A Feasibility Study of Behavioral Activation in the Rehabilitation of Veterans With Post-TBI Depression
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: VA Office of Research and Development

 
 
 
 
A Feasibility Study of Behavioral Activation in the 
Rehabilitation of Veterans with Post-TBI Depression 
 
 
PI: Helene Moriarty, PhD, RN, FAAN 
NCT04976621 
 
 
Human Participant Information and Protocol Summary Excerpted from IRB 
approved Form 101, V. 6.0, Jan. 18, 2023, Approved by CMCVAMC IRB on 
3/6/2023 
 

Section 5: Human Participant Information 
NOTE:  A participant is considered “enrolled” at the time the consent is signed so this number should 
include an allowance for screen failures prior to randomization.  
 
1. 
How many participant records will be reviewed PRIOR to enrollment/consent occurring?  
We may review up to 300 records and send up to 300 letters in order to obtain a sample of 40 
subjects. 
 
2. 
How many participants will be screened PRIOR to enrollment/consent occurring? 
We may conduct Phone Screens on up to 300 potential subjects (however it is most likely that 
we will screen about 70). 
 
3. 
How many participants will be enrolled (total number to include randomized and screen 
failures AFTER consent is obtained)? 
60 
3.1. 
Will all research activity be the same at all sites?  Yes 
     No 
     N/A 
 
3.2. 
If no, please describe the activity that is different or limited (For example; 2 sites will 
analyze data only, or, 1 site will consent and enroll all participants etc.):        
 
4. 
Are there any further screening procedures after enrollment?  Yes 
     No 
 
4.1. 
If yes, describe:  Screening for the inclusion criteria on the CES-D and PHQ item 9 and 
exclusion criteria for the person with TBI (presence of psychosis, presence of asphasia, PHQ-
9 affirmative response on item 9 indicating suicide ideation, or indication of dementia  based 
on difficulty responding to interview questions will occur after consenting.   
 
5. 
Are non-Veterans being enrolled?  NOTE:  This does not include non-Veterans enrolled at 
non-VA sites.     Yes 
     No 
 
5.1. 
If yes, provide justification.        
      NOTE: 
➢ Every non-Veteran should sign VA form 10-0483, Acknowledgement of the Notice 
of Privacy Practices (ANOP) 
➢ Once the ANOP is signed, the research study staff must send the non-Veteran's 
name to the CMCVAMC Privacy Officer via encrypted e-mail.  The signed ANOP 
must be kept in the research study binder. 
➢ If an oral informed consent is used, the NOP should be sent to the non-Veteran 
via postal mail.  In addition, the research study staff must write a Note-to-File that the 
NOP was sent to the non-Veteran. 
                
6. 
Does this project target a specific race, gender or ethnic group as participants?  
     Yes 
     No 
     
6.1. 
If yes, indicate which group and why this group is being targeted.   
               
 
7. 
What is the age range of participants?  (Check all that apply.) 
Neonates (See note below) 
 
Children Under 18 (See note 
below)  
 
Young Adults (18-21) 
 
Adults (22-65) Age 21 allowed 
 

Seniors (Over 65) 
 
       NOTE:   If neonates or children is checked, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children.  Only non-invasive monitoring 
and/or prospective observational and retrospective record review studies that are minimal risk can 
be conducted in VA involving neonates. 
 
8. 
Does the project involve the potential enrollment of any of the following populations or 
categories of participants?  That is, are you targeting a specific group.  NOTE:  These 
populations must be checked “Yes” if they are not being excluded from the research. 
 
Yes        
No     N/A 
a.  Employees  
 
 
 
b.  Students at the VA or Penn 
 
 
 
c   Individuals with impaired decision-making capacity   
 
 
 
d.  Pregnant women (See below) 
 
 
 
e.  Economically and/or educationally disadvantaged persons 
 
 
 
f.   Prisoners  (See Below) 
 
 
 
g.  Illiterate, limited, or no English language proficiency 
 
 
 
h.  Terminally ill patients 
 
 
 
i.   Children (See Below) 
 
 
 
 
  
 
 

16: Protocol Summary 
 
1. 
Introduction 
1.1. Provide scientific background and rationale for study.   
Since 2000, 379,519 U.S. service members have been diagnosed with TBI, representing up to 22% 
of combat casualties.1 In addition, many veterans of earlier wars have remote TBIs only recently 
diagnosed, the result of increased awareness of TBI in the Veterans Health Administration (VHA) and 
the general medical community.2 Depression is one of the most common psychiatric sequela of TBI,3,4,5  
with prevalence estimates up to 53% for major depressive disorder (MDD).6,7 It is also among its most 
serious sequelae. Post-TBI depression may interfere with rehabilitation effectiveness8 and treatment 
adherence;9 impede reintegration into family and community;10,11 and lead to lower quality of life and 
functioning,12,13 lower rates of return to work, problems in interpersonal relationships, and heavier 
caregiver burden.3 Research documents a strong link between TBI and suicide risk.14,15,16 Compared to 
the general population, individuals with TBI are at greater risk for depression and suicidal behavior, and 
risks of both remain elevated for many years.17,18,19,20  Yet, post-TBI depression tends to be under-
assessed and undertreated.21 In light of this, the paucity of intervention research on post-TBI 
depression is remarkable.6,22  
     In the absence of RCT-based clinical guidelines for the treatment of post-TBI depression, current 
treatments are based largely on expert opinion rather than evidence from controlled trials.23 The 
treatments most used for TBI depression are medication24,25 and cognitive behavioral therapy 
(CBT).26,27,28  Each approach has shortcomings for post-TBI depression. Many people prefer not to take 
medication, cannot tolerate its side effects, or fear stigma from seeking traditional treatment in specialty 
mental health programs.29 These constitute barriers to pharmacological treatments. CBT also has 
significant limitations as a treatment for post-TBI depression. First, CBT depends upon cognitive work. 
It is based on the premise that behavior is closely linked to the way individuals perceive and think about 
their situation; thus, therapy targets maladaptive thinking to improve mood and functioning. Yet, many 
of TBI’s hallmark deficits - especially in memory, organization, planning, and initiation - may interfere 
with the cognitive work that CBT requires. Second, CBT depends on the availability of mental health 
professionals with specialized training in CBT, and these providers are not always present in 
rehabilitation settings.  
      
