encouraged to offer 6 weekly treatment 
sessions but may alter the intensity or "dose" of treatment, based on Veteran depression 
response scores and/or provider/patient decision to discontinue treatment. For completers, the 
final treatment "dose" may include between 3 and 9 sessions over a course of up to 4 months. 
Clinicians will be asked to complete the PHQ-9 during treatment sessions to assess treatment 

 
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response. Regular PHQ-9 administration is consistent with bCBT and measurement-based 
care. Data on treatment sessions will be documented using template CPRS clinician notes to 
facilitate clinician documentation, allowing the study team to monitor and extract important 
treatment information during and after the trial. 
Variable Length of Treatment (see Figure 1): Clinicians will provide bCBT with a flexible 
treatment intensity and duration, based on an innovative model described by Galovski et al.23 In 
the current study each Veteran's depressive symptoms will be assessed, using an a priori PHQ-
9 outcome benchmark of 50% reduction in baseline symptoms33-35 to determine treatment 
response and to provide guidance to clinicians and patients about the potential for treatment 
discontinuation. Clinicians are encouraged to talk about discontinuation prior to treatment 
completion to 1) ensure that patients continue to see value in the treatment and wish to continue 
the treatment 2) explore additional or alternative treatment options that may be more in line with 
patient needs and/or expectations. Ideally, patients will continue with the bCBT intervention but 
some may elect to explore other treatment options.   
PHQ-9 data will inform treatment progress but will not dictate treatment discontinuation. Rather, 
clinicians and patients will decide on the final length of treatment (up to the maximum 9 
sessions in 4 months). A response of 50% reduction in depressive symptoms was chosen, 
based on prior work and evidence from other studies.33-35 This response criterion also 
appropriately classifies responders with variable depression levels. A decrease in symptoms by 
50% for an initial PHQ-9 of 10 (the lowest possible entry score) would require a 5-point change 
(the minimally clinically important difference for the PHQ-9).36  
During active treatment, clinicians will be asked to discuss depressive symptoms and response 
with participants as part of the treatment process. Providers will be encouraged to deliver bCBT 
as long as it remains appropriate for any given patient. If a patient is discovered to have 
additional needs that make the use of bCBT inappropriate, the clinician can opt to seek 
additional or alternative care for the patient. The presence of severe depression, substance 
abuse, and comorbid PTSD or anxiety disorders could all require the clinician to change or add 
treatments. At the end of the 4 month treatment period, clinicians will be encouraged but not 
required to discontinue treatment. For patients who reach the response criterion, clinicians will 
introduce the potential for treatment discontinuation. For patients who do not reach the targeted 
depression goal by the final session (6th session), clinicians will work with the patient to 
determine whether additional sessions would be helpful. The provider will have the option to 
continue care or refer the patient to other therapies that are not a part of the research study 
based on their clinical judgment.  
“Rapid” responders will be asked to stay in treatment for a minimum of 3 sessions. For 
nonresponders, treatment may be extended up to a maximum of 9 sessions.  
 
Figure 1. Response to bCBT Treatment and Determination of Treatment Ending 

 
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ARM #2: Enhanced Usual Care 
Following randomization, EUC participants will receive feedback and educational materials 
about managing depression37 and a letter encouraging them to discuss treatment options with 
their VA primary care provider (see Appendix 9, Patient Educational Brochure and Appendix 11, 
Usual Care Letter). The EUC arm represents a modest enhancement to the ongoing CBOC 
practices in that it will add routine, comprehensive screenings for all consenting patients, 
identification of depressive symptoms, encouragement to address depression using print-based 
materials, and notification of the patient's primary care provider. EUC participants will be given 
the same reimbursement as bCBT participants and will be asked to complete the same 
assessments at 4-, 8-, and 12-month follow-ups. Following each assessment, findings will be 
documented within each patient's electronic medical record. Because depression identification 
and treatment are a priority within VA, we fully expect that enrolled participants may receive 
depression treatment (e.g., antidepressants or depression care management). Although 
medications are a first line of care for depression, data suggest that antidepressant medication 
use remains modest.38 
NOTE: Participants in EUC will NOT be restricted from any mental health services. To address 
the possible confounding effects of co-occurring mental health treatments, we will measure 
health services utilized, with particular emphasis on use of psychotropic medications, 
psychotherapy, and other specialty mental health care. 
Minimization of Risk 
Provider Participants: Prior to any provider recruitment efforts, union representatives at the 
Houston and Oklahoma City VAMCs will be notified of the study proposal. Potential therapists 
will be referred by their clinic director and/or VISN mental health leadership and subsequently 
screened for appropriateness by the study investigators. The study team will be careful to 
ensure that VISN leadership or clinic directors do not require clinicians to engage in this work.  
Any clinician who does not wish to participate will be excluded. Clinician participants final 
decision to participate or not will not be made known to their supervisor or VISN leadership.  
Clinicians who wish to participate (receive the training and provide care) will be enrolled. 
Therapist information related to performance and feedback will be coded within the study so that 
no therapist specific information will be identifiable outside of the study itself. 

 
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Veteran Participants: To maximize confidentiality, participants will receive a unique study 
number that is attached to study related data. Data will be kept in locked file cabinet housed in a 
data storage room that has a security keypad as entry. All electronic data files will be 
maintained within the VA setting and behind the VA firewall. In addition, all electronic data files 
will be password protected for additional security. 
Local Advisory Council Participants: Prior to any provider recruitment efforts, union 
representatives at the Houston and Oklahoma City VAMCs will be notified of the study proposal. 
Potential LAC members will be referred by their clinic director and/or VISN mental health 
leadership and subsequently screened for appropriateness by the study investigators. The study 
team will be careful to ensure that VISN leadership or clinic directors do not require employees 
to participate in the LAC. Any employee who does not wish to participate will be excluded.   
No participants will be identified in any reports that may be published. Intervention participants 
are not required to take any study medication or undergo any invasive procedures; therefore, 
we do not foresee any study related adverse events. 
In the event of a participant who reports suicidal ideation during the assessment or treatment 
process, a specific protocol will be used to triage the participant to the appropriate source of VA 
care. As part of all baseline and follow-up assessments, study staff will closely monitor and 
explore all indications of suicidal thinking. The PHQ-9 item #9 asks for responses about 
thoughts of being “better off dead or hurting yourself in some way”. Study staff will follow up on 
any positive response to this item using a structured crisis assessment protocol. The structured 
assessment will distinguish between passive vs. active suicidal thinking, identify any intent or 
plans for self-harm, and inquire into family, health care, or community supports (see Appendix 3 
for detailed listing of the structured assessment). Participants who express suicidal ideation will 
be immediately forwarded to a study investigator who will triage and refer for care as 
appropriate. If it is an emergent situation the research assistant will page an on-call licensed 
practitioner (study PI or co-investigator). The PI, and other study staff (Drs. Kunik, Kauth, 
Stanley, and Sorocco) are all licensed mental health practitioners and will serve as the on-call 
staff. 
We will also monitor changes in depression symptoms over time and initiate contact with 
participants who report an increase of 5 points or more on the PHQ-9 from baseline or between 
any two study assessments. Reports will be run by the study team on a weekly basis to identify 
participants with increased depressive symptoms. 
 