1.2. Include summary of gaps in current knowledge, relevant data, and how the study 
will add to existing knowledge.   
Gaps in Current Knowledge. The absence of optimal evidence-based treatments for post-TBI 
depression justifies clinical research on promising treatment approaches that can be folded into TBI 
rehabilitation services, increasing its accessibility and potential for uptake. The proposed study will 
test the feasibility of behavioral activation (BA),30,31 a well-established and empirically validated 
treatment that has its roots in CBT.32 Rigorously tested in clinical trials since the 1970s,33 BA’s 
efficacy has been demonstrated in trials to reduce or prevent depression in several clinical 
populations (cancer,34 macular degeneration,35 diabetes,36 PTSD,37,38) and to improve functioning in 
depressed older African Americans39 and African Americans with mild cognitive impairment.40 BA 
differs from CBT-based therapies in ways that improve its fit to post-TBI depression and its potential 
for uptake in a rehabilitation setting. BA is a brief behavioral treatment that helps people define goals, 
create and execute plans to attain them, and engage in meaningful activities - especially those that 
maintain or restore social roles that may be disrupted by TBI. Plan making has a preeminent role in 
social science,41 and interventions that promote planning have been effective in improving health 
behaviors.42 Because TBI may impair the capability to plan,43 interventions that enhance it are 
especially relevant for rehabilitation. BA protocol components therefore emphasize goal setting 
(especially for activities that promote social connectedness), creation of a plan (broken down into 

steps), strategies for implementation of the steps, identification of potential barriers, tactics to 
overcome them, activity monitoring and scheduling, and emotional regulation strategies. BA has 
rarely been used or studied for treatment of depression in a TBI population.44,45  
Relevant data. Our previous R21-funded RCT with military veterans with TBI revealed a high 
prevalence of depressive symptoms, with 89% of veterans scoring at or above the cutoff for clinically 
significant depressive symptoms.46 Several of our studies based on that R21 highlight the key role of 
depression in important outcomes.47,48,49,50  
(1) Community reintegration. Our first study of predictors of CR in veterans with TBI tested 
sociodemographic characteristics, family factors, physical factors, pain, PTSD, time post-TBI, and 
depressive symptoms. Multiple regression revealed depressive symptoms to be the sole independent 
predictor of CR.49  
(2) Depression as mediator of other effects on CR. This study 46 found depressive symptoms to totally 
mediate direct effects of both PTSD and physical functioning on CR. Such findings argue for targeting 
depression as a means of improving CR, enhancing rehabilitation effectiveness, and promoting other 
important outcomes.  
(3) Employment. Our study of employment status in veterans with TBI50 examined potential predictors 
of employment and found it associated with pain, depressive symptoms, and poor physical functioning. 
Physical functioning mediated the effect of pain, and depressive symptoms mediated the effect of 
physical functioning. 
(4) Mediation of treatment effects on depressive symptoms by activity engagement. A home-based, 
family-inclusive intervention, the Veterans’ In-home Program (VIP), was designed to target the home 
environment to align its social and physical demands with the veteran’s TBI-related strengths and 
deficits. In a 2-group RCT, VIP was compared to usual care on several 4-month outcomes.47 A 
secondary analysis51 examined depressive symptomatology and tested activity engagement as a 
mediator. The study showed an effect of the VIP on depressive symptoms, with VIP participants scoring 
significantly lower on the CES-D at follow-up than controls. Activity engagement at follow-up reduced 
this direct effect to nonsignificance. This suggests that the VIP intervention’s impact on depressive 
symptoms was attributable to increased activity engagement.  
     In summary, prior research indicates that (1) depression is prevalent among veterans with TBI; (2) it 
interferes with CR and employment outcomes; (3) BA is an effective therapy for depression in other 
clinical populations; and (4) BA is effective with populations having cognitive impairments. These 
findings justify moving forward with a pilot RCT to assess BA’s feasibility with veterans with TBI in a 
rehabilitation setting.  
How the proposed research would add to existing knowledge.  The proposed research will develop 
the BA protocol and measures and provide preliminary data for a larger-scale efficacy trial of BA. This 
line of research has the potential to add a powerful clinical tool for treating depression in VA 
rehabilitation settings and, thereby, improve access to an important form of care for veterans with post-
TBI depression. Furthermore, the research has the potential to enhance community reintegration of 
veterans with TBI, the ultimate goal of rehabilitation and a critical priority for the VA health system. 
 
1.3. Include rationale for including or excluding certain populations – in particular 
vulnerable populations. 
     We are not including vulnerable populations as defined by NIH.  
 
2. 
Objectives 
2.1. 
Describe the study’s purpose, specific aims, or objectives.  
The proposed pilot study is designed to test the feasibility of delivering BA for 
post-TBI depression in the VA rehabilitation setting. The specific aims are:  

• 
Aim 1: Assess feasibility in six domains.52,53  
o a) Acceptability: Acceptability to patients and staff, assessed using qualitative 
and quantitative measures. 
o b) Process: Recruitment; refusal and retention rates; study 
completion; eligibility criteria; and number of sessions attended. 
o c) Practicality: The resources of the rehabilitation setting that support the 
BA intervention and the constraints that may interfere. These will determine 
the probability that BA can be implemented. 
o d) Treatment safety: Number of adverse events, those related and unrelated 
to the study. 
o e) Participant comprehension of interview questions and intervention activities. 
o f) Research burden: Length of interviews, participant fatigue, need for breaks, 
and emotional distress. 
 
• 
Aim 2: Provide preliminary evidence of response, assessed using a pilot 
randomized controlled trial (RCT). Evidence of response is also considered a 
feasibility focus. The pilot RCT will compare the BA group to a control group using a 
2-group design (see figure below). 
• 
Aim 3: Expand and refine the BA protocol and manual. The investigators, 
rehabilitation clinic staff, and two veterans with TBI will constitute a panel charged 
with adapting the preliminary manual for TBI for use in the pilot RCT and then 
monitoring the study on a monthly basis. They will evaluate the BA strategies and 
assess the interviews for burden and cultural sensitivity. This will lead to a refined 
BA protocol and manual, to be evaluated in a larger study of BA’s efficacy in the 
future. 
 
Exploratory Aim: We will examine engagement in activity as a possible mechanism 
that underlies BA effects on depression. 
 
2.2. 
State the hypotheses to be tested. 
This is not applicable in this feasibility study. 
 
3. 
Resources and Personnel 
3.1. 
Include where and by whom the research will be conducted.  
     The research will be conducted by the individuals listed in 3.2 at the CMCVAMC. 
 
3.2. 
Provide a brief description of each individual’s role in the study.  Be sure to 
indicate who will have access to protected health information and who will be 
involved in recruiting subjects; obtaining informed consent; administering 
survey/interview procedures; and performing data analysis. 
Helene Moriarty, PhD, RN, FAAN, Principal Investigator 
Access to PHI, involved in recruiting, consenting, administering survey/interview 
procedures at baseline, performing data analysis, providing input into the 
development of the intervention, participating in the development of 
presentations and papers arising from the work. 
Laraine Winter, PhD, Co-investigator and Project Manager,  
Access to PHI, involved in recruiting, consenting, administering survey/interview 
procedures, and performing data analysis, providing input into the development 

of the intervention, participating in the development of presentations and papers 
arising from the work. 
Keith Robinson, MD, Co-investigator  
Chief of the Rehabilitation Medical Service at CMCVAMC 
Access to PHI, involved in recruiting, administering survey/interview procedures, 
assessing the severity of TBI for all veteran study participants, providing input 
into the development of the intervention, and participating in the development of 
presentations and papers arising from the work. 
Tracey Vause-Earland, PhD, OTR/L, Co-investigator 
Access to PHI. She will provide training and oversight on behavioral activation for 
the OT interventionists and will be responsible for day-to-day oversight of 
delivery of the intervention arm. She will also monitor and ensure intervention 
fidelity through observation of some study sessions and review of audiotaped 
sessions. In addition, she will provide input into conceptual and methodological 
issues. throughout the conduct of the study, participate in regular team meetings, 
and will participate in dissemination of the findings. 
Two Occupational Therapy Interventionists (TBD) 
 Access to PHI, responsible for delivering the BA intervention.  
 
3.3. 
If applicable provide information on any services that will be performed by 
contractors including what is being contracted out and with whom. 
  Robin Casten, PhD 
No access to PHI. As a consultant on the study, Dr. Casten will share her 
expertise in behavioral activation throughout the study and oversee the training, 
with co-investigator Dr. Vause-Earland, for occupational therapists who deliver 
the BA intervention. Dr. Casten has worked closely with the team to develop the 
attached preliminary intervention manual (Appendix 1) for behavioral activation 
for persons with traumatic brain injury, and she will continue to provide input into 
the refinement of this manual. She will also collaborate with the study team to 
assess treatment fidelity throughout the study, will provide consultation around 
methodological issues, and will participate in data interpretation and papers. 
  
 
Two Consultants (TBD), to serve as Interviewers 
Access to PHI, involved in recruiting, consenting, administering survey/interview 
procedures. 
 
3.4. 
If applicable provide information on any Memoranda of Understandings (MOUs) or 
Data Use Agreements (DUAs) that are being entered into including with whom and 
for what reason. 
This study does not use an MOU or DUA. 
 
4. 
Study Procedures 
4.1. 
Study Design 
4.1.1. 
Describe experimental design of the study.  Include sequential and/or 
parallel phases of the study, including durations, and explain which 
interventions are standard of care.   
This feasibility study assesses feasibility in six domains and provides preliminary 
evidence of treatment response, through a pilot randomized controlled trial (RCT) 
The pilot RCT compares the intervention group (BA plus as Treatment as usual) 
with the control group (Treatment as usual). We will enroll 40 subjects (20 in each 

group), conduct a baseline interview, randomize into the two groups, and then 
conduct a follow-up interview 3 months later. Subsequently, a qualitative phone 
interview to assess the experience of the intervention along with 
satisfaction/acceptability will be conducted with those in the intervention group. 
The BA intervention will be delivered in 6 sessions over 3 months by OTs trained 
in BA for post-TBI depression. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Procedure. At the baseline interview, the interviewer will review the study, 
answer veterans’ questions, obtain Informed Consent, screen for depression 
using the CES-D scale and item 9 of the PHQ-9, and conduct the baseline 
interview battery. If the participant does not meet inclusion criteria based on 
the CES-D, and PHQ-9 at this time, they will not be included in the study as a 
randomized participant. We will thank them for their time, and they will receive 
compensation for the visit. They will also be offered referrals for services as 
appropriate.  
Response cards presenting each question’s response format will be employed 
to reduce response burden and facilitate interview progress. In previous 
studies, response cards were found helpful and acceptabl.47,48  The estimated 
time of the baseline interview is 1.3 hours, including time for Informed Consent. 
Interviews of this length have been conducted with veterans with TBI and 
depression in previous research and were not found excessively 
burdensome.47,48 The interview will be conducted in the setting preferred by the 
participant, a rehabilitation clinic office or his/her home. In our experience, most 
who complete the Baseline interview will be willing to continue to participate. 
Veterans who do not wish to continue with the study after the baseline 
interview will not be randomized or count towards our accrual goals. 
Within 48 hours of the baseline interview, eligible veterans will be randomized 
using the method of random permuted blocks (to control for possible changes 
over time in subject mix) and concealed allocation. Those randomized to BA 
will be contacted within 5 days by the interventionist and scheduled for the first 
session.  
 
Those randomized to BA will receive the 6-session BA intervention (as well as 
treatment as usual [TAU]). Control participants will receive TAU only (which 
may include current medical and mental health treatments.) Three months 
after Baseline, a blinded interviewer will conduct the follow-up interview in 

person or on the phone with all veterans. Subjects will be sent reminder letters 
two weeks prior to this 3-month follow-up interview. 
 
Study instruments and when they are used are described in a table in Section 8 
and included in the Appendices. 
 
Study staff will offer to share findings with participants. 
 
4.1.2. 
Include a description of how anticipated risk will be minimized and include 
an analysis of risk vs. potential benefit. 
This study is designed for persons with TBI who have a CES-D score of 16 or 
greater at both screening and baseline. Such a score indicates the presence of 
clinically significant depressive symptoms. Those who answer affirmatively (1, 2, 
or 3) at the baseline interview to item 9 from the PHQ-9, indicating suicide 
ideation, will not be eligible for the study.  
 
Because this study involves interviews with persons with TBI who have at least 
mild depression, there is a minimal risk that the interviews may contribute to 
emotional discomfort in the discussion of personal matters. In our previous study 
of veterans with TBI in their homes (the large majority of whom scored above the 
cutoff for clinical depression on the CES-D Short Form), using many of the same 
interview instruments as proposed, we encountered no upset or excessive fatigue 
with any participants nor did any adverse events occur as a result of study 
participation. 
  