 
 
 

 
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Potential Benefits 
Provider Participants: All clinicians will receive expert bCBT training and ongoing consultation to 
learn how to apply bCBT in their daily practice. The risk-benefit ratio of the study suggests that 
the proposal is reasonable given the potential direct benefits to participants and providers via 
the intervention and education provided. 
Veteran Participants: Participants randomized to the direct referral arm will be provided with 
bCBT treatment while participants randomized to the enhanced usual care arm will receive 
educational products designed to increase their ability to manage their emotional health issues. 
Additionally, EUC participants will be encouraged to seek services for their depressive 
symptoms. Participants may feel less depression, worry, and associated symptoms and may 
experience an improved ability to perform normal activities of daily life.  
Local Advisory Council Participants: LAC members are expected to experience few direct 
benefits as a result of participating in the developmental evaluation. The benefits are largely 
scientific in nature and will facilitate the integration of the research program into existing 
workplace procedures. Having an opportunity to provide feedback on this process may be a 
rewarding experience for some participants, and the information gathered may improve the 
quality of care of future patients.  
The risk-benefit ratio of the study suggests that the proposal is reasonable given the potential 
direct benefits to participants via the intervention and education provided as well as the potential 
for this research to benefit other Veterans and the larger research and clinical community by 
providing detailed information on the use of brief cognitive-behavioral therapy for Veterans in 
rural health care settings. 
The potential benefits of the study are numerous, with many involving the provision of care to 
participants but also including information related to how the VA can improve its ability to train 
and implement psychotherapies in the primary care setting. Data to be obtained from this study 
will provide important information on the use of brief cognitive-behavioral therapy for Veterans 
with depression as provided by frontline VA practitioners. Should the intervention prove 
effective, the study team will target clinical and research initiatives designed to further increase 
the implementation of these procedures within VA. Risks of the study are minimal and many 
research participants will be provided with care that may not be available within existing care 
settings. 
Description of study population 
Clinician Participants: The bCBT intervention will be delivered by VA CBOC clinicians at the 
Houston and Oklahoma City affiliated CBOCs. All mental health clinicians at the 16 CBOC sites 
will be approached for inclusion in the study. Clinicians will not be restricted based on discipline 
or prior CBT experiences, but will be expected to have an interest in obtaining training and 
willingness to use bCBT in their practice. As seen in our ongoing trial, we anticipate that nurses, 

 
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social workers, psychologists, counselors, and physician assistants will participate. Clinicians 
may receive workload credits for bCBT delivery since these practices will be delivered as part of 
their clinic duties. The study team will work with the clinician to receive workload credit, but will not 
guarantee that workload credit can be obtained.   
Veteran Participants: Recruitment efforts will utilize VA databases, opt- out recruitment letters, 
and follow-up phone calls. Participants randomized to the intervention arm will receive treatment 
from one of the 16 CBOC sites within the Houston and Oklahoma City regions and who screen 
positive for depression on the PHQ-8. A total of 232 Veteran participants will be randomized. 
Local Advisory Council Participants: 
The LAC will consist of VA employees working at CBOC facilities. CBOC clinicians already 
consented as study clinicians, administrative staff, and facility leadership at the 16 CBOCs are 
eligible for participation. No contract CBOCs or contract employees will be approached.  
Added protections for vulnerable populations 
No vulnerable populations will be targeted for enrollment, except for VA employees who 
provide mental health treatment to Veterans. No added protections are planned outside 
those described above. 
5.2 Recruitment Methods 
 
Clinician Participants 
Clinicians will be VA employees working as mental health clinicians at CBOC facilities. All VA 
mental health clinicians at the 16 CBOC sites will be approached for inclusion in the study. No 
contract CBOCs or contract mental health providers will be approached. We anticipate that a 
minimum of 12 clinicians will be enrolled, with a realistic estimate, given staff turnover and 
program expansion efforts, to approach 15 or more enrolled clinicians before the end of the trial. 
Clinicians will be invited to participate by referral from clinic directors and/or VISN 16 mental 
health leadership (see Appendix 4, Clinician Recruitment Letter). The study team will follow-up 
with the clinician and his/her supervisor to verify that study participation is appropriate. Study 
staff will follow up with the clinician via email to confirm interest.  If there is no response to the 
email a follow up phone call will be placed.  CBOC clinicians will receive advocacy (when 
needed) from the study staff and VISN leadership (see letters of support) to resolve barriers to 
participation. Clinicians will not be restricted based on discipline or prior CBT experiences but 
will be expected to have an interest in obtaining training and willingness to use bCBT in their 
practice.  
 
 

 
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Veteran Participants 
Based upon sample-size calculations (including attrition over time), the total sample to be 
randomized is 232. Participants are not randomized until after conformation of depression after 
the baseline. Because final determination of study inclusion cannot be determined until the 
baseline appointment, we anticipate needing to provide consent to approximately 300 Veterans 
total. Approaching Veterans who are not necessarily treatment seeking is a critical component 
of the project and allows for increased reach to Veterans who might otherwise go unrecognized 
by the healthcare system. The recruitment procedures comprise four stages designed to 
maximize reach while minimizing participant burden and confusion about study procedures. 
Local Advisory Council Participants 
The LAC will consist of VA employees working at CBOC facilities. CBOC clinicians already 
consented as study clinicians, administrative staff, and facility leadership at the 16 CBOC are 
eligible for participation. No contract CBOCs or contract employees will be approached. We 
anticipate recruiting 4 clinicians, 2 administrative personnel, and 2 Parent Facility leaders for the 
LAC. Employees will be invited to participate by referral from clinic directors and/or VISN 16 
mental health leadership. Study staff will follow up with the clinician via email to confirm interest 
(see Appendix 4C, LAC Recruitment Letter). If there is no response to the email a follow up 
phone call will be placed.   
Figure 2. Veteran Recruitment Flow Chart 
 
 
 
 
Stage I: 
The first stage will consist of a data extraction from national VA databases to identify the pool of 
potential study participants. This data extraction will target patients who received care at the 
Houston and Oklahoma City CBOCs. CBOC/Facility categorization will be based on the location 
of the patient’s current primary care provider. Initial database extraction will only be used to 
identify Veterans who receive care at one of the 16 CBOCs in the HOU and OKC regions. The 
study will not target any specific patient populations – rather the study will request information 
on all Veterans treated at each of the respective CBOCs. 
The following participant recruitment strategies were designed to ensure that enlisted 
participants would be clinically appropriate for treatment of depression using bCBT in 
the CBOC setting.   
Stage I:  
Data Extraction 
Stage II:  
Recruitment letter 
Opt-Out Cards  
Initial Phone Contact 
Chart Reviews 
Screening 
Stage III:  
Informed Consent 
Baseline Assessment 
Stage IV:  
Randomization 

 
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Stage II: 
In stage two, study personnel at the Houston VAMC will mail potential participants an opt-out 
letter, and an opt-out card (self-addressed and stamped) to their home address as listed in 
CPRS. The letter will state that study staff will call within two weeks unless the patient requests 
not to be contacted. The patient may make a no-contact request via a telephone number listed 
in the letter or by mailing back the enclosed opt-out card. During the initial phone contact, a 
research assistant will administer the screening questions. The RA will follow a script for the 
telephone contact that includes assent procedures for the screening questions (see Appendix 5 
for screening telephone script and Appendix 6 for screening assessments). Participants will be 
asked questions to screen for depression (PHQ-8), cognitive functioning (6 –item Cognitive 
Screen), presence of bipolar and psychotic disorders, substance use (MINI), and alcohol use 
(AUDIT-C). Eligible participants (those who screen positive for depression on the PHQ-8 and 
are not excluded for more severe mental health issues) will progress to the final recruitment 
procedures. After screening eligible, a chart review will be conducted to confirm the participant 
is not currently receiving any other psychotherapy treatment. Current treatment will be defined 
as patients that have received a psychotherapy appointment within the last 3 months. Chart 
reviews will be conducted by staff in Houston and Oklahoma City.  Staff in Houston will utilize 
the Compensation and Pension Record Interchange (CAPRI) to review the charts of Oklahoma 
City participants. 
Stage III:  
A full baseline assessment will be scheduled within 1-2 weeks of the telephone screening. The 
independent evaluator assigned to complete the baseline assessment will complete the informed 
consent process with the participant before beginning the assessment.  
Stage IV: 
Participants still eligible based upon a second positive response to the PHQ-9 will be 
randomized to the direct referral or EUC groups.   
Participants identified to be at the upper limits of depressive symptoms will not be 
restricted from participation. We plan to offer the treatment to severely depressed 
patients, knowing they may require additional services beyond the study, either as an 
augmentation of or alternative to the bCBT.   
Only Veteran participants will be compensated in the study. Study clinicians are not eligible for 
compensation given their VA appointment. Veteran participants can receive a total of $110 if 
they complete all study assessments ($20 baseline, $30 for 4-, 8-, and 12-month assessments).  
Payment will be in the form of a debit card that will be mailed to their address. If a participant 
has electronic funds transfer set up with the VA then they will be eligible to have the money 
deposited directly into their account. The debit card process can take up to 8 weeks to be 
received and an electronic fund transfer takes approximately 10 days to appear in the account.  