The study poses minimal risk to study participants, based on experience with our 
earlier in-home intervention study with veterans with TBI, the literature on 
rehabilitation interventions with persons with TBI, and literature on BA. The risk of 
burden or fatigue from the interview or intervention is also low.  
 
Risks to privacy or subject discomfort about disclosing or considering sensitive 
information  
Study procedures are thoroughly explained during the consent process.  
Participants are assured that they can withdraw at any time or refuse to 
participate or respond to interviews or specific interview questions.  When 
interviewing respondents, interview procedures will be employed to avoid 
overtaxing or burdening respondents and to enhance communication.   
 
To minimize the potential risk of breach of confidentiality, the following safeguards 
will be in place: 
 
• 
Study data from all sources (survey, interviews, and electronic record) are de-
identified and only code numbers used. The master list linking code numbers 
with participant names and contact information is maintained separately from 
the de-identified data on a secure server.   
• 
Study databases do not contain any identifiable data. All VA regulations for 
data security and encryption will be followed as required.   
• 
If an interventionist or interviewer makes any visits to homes, they will 
transport identifiable data (e.g., name and address) in a locked briefcase. 

Interventionists and interviewers receive initial and ongoing training to follow 
the mechanisms in place to ensure confidentiality of data.   
• 
All study data are stored in a secure server.   
• 
Study results will be represented only by aggregate data.   
• 
All questionnaires and transcriptions of interviews are kept in a locked file 
cabinet (separate from the master list with participant names and assigned 
numbers. A master list of study participants that includes the assigned ID #, 
the first and last names, and any project-necessary grouping designations 
maintained for tracking purposes on PC computers is password protected on 
a secure server and stored in locked filing cabinets.  Screening forms and 
data collection cover sheets that include identifying information are necessary.  
All such information is considered confidential and stored in a locked file 
cabinet separate from study data.   
• 
All consent forms are kept in a locked file cabinet (separate from the master 
list with participant names and assigned numbers).  
 
• 
Data collection takes place in a private place in the rehabilitation setting or by 
phone when the participant is in a private place.     
Telephone conversations with or about study participants require common sense 
discretion.  Attempts to schedule data collection with study participants or telephone 
conversations discussing issues related to the participants are conducted in a 
manner that assures confidentiality.  When talking on the telephone, office doors 
are kept closed, voices are kept low, and last names are not used beyond what is 
necessary. Computer files used for the purpose of tracking study participants are 
set up with password protection. Access to these files is restricted to defined key 
personnel approved by the VA IRB.  
Interviewer Training, conducted by the Drs. Moriarty and Winter, will emphasize 
consent as an ongoing process and dialogue and will provide the interviewer with 
detailed study information to ensure that the interviewer understands the protocol 
and can answer questions about the study.  All research staff will undergo initial 
training by Drs. Moriarty and Winter to review confidentiality procedures consistent 
with the protocol and IRB regulations; they will monitor adherence to the 
confidentiality safeguards on a weekly basis.   
 
 
 
Risks of fatigue or research burden 
During the baseline and follow up interviews, the interviewer is alert for signs of 
fatigue or upset with the data collection procedures. The data collection can be 
stopped and continued at another time if the participant becomes fatigued. The 
interviewer will offer breaks at least two times during the interview. If the participant 
appears upset, the interviewer will stop the data collection process and offer 
support as needed. Data collection can be continued at another time if the 
participant desires.  
Response cards presenting each question’s response format will be employed to 
reduce response burden and facilitate interview progress. Used in our previous 
studies, response cards were found helpful and acceptable to participants. The 
estimated time of the baseline interview is approximately 1.3 hours, plus time for 
Informed Consent. Interviews of this length have been conducted with individuals 
with TBI and depression in our previous research and were not found excessively 

burdensome. The interview will be conducted in the rehabilitation clinic office or 
home setting if preferred by the participant. Follow-up interviews will be conducted 
in-person or by phone.   
Potential Benefits of Research to Subjects and Others:  
The proposed study may provide benefits to study participants. Participants may 
acquire skills to help reduce their depressive symptoms and increase their 
participation in activities and the community. Participation may lead to more 
veterans with TBI being assessed and identified as having mild or moderate 
depressive symptoms. It is also possible that participants may have no direct 
benefit.  
 
The present application of BA to TBI-related depression is designed to augment 
current clinical care for TBI. It does not take the place of other treatments for 
depression that persons with TBI may be receiving.  Study participants are not 
asked to stop other treatments they are receiving for TBI or mental health 
problems.  Results from the study will allow us to assess the feasibility of BA for 
veterans with post-TBI depression and will provide preliminary data to support a 
future larger efficacy trial. This feasibility study and future research may generate 
new knowledge around the development and evaluation of interventions that 
reduce depression and improve community reintegration for veterans with TBI.  
 
Risk vs. Benefits  
Knowledge gained through this feasibility study and future larger studies has the 
potential to advance the care of persons with depression post TBI and to extend 
our knowledge on the feasibility and efficacy of interventions for this population.  
Given that TBI is a major public health problem for military and civilian populations 
and in light of the high prevalence of depression post-TBI, the potential benefits 
for this population and society outweigh the potential risks 
 
4.1.3. 
Provide description of the study population (delineate all categories of 
subjects – patients, providers, family members, employees, etc.). Include 
anticipated enrollment numbers. 
A total of at least forty male and female Veterans at a VA outpatient 
Rehabilitation Medicine Service will be recruited to participate. We will 
oversample women to assure approximately 10% in each arm.  
 
4.1.4. 
As applicable, provide information on any added protections for vulnerable 
populations.  
N/A 
 
4.1.5. 
If applicable include information on data and specimen banking. 
N/A 
 
5. 
Recruitment Methods 
5.1. 
State how many subjects will be needed.  
At least, forty male and female veterans at a VA outpatient Rehabilitation Medicine 
service will be recruited to participate.  
 

5.2. 
Describe when, where, how and by whom potential subjects will be identified and 
recruited.  
Names of veterans meeting inclusion criteria for age, diagnosis of TBI, and severity of 
TBI will be given by the Polytrauma Team, and then we will mail these Veterans l a letter 
of invitation that introduces the study and invites them to call the study phone number to 
express interest in the study. The letter also informs them that a member of the research 
team will be calling them to discuss the study. When a veteran expresses interest in 
continuing the discussion about the study, the team members will provide more 
information, answer questions, and determine eligibility. Once an individual is deemed 
likely eligible, the research interviewer will schedule the baseline interview.  
A study flyer with a study phone number will be posted at the CMCVAMC, and Veterans 
may contact us from that. 
 
5.3. 
Describe materials that will be used to recruit subjects, e.g., advertisements.  
Include materials as an appendix or separate attachment 
Informational flyer (Appendix 4); Letter of Invitation (Appendix 5); Telephone script used 
after letter (Appendix 2) 
 
5.4. 
Describe any payments to subjects, including the amount, timing (at the end of the 
study or pro-rated for partial study participation), method (e.g., cash, check, gift 
card), and whether subjects will experience a delay in receiving the payment. 
There will be incremental payment for interviews: $40 for completion of the Baseline (BL) 
interview and $50 for the follow-up interview at 3 months.  
 
6. 
Informed Consent Procedures 
6.1. 
Indicate if informed consent will be obtained and/or if you are requesting a waiver 
of informed consent or waiver of documentation of informed consent.  If the 
research involves multiple phases, specify for which phases of the research the 
waiver(s) is being requested and/or the informed consent will be sought. 
We will obtain informed consent at the Baseline (BL) visit. We will obtain a Waiver of 
HIPAA for prescreening (letters, post-letter phone call.) 
 
6.2. 
Describe who will be obtaining informed consent, if applicable, and any 
circumstances that may need to be addressed (e.g. subjects with impaired 
decision making ability and the use of a legally authorized representative, etc.) 
The interviewers will obtain informed consent at the BL visit. This will take place at the 
CMCVAMC or at the subject’s home, whichever the subject prefers. Subjects with 
impaired decision making ability or requiring a legally authorized representative will not 
be included. 
 
6.3. 
If applicable, indicate how local site study personnel will be trained regarding 
human subjects' protections requirements and how to obtain and document 
informed consent. 
To ensure subject safety and the validity and integrity of the data, Drs. Moriarty and 
Winter will be responsible for training the Research Interviewer(s) in enrollment and the 
ongoing consent process.   
 
Interviewers will receive a set of readings on TBI and background on the study. They will 
undergo a one-day training on depression, TBI, the interview batteries, human subjects 

protections, and safety plans. They will conduct four practice sessions with staff and role 
play as participants in four practice interviews. 
 
Dr. Moriarty or Winter will observe several early interviews for each interviewer to assure 
integrity in the consent process and data collection process and adherence to 
confidentiality safeguards. They will provide additional training and review on a regular 
basis.   
 
7. 
Inclusion/Exclusion Criteria 
7.1. 
Describe the criteria that determine who will be included in or excluded from the 
study.  
Inclusion Criteria. Veterans must be >21 years of age, meet professional criteria for 
mild or moderate TBI 54 and have a CES-D score > 16 at both the Telephone Screen 
and Baseline.56,57 Inclusion of those with mild TBI (mTBI), representing up to 50% of 
post-TBI depression, will provide a representative sample7,12. This also addresses the 
need for interventions that can prevent escalation from minor to major depression.48,49 
Those taking antidepressants or other medications affecting mood or behavior must 
have been using these for at least three months, to allow for stabilization. Similarly, 
those in psychotherapy can participate if therapy has been ongoing for three months or 
longer. Veterans must acknowledge current TBI-related symptoms on the Telephone 
Screen (Appendix 2) and speak English. Inclusion of those with other physical 
symptoms (e.g., pain) or who meet criteria for PTSD will insure a more representative 
TBI sample. 
 
Exclusion criteria are a diagnosis of severe TBI; psychosis; aphasia; history of bipolar 
disorder, history of severe physical aggressiveness, judged by the clinical team; or 
currently receiving CBT for depression. Veterans with severe TBI were judged 
unlikely to be able to fully engage in BA. Dementia will be an exclusion. Since no 
cutoff on standard dementia-screens is established for TBI populations, probable 
dementia will be determined on a case-by-case basis using physician diagnosis and 
difficulty understanding interview questions. A review of CPRS will confirm TBI 
diagnosis and severity. 
 
8. 
Study Evaluations 
8.1. 
Describe all evaluations to be conducted (including screening; 
tests/questionnaires that will be administered; any procedures that subjects will be 
required to complete) and data collection methods.  Include materials as an 
appendix or separate attachment. 
The table describes the constructs, the instruments that operationalize them, number of 
items, and when administered. Appendix 6 presents the baseline and 3 month follow-up 
interview batteries. 
Table 2. Study constructs, measures, number of items, and when administered. 
CONSTRUCTS 
MEASURES 
 
 
OSU TBI 
Short form 
Ohio State University TBI Identification Method-Short form55 to confirm TBI diagnosis (OSU TBI-ID-
SF) Baseline interview 