 
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A subset of Veterans randomized to the direct referral arm will be asked to complete a one-time 
qualitative interview regarding their previous experience with emotional health services and 
experiences in the brief CBT program. We will approach equal numbers of Veterans who have 
completed a) 4 or more sessions, b) 1 – 3 sessions, or c) no sessions, for a total of 9-12 
Veterans.  The interview will last 30-45 minutes, and Veterans will be compensated $30 for their 
time completing the interview.  
5.3 Informed Consent Procedures 
 
The consent process will occur before administration of the baseline assessment for Veterans 
and before training for clinicians.  LAC members will be consented during the first month of the 
active phase of the project. The informed consent process will be completed by the local Site 
RA or the Project Coordinator. This study does not involve subjects with impaired decision-
making ability or who have legally authorized representatives. 
Clinician Participants 
Clinicians will be recruited from all 16 CBOCs and included as study participants. Local union 
representatives will be informed of the study. Currently, there are 24 mental health clinicians 
who provide care to the 16 identified CBOCs.   
The study is requesting a waiver of documentation of informed consent for clinician participants.  
Potential therapists will be referred by their clinic director and/or VISN mental health leadership 
and subsequently screened for appropriateness by the study investigators.   Clinicians identified 
as interested will be contacted via email by study staff to confirm interest. A follow up call will be 
made if there is no email response from the clinician. When interest is confirmed, a time will be 
set up to review the informational document (see Appendix 4E) with the clinician by phone. The 
informational document will be emailed to clinicians prior to the meeting. During the meeting, the 
study team member will review the document and explain all procedures requested of a 
participating clinician and address any questions posed.  In some instances, the consent 
process will take place during the initial phone call confirming interest if the clinician is available 
at that time.  If so, a copy of the informational document will be emailed at that time.  Once a 
clinician gives their consent, their name will be added to the master list of enrolled participants. 
Veteran Participants 
The study is requesting a waiver of documentation of informed consent, as well as a waiver of 
HIPAA authorization for veteran participants. The study requests a waiver of informed consent 
and HIPPA authorization for recruitment stages 1 and 2 which occur prior to the formal consent 
process (Stage 3). All participants will be mailed a study introductory letter informing of the 
opportunity to participate (see Appendix 5F Recruitment Letter). An opt-out card will also be 
included with the recruitment letter (see Appendix 5B, Opt-out card). Participants will be able to 
opt-out either by using the provided telephone number or by mailing back the opt-out card. Any 
one that does not opt-out within two weeks from the date of the mailing will be called and 
provided with an explanation of the study. A telephone script will include assent procedures (see 

 
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Appendix 5C, Script for Screening Phone Contact). This initial phone contact will begin with 
reference to the recruitment letter and will explain the purpose of the research and inquire about 
participants’ interest. Potential participants will also be provided with a number they can use to 
verify that the project is VA research. After assent, interested participants will be asked a series 
of survey-based screening questions that will take approximately 10-15 minutes. Eligible 
participants (those who screen positive for depression on the PHQ-8 and are not excluded for 
more severe mental health issues) will be scheduled for a baseline assessment to occur 2 
weeks after the telephone screening.  
Participants’ informed consent will be obtained at the baseline appointment. Prior to the initiation 
of the baseline, a telephone script (see Appendix 5D) will be utilized by the RA. As part of the 
script the RA will review the Detailed Patient Information sheet (see Appendix 5E). The 
information sheet will describe the procedures involved in the project as well as their rights as a 
participant in a research study. Participants will also be informed a select sample of 
assessments (5%) will be audio recorded for data integrity checks and training purposes of 
Independent Evaluators (IE). Before initiating the assessment, selected participants will be 
asked to be recorded. In addition, eligible participants randomized to the bCBT direct referral 
group, will be asked to have their session audio recorded by their clinician. Audio consent will 
be explained as an optional matter and not a requirement for participation. Potential participants 
will be provided an opportunity to ask questions. After questions have been answered to their 
satisfaction, they will be asked if they give their verbal consent to proceed with the assessment 
questions. Once the RA obtains verbal consent from the participant their name will be added to 
a master list (see Appendices 5B5E for a complete listing of patient recruitment materials).  
Participants that decline being audio recorded will have a note placed in the research master 
record indicating as such. Providers will be notified via encrypted email of participants 
randomized to the direct referral group that declined being audio recorded.  
Qualitative Interview 
Participants randomized to the treatment group will be asked to complete a one-time qualitative 
interview.  The study will target participants that fall into 3 categories: a) completed 4 or more 
sessions; b) completed 1 – 3 sessions; and c) completed 0 sessions.  A total of 12 participants 
(4 from each category) will be approached to complete the interview.  Participants will be 
contacted at the 4 month time period or immediately following their decision to end treatment.   
Veterans will be contacted to determine their interest in completing the qualitative interview.  
Veterans that agree to complete the interview will be scheduled for a phone meeting and a copy 
of the qualitative interview informational document (see Appendix 5H) will be mailed to them at 
that time.  The informational document will explain the procedures for the interview and the 
participant’s rights as a research participant and will be reviewed during the telephone meeting. 
The participant will have an opportunity to ask any questions.  After the questions have been 
answered to the participant’s satisfaction, their verbal consent will be obtained to proceed with 
the interview.   

 
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The waivers of documentation of informed consent and HIPAA are requested because the 
intervention has a specific focus on increasing rural Veterans’ access to mental health services 
via strategies such as telephone-based assessments and treatment alternatives. Determining 
the effectiveness of these strategies requires a sample of Veterans that represents the Veteran 
community at-large and does not include only highly selected, motivated, or resourceful 
individuals. The proposed recruitment strategies represent the study team’s attempt to reduce 
the research burden on our Veteran participants and to reach a wider audience of Veterans, 
many of whom do not get the care they need. The requirement for written HIPAA authorization 
would increase the research burden on these Veterans and preclude their participation. 
Local Advisory Council Participants 
LAC participants will be recruited from all 16 CBOCs and included as study participants. Local 
union representatives will be informed of the study and all enrolled employees will sign written 
informed consent (see Appendix 4D).  
All project staff is required to undergo significant training on the protection of human subjects, 
research methods, and the importance of integrity in the research process. Study team 
members who are authorized to recruit participants and/or obtain informed consent will be 
trained on specific study consent procedures by the study PI (Cully), the Project Coordinator 
(Zeno), or the main site RA (Robinson). Each person will be required to administer a mock 
consent where they will receive hands on experience on possible questions and proper ways to 
address. Local site (OKC) study personnel will recruit and consent provider participants and 
LAC members. The LSI (Sorocco) will be trained in the consent and enrollment process to 
ensure familiarity with study procedures. Ongoing, weekly team meetings will be conducted in-
person or via conference calls with local site study team members together with the main site 
project team to ensure study protocols continue to be followed consistently throughout the study 
 
5.4 Inclusion/Exclusion Criteria 
 
Provider Criteria 
All mental health clinicians at the 16 CBOC sites will be approached for inclusion in the study. 
Clinicians will not be restricted based on discipline or prior CBT experiences but will be 
expected to have an interest in obtaining training and willingness to use bCBT in their practice. 
As seen in our ongoing trial, we anticipate that nurses, social workers, psychologists, 
counselors, and physician assistants will participate. The only exclusion criteria for clinicians will 
be for those clinicians who are not appropriately authorized to provide psychotherapy as part of 
their scope of practice at the VA. 
Veteran Participant Criteria 

 
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Veterans with clinically significant symptoms of depression will be included after multiple 
"baselines" to ensure consistency of depressive symptoms (score of 8 or greater as reported on 
the PHQ-8 during the telephone screen and 10 or greater PHQ-9 during the baseline 
appointment). The PHQ-9 is the instrument of choice for the VA PC-MHI initiative (consistency 
of current practice) and is ideal for use as a monitoring measure for depression over time. 
The single inclusion criterion is that Veteran participants be current recipients of services at 
CBOCs associated with the Houston or Oklahoma City VAMCs. To increase generalizability, 
participants will be excluded only for factors that would render bCBT inappropriate for the CBOC 
setting, including: 1) cognitive impairment; 2) presence of bipolar, psychotic or substance-abuse 
disorders. 3) Veterans currently receiving psychotherapy WILL be excluded. Those receiving 
general mental health services, including antidepressant medications, WILL NOT be excluded. 
Local Advisory Council Participant Criteria 
Consented clinicians serving as providers of the bCBT intervention, administrative staff, and 
facility leadership at the 16 Houston and Oklahoma City CBOCs will be eligible for participation. 
CBOC clinicians who have declined to participate in the bCBT training program will not be 
invited. No contract CBOCs or contract employees will be approached.  
 