Depressive 
Symptoms 
The Center for Epidemiologic Studies Depression Scale (CES-D) is a well-established 20-item 
screening instrument that shows good psychometric properties in TBI populations. 56,57,58  Baseline 
& Follow-up interviews. 
PHQ, 
question 9 
The Suicide Ideation (Patient Health Questionnaire [PHQ-9], item #9)59 Baseline & Follow-up 
interviews.  
Positive & 
negative 
affect 
The 20-item Positive and Negative Affect Schedule60 (PANAS) is used to capture a wide range of 
emotions, allowing a broader examination of possible intervention effects beyond depressed affect. 
Baseline & Follow-up interviews.    
Community 
Reintegration 
The 17-item Participation Assessment with Recombined Tools-Objective (PART-O-17) 61, 62 is an 
objective measure of social functioning, developed from 3 existing CR measures to examine long-term 
outcomes and to evaluate intervention efficacy.78, 79 Baseline & Follow-up interviews. 
Quality of 
Life in TBI 
The QoL-TBI 63, 64, 65, 66 is a 37-item patient-centered measure that captures the individual’s perception 
of his/her health-related quality-of-life (HRQoL) in cognition, self-care, daily life and autonomy, social 
relationships, emotions, and physical problems. Baseline & Follow-up interviews. 
Demographics 
& military 
characteristics 
These characteristics are age, sex, years of education, race, Hispanic ethnicity, marital status, 
employment status, financial difficulty, combat exposure, and war cohort. Baseline interview. 
Relevant 
health data 
Years since most recent TBI, severity of TBI, co-morbidities, source of injury (e.g., blast exposure, 
vehicular, fall), number of TBIs, and history of prior TBIs and of depression. Baseline interview 
and CPRS review.  
Post- 
Traumatic 
Stress 
Disorder 
The 20-item PCL-567, 68 is a self-report measure of PTSD symptom severity assessing 20 symptoms 
experienced in the past month that correspond to the DSM-V. Each item is rated on a 5-point Likert 
scale, from 1 (not at all bothered) to 5 (extremely bothered). A score between 31-33 indicates 
probable PTSD.86 Baseline interview. 
Patient self- 
ratings of 
functioning 
Self-rated competency in daily activities is measured using the Patient Competency Rating Scale 
(PCRS),69,70 a 30-item standardized measure of patient competency designed for TBI populations. 
The stem question is, “How much of a problem have you had (in the past month) in …?” The 
response format is a five-point Likert scale from 1 (cannot do) to 5 (can do with ease). Higher scores 
indicate better functioning. Baseline and Follow-up interviews. 
Healthcare 
services 
utilization 
Veterans with TBI may use outpatient and inpatient care, mental health services, social services, and 
military service-connected and/or disability services. This Checklist will assess frequency of use of 11 
healthcare services in the past month and since the baseline. Baseline and Follow-up interviews. 
Behavioral 
Activation 
The 23-item Behavioral Activation for Depression Scale (BADS)71 measures engagement in social 
and occupational activities hypothesized to underlie depression and targeted for change by BA, using 
7-point Likert responses from 0 (not at all) to 6 (completely). Baseline and Follow-up interviews. 
Pain and self-
rated health 
Pain (frequency and intensity) and self-perceived health are especially germane to TBI and depression. 
These measures are taken from the SF36,72 a well-established measure of health-related quality of life. 
Baseline interview. 
COVID Impact CAIR Pandemic Impact Questionnaire measures the physical, psychological, and financial impact of the 
COVID-19 pandemic73 Baseline and Follow-up interviews 
Dose and 
Intensity  
The Delivery Assessment form (Appendix 7) is completed by the OT- interventionist after each session, 
documenting start and stop times, treatment setting, TBI-related problems worked on, BA components 
used, and amount of time for each. These data will be used to characterize the intervention content.  
Each OT-intervention session.   
OT-rated 
Acceptability  
This 18-item Acceptability and Enactment Scale is part of the Delivery Assessment Form (Appendix 7) 
based on measures extensively used by the investigators.39 Final OT session.   
Acceptability 
and experience 
of BA to 
participants   
Measures of acceptability and perceived benefits from BA are collected in a final phone interview,  
immediately after the 3-month follow-up interview, with BA participants Appendix 9). Acceptability by 
patients – final phone interview.   
Acceptability to 
clinic staff 
Questions elicit clinic staff’s thoughts about the feasibility and acceptability of a BA-based intervention in 
the rehabilitation clinic setting. Acceptability by staff – after completion of data collection. 
 
 

9. 
Data Analysis 
9.1. 
Provide sample size determination and analysis (include anticipated rate of screen 
failures, study discontinuations, lost to follow-up etc.). 
This is a feasibility study using 40 subjects. It will assess recruitment, refusal, and 
retention rates and other indicators of feasibility as described earlier. 
 
9.2. 
Describe how, where and by whom the data will be analyzed. 
Data will be analyzed at the CMCVAMC by the PI and Co-Is. 
Aim 1 will assess the feasibility of BA in the VA rehabilitation setting,  following  criteria 
suggested by Bowen et al.52  and Thabane et al.53:: 
Acceptability to veterans and staff, assessed using qualitative and quantitative 
measures. Qualitative: This analysis will be conducted for open-ended interview 
questions concerning the experience of receiving BA (for veterans) and the process 
of its implementation in the rehabilitation setting (for clinic staff). After verification of 
transcript accuracy for interviews, ATLAS.ti will be used to facilitate data 
organization, coding, and retrieval. Qualitative content analysis74 will inductively 
generate codes and categories. Line by line coding will be conducted to identify 
codes or statements of meaning (level I coding) that are then grouped into larger 
categories (level II, coding for themes). Strategies to support scientific rigor will be 
followed: for credibility (member checking findings with a subsample of participants); 
dependability (audit trial); transferability (thick description); and confirmability (audit 
trial).75 
Quantitative: (1) On the Acceptance/Receipt Scale completed by the interventionist 
(final Delivery Assessment form), at least 75% should score > 3.0 (Appendix 7); (2) 
On the Satisfaction Scale, administered to BA participants during the final interview 
(Appendix 9), > 75% should score > 3.0. (3) Willingness to participate in future 
related studies should be > 75%. Criteria are based on our past study.47 
(a) Process: (1) For recruitment, >50%, percent of veterans will be eligible to 
participate, and >30% will be willing to participate. (2) For retention, >75% of 
veterans in BA will attend > 4 sessions, and >75% will complete the study. (3) Less 
than 15% deviation from protocol on the Treatment Fidelity Checklist will occur. 
(b) Practicality: Resources of the rehabilitation setting that support the BA intervention 
and constraints that may interfere will assess the probability that BA can be 
implemented. Resources and constraints will be assessed by interventionists, the 
project manager, and clinic staff through discussions on issues including 
scheduling, coordination with other appointments, staff time, and space providing 
privacy. 
(c) Treatment safety: Number of adverse events (study-related and unrelated) will be 
monitored. 
(d) Eligibility criteria: The team will assess whether these criteria were too broad or 
restrictive. 
(e) Participant comprehension: Interviewer and interventionist will note areas 
of participant difficulty understanding interview questions and intervention 
activities. Missing data will also reflect difficulty. 
(f)  Research burden: Length of time to complete interviews will be recorded using 
start and stop time data on the interview. The interviewer will record participant 
fatigue, wish to take breaks, and/or emotional distress. 
 
Aim 2 will assess change in participant response by comparing Group 1 (BA + TAU) 
and Group 2 (TAU) on outcomes at T2 (3-month follow-up). We will first conduct 

descriptive analyses separately for the BA and control groups to characterize the 
sample and assess the success of randomization in balancing the two groups. We will 
inspect trends, directions of change in the two groups, and associations between 
baseline characteristics (T1) and CES-D scores at follow-up (T2). The same trends 
and changes will be inspected for the secondary outcomes of CR and QOL. Analyses 
will be conducted using SPSS version 25. 
Aim 3 is to develop and refine the BA protocol, manual, and interview measures. In 
the first 3 months, an expert panel comprising the investigators, interventionists, 
interviewer, clinic staff, and two veterans with TBI will review and modify the existing 
protocol and manual to adapt them for hallmark deficits of TBI. The panel will meet 
monthly to monitor the study, assessing need for additional compensatory strategies 
and removal or alteration of strategies that depend on: abstract thinking; patients’ 
understanding of TBI-related depression; awareness of emotion and its regulation; 
and interpersonal issues. Interview measures will be assessed for participant 
comprehension, sensitivity, and burden. This pilot study will produce a refined BA 
protocol and manual for post-TBI depression whose efficacy will be evaluated in a 
larger RCT. 
An Exploratory Aim will examine engagement in activity as the mechanism underlying 
effects of BA. Although mediation analysis is beyond the scope of this feasibility study, 
we will explore characteristics of activity engagement using the BADS and its 
associations with the BA intervention and with depression. 
 
 
10. 
Withdrawal of Subjects 
10.1. Describe any anticipated circumstances under which subjects will be withdrawn 
from the research without their consent.  
Subjects may be withdrawn from the study by the PI without their consent if the PI deems 
it in the best interest or safety of the subject, such as if the subject expresses suicidal 
ideation, or increased depression that would increase risk of suicide. The study PI or 
project manager will notify the subject directly and offer a safety visit (in person or over 
the phone) and referrals for other services. Subjects will not be withdrawn for changes in 
antidepressants or other medications affecting mood or behavior, or for changes in 
psychotherapy after consenting. Investigators will document the change(s).  
 
10.2. Describe the consequences of a subject's decision to withdraw from the research 
and the procedures for orderly termination of participation by the subject (e.g., the 
subject contacting the investigator for an end-of-study visit). 
The subject may withdraw at any time. Subjects will be offered a safety visit and referrals 
for other services to provide more support after an early withdrawal (by subject or 
investigator). 
 
11. 
Reporting 
11.1. Include procedures for reporting unanticipated problems, serious adverse events, 
and protocol deviations. 
Adverse events, protocol deviations, and unanticipated problems will be collected at each 
study visit or intervention following the signing of the informed consent, or when the study 
team becomes aware of them. They will be reported to the IRB at the time of continuing 
review, or sooner, per IRB requirements, as necessitated by the type of event (e.g. SAE, 
serious unanticipated problem, protocol deviation impacting subject safety). 

  
 
Data and Safety Monitoring Plan   
Drs. Moriarty and Winter will be responsible for ensuring that the trial is conducted 
according to the protocol and will also be responsible for implementing the data safety 
and monitoring plan as described below. A data and safety monitoring plan is 
established to ensure the safety of all study participants and to ensure the validity and 
integrity of the data.   
 
To maintain the validity and integrity of the data, Drs. Moriarty and Winter will be 
responsible for training the Research Interviewer(s) in enrollment, the ongoing consent 
process, and data collection procedures and also be responsible for training the OT 
interventionists in their treatment-documentation procedures. Interviewer training will 
include a review of the eligibility criteria, study procedures, safety plans, completion and 
scoring of each of the study instruments, and safeguards to maintain confidentiality. Dr. 
Moriarty or Winter will observe the several early interviews for each interviewer to assure 
integrity in the consent process and data collection process and adherence to 
confidentiality safeguards. They will provide additional training and review as on a 
regular basis. They will also conduct a weekly inspection of IRB documents, study 
records, data security, and confidentiality safeguards to ensure that the study is adhering 
to the study protocol and research regulations.  These items will be part of the weekly 
discussions among the research interviewer, Dr. Moriarty, and Dr. Winter that will 
address fidelity to the data collection protocol.  
 
The training for the OT interventionists will include a review of the study protocol, 
confidentiality safeguards, and the safety plan for study participants who may need 
additional medical or mental health services. The interventionists will meet with the Drs. 
Moriarty, Winter and Vause-Earland twice monthly for debriefings. The co-investigator, 
Dr. Vause-Earland, will also observe at least five randomly selected intervention visits in 
Months 1-2 to monitor fidelity to the study protocol and confidentiality safeguards.     
 
Treatment Fidelity Monitoring 
We will monitor delivery of the intervention using a plan for providing oversight of 
treatment implementation based on the NIH Behavioral Change Consortium’s 
recommendations for assessing and maintaining treatment fidelity.76,77 The plan involves 
standardizing delivery and checking for protocol adherence utilizing three general 
strategies: following a treatment manual, checking adherence to the protocol, and 
maintaining provider skills. Specific steps to achieve treatment fidelity goals include the 
following:  
 
(a) The Behavioral Activation condition is manualized to insure standardization of 
delivery. 
(b) Twenty-five percent of the intervention sessions will be audiotaped by the 
interventionists (provided that the participant agrees to the taping), and the taped 
sessions will be reviewed by Drs. Moriarty and Winter and evaluated according to a 
priori criteria provided in a Treatment Fidelity Checklist (see Appendix 10).  
(c) Non-specific treatment effects (e.g., interventionist characteristics) will also be 
measured using the Treatment Fidelity Checklist by rating audiotaped intervention 
sessions.  
(d) To maintain interventionist skills and minimize drift, twice-monthly case conferences 
will be held. These will be attended by both interventionists and the investigators.  
 
Adverse Event (AE) Reporting 

Interventionists will be trained in procedures to manage distress, suicidal ideation, severe 
depression, and other responses as described earlier and noted in the table below.  
Given that both data collection and interventions may occur in people’s homes (if 
preferred by the study participant), there is the potential for a member of our research 
team to encounter a potential emergency situation that is not related to study participation 
(e.g., environmental risk, medical emergency).  We refer to such events as alerts and 
have well developed procedures for their management.  All alerts will be reported to the 
VA IRB as required.  We will follow the reporting requirements of the VA IRB. Thus, per 
the requirement of the VA IRB, all adverse events that are described in the informed 
consent will be reported to the IRB at continuing review and unexpected adverse events 
that are considered unrelated to the study will be reported at continuing review.  An 
unexpected adverse event that is related to the study will be reported to the VA IRB 
within 72 hours (business days) of the investigator’s becoming aware of it.  Serious 
adverse events will be reported to the VA IRB within 72 hours regardless of whether it is 
related to the study or whether it is an onsite or offsite event.  The event will be 
considered a serious adverse event, whether or not it is related to the study if any of the 
following six criteria are met:  1) hospitalization, 2) life-threatening reactions (e.g., heart 
attack), 3) persistent or significant disability/incapacity or permanent hardship or 
disability, 4) events that jeopardize the subject and require medical or surgical 
intervention to prevent one of the outcomes previously listed, 5) congenital anomaly/birth 
defect in the offspring of the research participant, and 6) death. Any deviations from the 
approved protocol will be reported to the IRB. A summary of all adverse events and/or 
unanticipated problems will be included with the continuing review/progress report for the 
IRB.   
 