5.5 Study Evaluations 
 
Implementation Measures and Data Collection Schedule (Study Aim 1): A mixed-method 
formative evaluation (FE) will be utilized to assess the adoption potential of the bCBT clinical 
intervention and implementation strategy. As informed by Stetler et al.,39 FE will progress 
strategically through four phases over the course of the project as follows: 1) a developmental 
evaluation to adapt the proposed implementation strategy for CBOCs, 2) an implementation-
focused evaluation to refine the implementation strategy based on lessons learned from early 
adopters, 3) a progress-focused evaluation to assess implementation outcomes, and 4) an 
interpretative evaluation to engage key stakeholders to better understand the impact of the 
implementation strategy. FE will assess adoption, effectiveness, and implementation (fidelity), 
and will pay close attention to the processes, challenges/barriers, and patient, provider, and 
clinic needs related to the use of bCBT in the CBOC setting. Table 2 lists the formative 
evaluation phases, timelines, and methods. 
Quantitative Implementation Data: Adoption will be defined as the number of enrolled CBOC 
clinicians relative to the number of providers able to provide bCBT within their scope of practice. 
Adoption will include the number of CBOC clinicians who are approached, complete training, 
and engage in implementation facets. We will also examine the average number of sessions 
clinicians provide per patient. Clinician Adherence and Competence will be assessed using 
fidelity scores and summarized as descriptive data. Scores will be used to identify clinician 
strengths and weaknesses and will provide the basis for feedback provided to clinicians through 

 
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the bCBT mentors. Data will also be used to determine whether bCBT was implemented as 
intended. Clinician bCBT Training and Utilization: Clinician bCBT utilization will be collected 
using chart reviews as well as a series of clinician-based self-report measures. Chart reviews 
will be conducted for all bCBT-randomized Veterans. Clinicians will be provided with a note 
template to standardize documentation and improve data extraction. Chart review data will 
include treatment initiation, number of sessions, type of session (in-person or telephone), 
content of session (module selected), as well as other quality indicators of care such as 
timeliness of initial session and duration of time between sessions. Chart review data will be 
supplemented with clinician surveys to document the frequency of use of various bCBT 
procedures and techniques (in development; modeled after our prior bCBT training study24, 26).   
Qualitative Implementation Data Collection and Outcomes: Qualitative data collection will occur 
in the form of focus groups and individual interviews with CBOC and national stakeholders. 
Interviews and focus groups will seek to understand the perspectives of clinicians, 
administrators, patients, and national leaders about the process and experience of providing 
bCBT in the CBOC setting and to further understand the challenges and opportunities for using 
such treatments in the future. The guiding domains for the interviews and focus groups are 
based on the PARiHS and RE-AIM frameworks. Guides were created for each interview type 
(individual or group), formative evaluation stage, and stakeholder group (patient, clinician, 
administrator, leadership; see Appendix 7 for a detailed listing of the interview guides). All 
qualitative data will be collected by experienced qualitative researchers. Interviews and focus 
groups will be conducted by telephone. Although the developmental evaluation will include the 
PI (Cully) and qualitative methodologist (Martin) – all other qualitative data will be collected by 
Dr. Martin and a research assistant who will remain independent of the main study project to 
maintain data integrity and privacy. Thus stakeholders will likely have no prior professional 
interactions with the interviewer. All qualitative data will be audio recorded and transcribed, and 
interviewers will maintain field notes to document tone or affect that may not be apparent from 
the written transcript. It is anticipated that individual interviews will last between 30-45 minutes 
with some groups (clerks/staff and leadership) lasting 20-30 minutes. Focus groups are 
expected to take 1-1.5 hours.  
Developmental Evaluation: The aim of this evaluation is threefold: 1) to asses CBOC needs, 
barriers, and facilitators related to bCBT use 2) to refine the clinical and implementation 
approach for CBOCs and 3) to increase local and national stakeholder engagement. It is 
anticipated that CBOC leadership will be critical throughout the project. The team will use the 
developmental evaluations as a foundation for future relationship building and engagement of 
CBOC leadership. During months 1-6, the project team will develop a local advisory council 
(LAC) consisting of CBOC clinicians, administrators/clerks, and CBOC/Parent Facility 
leadership to assist with understanding the current needs of CBOCs in the use and delivery of 
psychotherapy. The LAC will react to and refine the bCBT clinical intervention and 
implementation strategies proposed by the study team to help ensure these methods are 
consistent with practice needs at the CBOC level. LAC members will be asked to participate in 
up to 3 45-minute telephone-based focus groups to provide insight into process improvements. 
These individual interviews will occur during months 2 (needs assessment), 4 (reaction and 

 
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suggested changes to the bCBT and implementation strategies), and 6 (final refinement of 
strategies for initial role out). The total time commitment for LAC members will be 135 minutes 
and over the course of 6 months. Also, during months 1-6, the project team will engage the 
national advisory council (NAC; see Table 2). Although NAC members will be available for 
individual consultation, the project team will host a telephone conference call (e.g. Live Meeting) 
during month 5 where members will be asked to react and comment on the proposed bCBT 
intervention and implementation strategies as refined by the LAC. The NAC will be asked to 
specifically comment on the implementation potential and consistency of the strategies with 
national VA initiatives. Feedback from the NAC will be fed forward to the LAC for the final LAC 
meeting at month 6. Focus groups and interviews will be audio recorded and facilitated by the 
study qualitative methodologists. Given the aims of this phase, qualitative analyses will identify 
important concepts using transcript summaries rather than a full coding strategy (defined by 
Curran et al).40 Summary data will be distilled after each focus group, and study team will use 
these data to refine the intervention and implementation materials. At the conclusion of the 
developmental evaluation, the clinical and implementation approaches will have been modified 
for initial use within the CBOC setting. 
Implementation-Focused Evaluation: The aim of this evaluation is twofold: 1) to collect initial 
data and feedback on the clinical and implementation approaches from initial adopters (e.g., 
clinicians and clinics) and 2) modify the implementation strategy to enhance bCBT use. The 
study will also engage incoming CBOC clinicians regarding their perceptions of organizational 
readiness to support the implementation of bCBT using the Organizational Readiness to 
Change Assessment (ORCA).41  After initial role out of the clinical and implementation 
interventions, the team will conduct an evaluation during months 12-15 to obtain preliminary 
data from local stakeholders (clinicians, administrative staff, leadership, and Veterans) about 
their reactions to the bCBT programming. The ultimate goal of this aspect of the formative 
evaluation is to discover any barriers that were not identified during the developmental 
evaluation. Should additional barriers be identified, the study team will work with stakeholders 
to modify the implementation approach. Quantitative data will be collected including: 1) clinician 
adoption rates, 2) clinician fidelity ratings, and 3) patient bCBT use (treatment engagement, 
completion, and number of total sessions attended). Qualitative data will be collected from 
bCBT clinicians (n = 3-4) and clinic administrators/leadership (n = 2) in the form of individual 
telephone interviews. Dr. Martin (qualitative methodologist) will lead all study interviews for this 
phase. In addition, a purposeful sample of Veterans (3-4) who received bCBT will be 
interviewed to elicit feedback on feasibility, acceptability, and meaning /impact. We will 
purposefully select Veterans based on engagement / completion rates to ensure diversity. 
Interviews will be audio recorded and transcribed into summaries (rather than full coding). 
 
Progress-Focused Evaluation (PFE): will 1) explore the impact of the bCBT clinical and 
implementation approaches; 2) assess factors related to using the implementation approach; 
and 3) produce a project summary document to be used during the interpretive evaluation 
phase. The PFE will occur at the beginning of year 3 when the majority of CBOC clinicians and 
clinics will have been recruited for the trial.  PFE will differ from the implementation-focused 
evaluation in that it will involve a larger number of CBOC clinicians and will occur after the 

 
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implementation strategy has been refined. The project will continue to use the ORCA with all 
incoming CBOC clinicians during this phase to enhance our understanding of organizational 
culture and needs. Quantitative data will include clinician and clinic adoption rates, clinician 
fidelity ratings, and bCBT utilization statistics. Qualitative methods will focus on bCBT 
implementation with particular emphasis on barriers, facilitators, and reaction to the 
implementation strategy provided by the study team. Individual interviews will be conducted 
with CBOC clinicians (n = 12-15), CBOC administrative staff (n = 4-5), and CBOC leadership 
(n = 4-5). We will also conduct individual interviews with Veterans (n = 9-12) who were 
randomized to the bCBT intervention. Veterans will be purposefully sampled according to bCBT 
exposure (no engagement, 1-3 sessions, and 4 or more sessions/completers). The study team 
will begin all interviews from a phenomenological perspective asking participants a broad, open-
ended question about their lived experiences with bCBT, probing the salient factors and 
processes identified. Interviews will transition into a semi-structured format to allow for the use 
of probes, as suggested by Patton 42,43 and informed by PARHIS and RE-AIM. Unlike the first 
two phases of formative evaluation, data collected from the PFE will be subjected to rigorous 
qualitative data coding and analyses. The study qualitative methodologists will then work with 
the larger study team to create a summary document for use during the interpretive evaluation. 
Interpretive Evaluation will occur during months 39-42 of the project and will seek to: 1) use a 
project data summary document to inform stakeholders (NAC and LAC) about preliminary study 
outcomes and 2) obtain stakeholder reflections on importance, meaning, and the potential for 
wider use of bCBT in CBOCs. To accomplish these goals, focus groups will be conducted with 
the NAC and LAC. Stakeholders will receive the project data summary document two weeks 
prior to their focus group. Focus groups will seek stakeholders’ reactions to the project data 
using open ended questions. Follow up questions will engage stakeholders in future-oriented 
inquiries about implementation and dissemination potential of bCBT in CBOC settings and will 
attempt to obtain consensus on next steps. Focus groups will be conducted by Dr. Martin and 
audio recorded. Analyses will use transcript summaries rather than full coding. Focus group 
data will be reviewed by the full team and used to inform dissemination of project materials, 
manuscripts, and grant planning. 
 
Table 2. Formative Evaluation (FE) Data Collection Timeline, Methods, Expected Outcomes 
 
 
 
 
 
 
 
 
 
 

 
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Effectiveness Measures (Study Aim 2): Measures were selected for their strong psychometric 
properties, ability to detect patient-centered change, and feasibility for adoption/implementation 
within VA (see Appendix 8 for a complete listing of all Effectiveness measures). 
Depression: Depression will be assessed using the Patient Health Questionnaire – 9 (PHQ-9) 
and the Beck Depression Inventory – Second Edition (BDI-II). Treatment response will be 
defined by a 50% reduction in depressive symptoms on both the PHQ-9 and BDI-II. 33-35 The 
PHQ-9 consists of the depression module from the larger, self-administered version of the 
PRIME-MD44 and is particularly versatile in its ability to assess both symptoms as well as each 
of the nine DSM-V depression criteria.36 For this study, a PHQ-9 cutoff score of 10 or greater 
will be used for inclusion criteria. Note: The PHQ-9 will be administered by study RAs and 
independent evaluators as part of all “study-based assessments” and will also be used by bCBT 
clinicians as part of their regular course of treatment with bCBT participants. The BDI-II, a 21-
item self-report instrument, will be used as a second measure of depressive symptoms. The 
BDI-II is psychometrically strong45 and is reliable, internally consistent, and valid for use in the 
primary care setting.46 The BDI-II will serve as a second measure of depression and, unlike the 
PHQ-9, will be administered exclusively by study staff. 
Quality of Life and Functional Status: Quality of life will be assessed using the 12-Item Short 
Form Health Survey for Veterans (SF-12V),47 an instrument adopted by VHA as a performance 
measure of functional status. The SF-12V is comprised of 12 items from the SF-36. The SF-12 
consists of two scores, physical (PCS) and mental (MCS) functioning. Covariates: Demographic 
data will include age, gender, ethnicity, income, marital status, education, employment, and 
distance from the VA and/or CBOC. Diagnoses of Anxiety and Depressive Disorders will be 
assessed using the MINI depression and anxiety modules. Coding of these variables will be 
dichotomized for each type of depressive and anxiety disorder assessed. PTSD will be 
assessed using the PTSD Checklist- Civilian Version (PCL-5), a standardized self-report rating 
scale that corresponds to DSM-IV symptoms of PTSD and possess strong psychometric 
properties.50,51 Comorbid Medical Conditions/Medical Complexity will be calculated using the 
Charlson Comorbidity Index (CCI) as defined by VA database extractions for the 12 months 
prior to the baseline date. The Charlson score has been widely used in the literature for 
assessing morbidity and mortality in a wide range of patients.52 The ICD-9 codes constituting 
each condition will be b a s e d  on those identified in Deyo’s adaptation.53 Co-existent Use of 
Psychotropic Medications will be collected to control for possible effects of ongoing 
pharmacologic treatment. VA databases and participant surveys will b e used to assess for the 
presence of mental health medications. The study team has experience evaluating the impact 
of psychotropic medications in psychotherapy trials and has also conducted several VA 
database studies looking at the impact of antidepressant medications on depression care 
quality.8, 54 Dr. Kunik (psychiatrist and Co-I) will lead efforts related to psychotropic medication 
tracking which will include information on start date of medication, dose, and days’ supply. 
Medication use will be coded for presence or absence, changes to type or dosage, as well as 
medication possession ratios (days of medication relative to time frame of medication 

 
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treatment). Antidepressant medications will be evaluated in both the treatment and usual care 
groups at all assessment time points, affording the study an opportunity to evaluate whether 
assignment to the treatment group impacted receipt of medications. Participant self-report data 
will allow for global estimates of non-VA medication use. Health Service Use: Health-service-
use will be collected for each participant to control for non-study encounters and healthcare 
services. Service use will be collected from VA medical records as w e l l  as a patient self-
reported non-VA service-use questionnaire. Health service information will be collected via 
VHA national and regional databases. The study team will obtain all relevant approvals (e.g. 
DART) prior to data extraction. Data will be collected on the frequency and type of inpatient 
hospitalizations and outpatient medical and mental health encounters. Outpatient mental health 
care use will be monitored and used as a covariate. 
Treatment Variables Intensity/dose of bCBT will be defined as the total number of sessions 
attended. Session (telephone/in-person) and module type will be collected to examine for impact 
on outcomes. These data will be collected via note templates and chart review procedures 
using CAPRI. Treatment Expectancy will be assessed using the Expectancy Rating Scale 
(ERS).55 The ERS includes 4 items that assess how logical treatment seems, the patient’s 
confidence undergoing treatment and recommending it to others, and expectations for 
treatment’s success. Therapist Rating of Patient Engagement and Adherence will be collected 
following the last session of treatment. 
Therapists will be asked to rate the overall level of patient engagement and adherence (2 items), 
using a 10- point Likert-style format, ranging from not at all engaged/adherent to fully 
engaged/adherent. Working Alliance will be assessed using patient and therapist report forms 
of the Working Alliance Inventory - Short Form (WAI-S). The WAI-S consists of 12 items and 
yields an overall score and 3 subscale scores, has adequate internal consistency, good overall 
validity, and is predictive of reduction in depressive symptoms. 
Secondary Measures: To better understand factors that may contribute to participant treatment 
response, the protocol has been expanded to include brief assessments for the following: 
insomnia, pain, illness intrusiveness, CBT skill acquisition, personality, social support, 
attachment style, life purpose, and Veterans perceptions. Careful consideration has been taken 
into selection of the measures, as not to add any undue burden on participants. 
 
Effectiveness Data-Collection Schedule: Data will be collected over 12 months posttreatment 
to examine long-term effects/decay of the intervention (see Table 3). An initial telephone 
assessment will screen for exclusion criteria, with final eligibility determined at the baseline 
appointment. Four-, eight-, and twelve-month follow-up assessments will be conducted by 
blinded independent evaluators. A 90 minute time limit has been established for all assessment 
interviews in order to reduce burden on Veteran participants. For participants that do not 
complete all study measures during the 90 minute assessment period, participants will be 

 
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reminded that they have completed their participation.  They will be provided with the option to 
end the call or continue the interview – not to exceed 120 minutes in total time.   
Table 3. Assessment Schedule – Effectiveness Data 
 
 
 
 
 
 
5.6 Data Analysis 
 
Sample Size and Power Calculations:  
Provider Sample (Implementation Data; Aim 1) 
No formal sample size calculations were used for the implementation-focused elements of this 
project. Rather, the team will invite all CBOC providers at all sites within the HOU and OKC 
VAMCs to participate and subsequently evaluate how many providers opted to engage in the 
bCBT project. These procedures are common for implementation-focused trials that often have 
a smaller pool of “subjects”. Designs of this nature often look less at statistical significance and 

 
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instead focus more on descriptive quantitative data and depth interviewing and qualitative 
analyses to determine impact and “lessons learned”. 
Veteran Sample (Effectiveness Data; Aim 2) 
Sample-size calculations indicate that 232 patients will need to be randomized to address the 
primary hypothesis for aim 2. Based upon our current project, we will need to recruit 300 Veterans.  
Approximately 30% of recruited participants were screened ineligible due to subthreshold anxiety 
and/or depression scores.   
We will use unequal randomization to reduce unnecessary recruitment, resulting in 138 patients 
for bCBT and 94 for EUC. In determining the sample size, we first determined the number of 
participants needed to have 80% power to detect significant differences in the primary 
outcomes between our groups. We then inflated this to account for intraclass correlations 
among patients and for attrition and loss to follow-up. A sample size of 70 patients in both the 
bCBT and EUC groups (140 total) is needed to detect a difference in the means of the primary 
outcome that reflects a small effect size of .30, using a 2-sided t-test with 80% power at the .05 
significance level, adjusted for repeated measures.56 The small effect size was chosen to 
ensure an adequate sample size to address multiple study aims and outcomes. The bCBT 
sample size was then inflated by [1 + (m - 1) c] to account for the intraclass correlation due to 
clustering of patients within bCBT clinicians.57 Based on the sample size of 70 bCBT patients, 
an average of 5.8 patients per therapist, and an assumed correlation, c, among patients of 
.10,57 our inflation  factor is 1.48 (70 x 1.48 = 104). A clustering inflation factor was not used for 
the EUC group. Both the bCBT and EUC groups are inflated to account for attrition rate at 12 
months of 25%. 
Unequal numbers of patients per group offers the advantage of reduction in unnecessary 
recruitment. We will have 80% power to detect a clinically important difference in means on the 
PHQ-9 between the intervention and usual care groups that is as small as 1.83, based on a 
small effect size of .30 and estimates of the pooled standard deviation of 6.1.58 Lowe concluded 
that differences in PHQ-9 scores of 5 or greater reflect a clinically relevant difference. 
Similarly, we can detect differences in the means of the BDI between the treatment and EUC 
arms as small as 3.6 units, assuming a standard deviation of approximately 12 as seen in Kunik 
et al. 2008.31   Assuming mean baseline BDI values of 20 or higher,31 we will have more than 
80% power to detect a 50% reduction in BDI. For quality of life as measured by SF-12, a 
difference of one-half standard deviation (i.e., 5 points) is considered clinically significant.48 On 
the basis of the standard deviation of the Mental Component Summary score (MCS) from Kunik 
et al.31 of 14.7 and from Hendrick et al of 11.5, we will have 80% power to detect a difference in 
MCS scores as small as 3.45. For the SF-12 Physical Component Summary score, assuming 
standard deviations of 11 and 12 we can detect a difference in means as small as 3.3 points. 
Therefore, we will have more than 80% power to find clinically significant differences in quality 
of life. 

 
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Patient Availability: CBOCs in Houston and Oklahoma City care for a large (n = 50,000+) and 
diverse Veteran population. We estimate a sample of 7,500 assuming a 15% rate of elevated 
depressive symptoms. 
Minimization of Attrition: Improved engagement and retention of participants may be 
challenging for Veterans cared for in CBOC settings but our experiences using telephone-based 
recruitment procedures in prior trials have been highly successful. A 25% attrition rate was 
used for study-power calculations, which is slightly above our current trial’s attrition rate of 22%. 
Dropouts will include any participants who indicate a desire to withdraw from the study following 
random assignment. Reasons for study discontinuation will be recorded for subsequent 
analyses; and overall attrition rates will be examined as a primary study aim. The current 
proposal employs a flexible intervention approach, using individual sessions and telephone 
encounters to decrease attrition and improve participant engagement and adherence to 
treatment. We will also minimize attrition by reducing our “research presence" by using 
telephone assessments and limited research contact following randomization, and modestly 
compensating participants for their time. Additionally, Veterans that become difficult to contact 
via telephone will be mailed an unable to reach letter to encourage them to contact the study 
(see Appendix 10). The letter will explain the team’s efforts in trying to contact them and ask 
the Veteran to follow up with study staff to schedule an appointment.  
Note: bCBT patients who drop out of treatment will be allowed to continue with research follow-
up assessments.  
Analyses:  
Aim 1 analyses will use data from the mixed-method formative evaluation described above. 
Quantitative analyses will use descriptive data related to clinician adoption, fidelity ratings, and 
bCBT utilization (participant engagement, treatment completion, and total session exposure). 
Data will be compared to our prior work to explore if differences exist between VA hospitals 
(HOU and OKC) and the CBOCs engaged in the current proposal. We will also use VA 
databases to explore the use of psychotherapy services pre- and post- implementation using 
depression ICD-9 and psychotherapy CPT codes as used by the PI in prior work.15.59 Qualitative 
data for aim 2 will use a combined inductive and deductive analytic approach given our desire to 
understand the firsthand accounts of stakeholders (inductive) while incorporating a priori codes 
using elements from our implementation frameworks (deductive). The analytic approach will 
examine interview and field-note data from patients, providers, clinic leaders, and leadership. 
This entails examining the textual data from the insider’s perspective to uncover patterns in the 
experiences under investigation.43, 60-62 The result is the description of a deeper structure, a 
synthesis of the data into one explanatory framework.62 Field notes and transcripts will be read 
and re-read, and key terms coded. Initial coding will identify significant statements, sentences, 
or quotes that provide an understanding of how the participants experienced/used bCBT. Study 
coders will develop clusters of meaning or themes to produce a written description of the 
contextual elements. Coding will culminate in a codebook that includes a narrative of the central 

 
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themes with illustrative quotes, along with a visual portrayal of the data including the factors 
and outcomes related to the central phenomenon. 
The above listed coding methods will be used during the progress-focused formative evaluation. 
A briefer coding method will be used during other formative evaluation phases. These less 
rigorous coding strategies, informed by Curran et al, fit well with the focused aims of the 
formative evaluation phases and are seen as critical to ensure project feasibility. Coding will be 
conducted by a qualitative investigator at the Houston HSR&D CoE (Martin). Dr. Martin, a 
medical anthropologist, will lead the qualitative inquiry. She will collaborate with Dr. Curran 
(senior consultant and co-I) and coordinate coding procedures with the study team.  
Aim 2 will determine whether depression and quality of life outcomes differ as a function of the 
intervention at posttreatment, and at 8- and 12-month follow-ups. All analyses will be done on an 
intention-to- treat basis. Following the recommendation of the CONSORT group, we will not test 
for differences in baseline characteristics or adjust subsequent analyses for any variables we 
did not decide a priori to include in the regression models.63 To compare changes between the 2 
groups over time, we will use a longitudinal, mixed- model analysis containing terms for the 
intercept, treatment, time period and interaction between time and treatment. Separate models 
will be run for each outcome (PHQ-9, BDI, SF-12 PCS and MCS) and for the combined outcome 
of whether or not the patient responded to treatment as measured by both a 50% reduction in 
PHQ-9 and BDI-II. Linear regression will be run for the continuous outcomes and logistic 
regression will be used for the combined depression outcome. We will include the use of 
antidepressant medications, receipt of outpatient mental health care, the modality of treatment 
(e.g., telephone, in-person, combination), and the stratification variable, site, in the analyses to 
control for any possible differences that might exist between the treatment arms that might 
impact our outcomes. The interaction between time and treatment will indicate whether there is 
a difference over time between the 2 groups. We will conduct sensitivity analyses to evaluate 
whether the reasons for loss to follow-up at the various time periods are related to the observed 
values of the outcome variable, using tests for missing completely at random and tests for 
nonrandom missingness.56  
Analyses for Aim 2 will occur exclusively at the Houston HSR&D CoE under the direction of the 
PI (Cully), study statistician (Co-I Petersen), and study data analyst (Sansgiry). 
Other analyses: Prediction of bCBT Treatment Response: We will use multivariate analyses to 
predict treatment response in the bCBT group, defined as 50% or greater reduction in PHQ-9 
and BDI scores from baseline to posttreatment. Variables will include patient demographic and 
clinical characteristics (e.g., baseline depression severity, mental health comorbidities, 
treatment expectancy), as well as treatment (number of sessions attended, therapeutic alliance, 
patient engagement) and clinician factors (e.g., clinician adherence/skillfulness). Depression 
Treatment Intensity: Within the bCBT treatment group, the study team will evaluate the 
associations between depression-symptom response and treatment intensity (number of 
sessions).We will explore potential patient demographic and clinical characteristics associated 
with treatment response and intensity. Further, we will use surveys and qualitative interviews 

 
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with clinicians and bCBT participants to more fully understand whether the treatment intensity 
received was the treatment believed to be ideal. Perspectives from both patients and providers 
will be needed to fully understand this construct. 
All exploratory analyses will occur exclusively at the Houston HSR&D CoE under the direction of 
the PI (Cully), study statistician (Co-I Petersen), and study data analyst (Sansgiry). 
 
5.7 Withdrawal of Subjects 
 
There is no foreseeable circumstance for which research participants will be withdrawn from the 
study without their consent. If a participant chooses to withdraw from the study, there will be no 
consequences. The subject will not lose any rights or permissions s/he currently receives. To 
withdraw from the study, an individual will be asked to contact the study staff to inform of the 
decision and remove their participation status in the project databases. 
6.0 
Reporting 
 
All unanticipated serious adverse events (U-SAEs) and unanticipated serious problems (UAPs) 
will be reported to the VA Central IRB within five business days. U-SAEs will be reported to VA 
Central IRB regardless of their relationship to the research. All protocol deviations, violations, 
and/or noncompliance will be reported to the VA Central IRB within five business days of the 
reporting individual becoming aware of the occurrence. 
Safety information, including SAEs/UAPs, that will be collected:    
Safety information will be monitored for all participants over the course of the study. Participants 
demonstrating increased depression symptoms as reported on the PHQ-9 (a 5-point increase) 
from baseline will be evaluated and referred for additional assessment and intervention as 
needed. Participants in need of immediate treatment (e.g., active psychosis or suicidal intent) 
will be referred for appropriate services with VA upon identification. Study staff will follow up on 
any positive responses to items involving suicidal thinking, using a structured crisis-assessment 
protocol (see Appendix 3). Participants who express suicidal ideation will be forwarded to a 
study investigator who will triage and refer for care as appropriate.  
All occurrences of events resulting in a participants’ death, life threatening experience, 
hospitalization, prolonged hospitalization, or persistent or significant disability will be 
documented. Any occurrence of an event that results in the need for medical or other 
interventions to prevent any of the above listed outcomes will be documented as well. As such, 
any participants identified as having an immediate mental or physical health issue will be 
referred to care as appropriate.  

 
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Frequency/methods of safety-related data collection:   
Collection of safety information will commence when the first participant is enrolled in the study; 
this is anticipated to occur during March 2015. Safety information may be collected either 1) 
during baseline and follow up assessments, 2) during bCBT sessions, or 3) during telephone 
contacts with participants made for purposes of scheduling assessments and/or treatment 
sessions. All participants will complete comprehensive assessments via telephone at baseline 
and at 4-, 8-, and 12-month follow-ups. Symptoms of depression and suicidal ideation will be 
assessed at these time points. Secondly, those participants assigned to the bCBT group will 
complete measures of depression during each session with their study clinician; these sessions 
will occur either in person or over the telephone depending on patient preference. Third, the 
Research Coordinator or RA will periodically contact patients to schedule study-related 
appointments. The participants or other informants may report information related to their safety 
at those times.            
Conditions that would trigger an immediate suspension of the research:   
This intervention will compare a brief, structured cognitive-behavioral intervention with usual 
care practices in VA CBOCs. The active treatment, bCBT, utilizes well-established 
psychotherapeutic techniques to enhance patients’ self-management of mood and physical 
functioning. No medications, invasive procedures, or untested techniques will be used. As such, 
this protocol is judged to be of low risk. We do not anticipate the occurrence of events that 
would necessitate the immediate suspension of research because of 1) the low probability of 
adverse events from the intervention in either arm of the study, 2) all participants will continue to 
receive usual care services within the VA, and 3) treatment for depression will not be withheld 
from any participants.  
Specify procedures to determine when and how to notify individual participants or their health 
care providers of findings that may affect the participant’s health or welfare: 
The decision to contact a patient and/or their health care provider regarding patient welfare can 
be made in two ways. First, the Project Coordinator, RA, or independent evaluators will conduct 
routine checks on participants’ safety and well-being, including an assessment of suicidal 
ideation, during baseline and follow up assessments. These study personnel will notify the 
patient and/or their healthcare provider as necessary.  
Second, data and safety monitoring is expected to be conducted at both the local and national 
levels. At the local level, the study PI (Cully), site PI (Sorocco), co-investigators (Stanley, Kunik, 
Kauth) will work with the study programmer and statistician to review data and safety issues 
regularly during monthly investigator meetings or more immediately as needed. Data and safety 
monitoring will occur for any identified adverse events as well as including a regular monitoring 
schedule of participant longitudinal data. Any participants identified as having an immediate 
mental or physical health issue will be referred to care as appropriate. Participants will also be 
monitored for increases in symptoms of depression. All participants, regardless of treatment, 

 
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with a 20% increase in symptoms (relative to baseline) will be called to ensure safety and 
encourage the participant to obtain care if desired. 
At the national level, the study has been approved by the VA's Data and Safety Monitoring 
Board (DSMB). We will continue to provide the national DSMB with comprehensive annual and 
semi-annual reports for formal independent review of study safety and recruitment practices. 
 
7.0 
Privacy and Confidentiality 
 
Protected health information (PHI) obtained from patient participants will include:  name, age, 
date of birth, home address, contact phone number, last 4 digits of their social security number 
(which allows us access to their medical record). PHI requested from enrolled clinicians will be 
restricted to their name. Information obtained about participants (veteran and clinician) will be 
kept strictly confidential and not disclosed. 
 
Each participant (veteran and clinician) in the study will receive a unique ID number to increase 
confidentiality. Data obtained from participants will be maintained in a password protected 
electronic database. Data and audio recordings will be limited to the study team and stored on 
VA computers (behind the VA firewall) under Drive:M. As another level of security, access to 
study folders will be restricted to study team members listed on the delegation of authority. In 
addition, all electronic data files will be password protected for additional security. To maintain 
privacy, assessments and interviews will be conducted in one of several private interview rooms 
available or in the study staffs’ office. Private interview rooms will be scheduled for use at the 
time the assessment is scheduled. Clinician consent forms will be kept in a locked cabinet, 
housed in a data storage room that has a security keypad as entry. All electronic data files will 
be maintained within the VA setting and behind the VA firewall. The file cabinet is in room (212) 
located in the John P. McGovern Campus (Nabisco building), Suite 01Y. Access to research 
records will be restricted to the PI and his project staff.  
All project staff are required to have undergone focused training on privacy, the protection of 
human subjects, research methods and the importance of integrity in the research process.  
Houston VA HSR&D IQuESt Computing Center also requires all project staff to review the Data 
Secutrity Compliance Agreement which describes the center’s data security protocol. Each 
project staff member must sign an acknowledgement that they have reviewed the policy and 
agree to follow the policy before accessing data. The Houston VA HSR&D IQuESt Computing 
Center data security policy conforms with current VA policies and has been reviewed and 
approved by the MEDVAMC Chief Information Officer, Information Security Officer, and Privacy 
Officer. 
 

 
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8.0 
Communication Plan 
 
Plan for engaged facilities: 
o Upon approval of the PI/SC application Form 108, each local site will submit VA Central IRB 
Form 104 (Local Site Investigator Application), which must be signed by the Local Site 
Investigator, his/her supervisor, and the local site ACOS/R&D or Chief of Staff. 
o Upon VA Central IRB approval of the Form 104 Local Site Investigator Application, the local 
site R&D Committee must provide written approval for the research to be conducted at the 
local site before the research begins.  
o The Project Coordinator will maintain copies of the local site R&D Committee approvals in 
the main site regulatory binder. 
o Local site Investigators or their designated study team member Research Assistants (RAs) 
will maintain copies of the main site approval, as well as the local site R&D Committee 
approvals in their respective local site regulatory binders 
Plan for non-engaged facilities: 
This research study will not take place at any facility not engaged in the research (i.e., without a 
Local Site Investigator Project Application approval). 
Plan for notifying and obtaining local site approval of amendments and other 
administrative changes: 
o Upon VA Central IRB approval of all PI/SC Amendments and Local Site Amendments 
(including modifications to the protocol, the procedures for verbal informed consent and 
HIPAA authorization, and any administrative change approvals), the Project Coordinator will 
send an electronic copy of the approval and all attachments via email to the Local Site 
Investigator to submit to the local site R&D Committee for approval (when required by the 
local site RDC). 
o The Project Coordinator will maintain copies of all approval documents, including local site 
R&D Committee approvals (when required by the local RDC) in the main site study binder.  
o The local site Investigator or local site RA will maintain copies of all PI/SC Amendments and 
Local Site Amendments (including modifications to the protocol, the procedures for verbal 
informed consent and HIPAA authorization, and any administrative change approvals) that 
pertain to their respective site in the local site regulatory study binders.  
o The local site Investigator or local site RA will maintain copies of their respective local site 
R&D Committee approvals (when required by the local site RDC) in their local site study 
binder. 
o When the local site R&D Committee requires approval of amendments and/or administrative 
changes, no change will be implemented prior to receiving documentation of the approval of 
the local site R&D Committee. 

 
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Plan for keeping all engaged sites informed of changes to the protocol, informed 
consent, and HIPAA authorization: 
A. Regular meetings and conference calls:  The PI will lead regular conference calls and 
meetings that will include discussions of changes to the protocol, informed consent process 
and the HIPAA authorization.  Study team members will be notified through these 
conference calls and meetings of upcoming changes, as well as when the PI receives 
notification from the VA Central IRB of final approval of such changes. 
o The PI will lead weekly meetings to discuss the study status with the study 
leadership team (select co-Investigators, Project Coordinator, and other study team 
members)  
o The PI will lead weekly conference call discussions with the Local Site Investigator 
and her study team. 
o The PI will lead monthly meetings in person and via conference calls to provide 
status update/discussions with all co-Investigators, Local Site Investigator, and all 
local site study team members 
 
B. Shared drive: The Project Coordinator will maintain a shared drive on the Houston VA 
HSR&D IQuESt secure server (that resides behind the VA firewall) that is accessible to local 
site study team members. The Project Coordinator will maintain the most current version of 
all IRB approved documents on this shared drive. 
o When new or revised documents are submitted for approval, the Project Coordinator 
will notify the Local Site Investigator and her study team that changes have been 
submitted for approval and are under review by the VA Central IRB.  
o Upon VA Central IRB approval of a new or revised form, the Project Coordinator will 
notify the Local Site Investigator and her study team that the new form has been 
approved. The PI or the Project Coordinator will provide training on newly approved 
procedures to all local site study team members. 
o All local site personnel will be asked to do the following: 
• 
File a printed copy of the VA Central IRB approval, and all newly approved 
documents, in the local site study binder. 
• 
Destroy all blank supply copies of previously approved versions of any newly 
approved study forms. 
• 
Begin using the new form, or applying the newly approved procedure, 
immediately. 
 
 
Plan for informing local sites of any Serious Adverse Events, Unanticipated Problems, or 
interim results that may impact conduct of the study:  
• 
The Project Coordinator will notify all participating sites immediately of any SAEs, 
Unanticipated problems, or interim results that have the potential to affect 
implementation of the study. A copy of the SAE report or Protocol Deviation report that is 

 
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submitted to the VA Central IRB will be sent to the Local Site Investigator, as well as 
their local site study team members via encrypted email. Additional copies will be sent to 
the local site R&D Committees. 
• 
The PI will discuss SAEs, Unanticipated Problems, Protocol Deviations, and interim 
results that may affect the conduct of the study during the weekly and monthly, 
meetings. 
 
Plan for ensuring the study is conducted according to the IRB-approved protocol: 
 
• 
The importance of conducting the study according to the IRB-approved protocol is 
emphasized by the PI to all study team members on a regular basis. In particular, all 
research team members are required to read the IRB-approved protocol (and any 
subsequent amendments), and research staff will receive specific training from the PI or 
Project Coordinator regarding protocol elements relevant to their study role before their 
involvement in the study begins. This study-specific training is over and above the 
mandatory trainings that all research staff receives.   
• 
During weekly and monthly meetings, the PI will follow-up with the LSI to ensure that she 
continues to adhere to the protocol and to standard research compliance procedures as 
required by the VA. 
• 
The PI will require the LSI to hold weekly or bi-weekly meetings with their respective 
local site study teams 
 
Plan for notifying all local facility directors and LSIs when a multi-site study reaches the 
point that it no longer requires engagement of the local facility (e.g., all subsequent 
follow-up of subjects will be performed by the PI from another facility): 
 
• 
The PI will notify the LSIs when the study reaches the point at which it no longer requires 
engagement of the local facility. 
• 
The LSIs will submit Form 117b Local Site Project Participation Closure Report to the PI, 
who will submit the signed form to the VA Central IRB. 
• 
The LSI will notify their respective local site Facility Director and R&D Committee that 
their facility will no longer be engaged in the research.  
 
9.0 
References 
 
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(3) Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-
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(6) Lowe B, Schulz U, Grafe K, Wilke S. Medical patients' attitudes toward emotional 
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(7) Wray LO, Szymanski BR, Kearney LK, McCarthy JF. Implementation of primary care 
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(8) Stanley M, Wilson N, Novy D et al. Cognitive behavior therapy for generalized anxiety 
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