Overview of Alerts, Adverse Events, and their Monitoring 
The table below describes the specific events we consider as an Alert or Adverse Event 
and the procedures we plan to follow.  
 
Table:  Other Specific Alerts/Adverse Events and Actions Taken   
 
Emergency Alert/Adverse E
 Event 
Action Taken 
Medical emergency: 
 -Chest pains 
- Excessive bleeding 
- Fall and cannot get up 
- Difficulty breathing 
If a research staff person encounters this situation while speaking on 
the phone, the person is put on hold and the staff person calls 911 
immediately. If the situation occurs within the home, the staff person 
calls 911 immediately and stays with participant until help arrives. If 
the situation occurs in the rehabilitation setting, procedures for 
medical emergencies will be followed. Dr. Moriarty and Winter are 
informed immediately of the event, and they contact the individual for 
a follow-up within two days.   
 
Research staff member completes alert form and reports adverse 
event to IRB as required.       
Threats to hurt self or 
others; severe depression; 
suicidality  
Described later in text (Safety plans).  
Evidence of abuse  
Evidence of physical abuse is as follows: 
• 
Participant states to research staff that abuse occurs 

• 
Research staff observes physical evidence (black eye, 
black and blue marks on arms/legs) 
 
If the interviewer or OTs suspects child abuse, they will report this 
immediately to Dr. Moriarty or Winter, who will discuss this with the 
Polytrauma Social Worker Case Manager. If there is reasonable 
cause to suspect child abuse, this will be reported to the Child Abuse 
Hotline with Child Protective Services (215-683-6100). If the 
interviewer or OTs suspect spouse or partner abuse, they will report 
this immediately to Dr. Moriarty or Winter, who will review the 
situation with the Polytrauma Social Worker Case Manager. 
Information and contact information for community resources (such 
as Philadelphia Domestic Violence Hotline and Women Against 
Abuse) will be shared with the family member who is being abused.  
If the interviewer or OTs suspect elder abuse, this will be reported to 
the appropriate agency. 
 
The PI reports adverse event to the IRB as required.    
Note – The mandated reporting of child and elder abuse is stated in 
the consent form.  
Extreme Home Hazards 
(if observed during  
home visit).  
 
-Exposed electrical wires 
-External door missing or 
cannot be locked 
-Ceiling, floors caved in 
-No temperature control (no 
air or heat – must be 
extreme) 
-Major infestation 
Research staff member notifies PI within 24 hours.  If alert is identified 
prior to baseline/randomization, the individual is not enrolled in study 
until the home hazard is addressed.  If enrolled in the study, the PI 
contacts participant and refers him/her to a home repair program.  
 
PI completes Alert form. 
 
Alerts and adverse events are reviewed at weekly meetings to assure that each has been 
managed appropriately and follow-up and resolution obtained. We expect adverse events to be 
infrequent. In the rare case in which multiple adverse events occur, the study team will meet to 
review the severity and cause and determine next study steps with the guidance of the IRB 
 
 
Safety Plan  
Given the population of interest (persons with TBI and depression), the team has developed a 
detailed safety plan for participants. The Rehabilitation Medicine Service and medical center 
employs mental health providers who can provide support to the study team for clinically 
emergent situations or circumstances that arise in the conduct of the research. A licensed 
clinician is always available at the medical center during business hours to facilitate assessment 
and support for emergent clinical situations. A licensed clinician is also available through the 
Behavioral Health Emergency Service during business hours and outside business hours.  
If the interviewer or interventionists observe that a study participant is a threat to self or others or 
has severe depression, a safety plan is in place to manage this situation. If a research staff 
person encounters a situation in the rehabilitation clinic in which the person is severely depressed 
and threatens to hurt self or others immediately, or has answered affirmatively to item 9 on the 

PHQ, the research staff member stays with the individual and calls on the emergency behavioral 
health services at the medical center. Patient can be escorted to the BH urgent walk-in clinic on 
the 7th  floor for immediate assessment. Patients can also be escorted to the emergency room 
where there is psychiatric staffing 24/7 for immediate assessment. If there is an established BH 
provider, a phone call will be made to try to make immediate contact. If the person is not an 
immediate threat to self or others, then the person is actively encouraged to contact his provider 
and/or the contact is made for the person if he/she chooses. The research staff also informs the 
person that a member of the research team will be contacting him/her shortly to follow-up. 
Immediately at the conclusion of the interview, Drs. Moriarty and Winter are notified of the 
situation. They contact the person to obtain further information and encourage immediate action. 
The team has compiled a list of community resources (VA and non-VA) that will be shared with 
subjects for appropriate mental health resources, crisis lines, financial resources, and other 
resources as needed.   
In the event that the interviewer or OT is meeting with the veteran in the home and assesses the 
veteran to be at high risk for suicide, or the veteran has answered affirmatively to the PHQ item 9 
at baseline, or is very distressed, they will refer the veteran to the appropriate mental health 
resources and provide information on how to access these resources. During business hours, 
veterans can call the Mental Health Clinic staff at 215-823-4300 or come as a walk-in to the clinic 
for problems that need immediate attention. After business hours, veterans can phone the 
Corporal Michael J. Crescenz VA Medical Center psychiatrist on call for problems that need 
immediate attention; the veteran would call the main hospital number at 215-823-5800 and ask for 
the psychiatrist on call.  If veterans are experiencing suicidal ideation, they can contact the 
Veterans Crisis Hotline at 1-800-273-TALK, call 911, or go to the nearest emergency room or the 
VA Medical Center’s emergency room.  When a veteran calls the 1-800-273-TALK crisis hotline 
number, he reaches the national hotline, indicates if he/she is a veteran by pressing 1, and then 
the hotline contacts the VA Medical Center Suicide Prevention Team, which contacts the 
veteran’s provider or arranges for a provider if the veteran does not have one. If veterans are 
experiencing homicidal thinking, they can call 911 or go to VA’s emergency room or the nearest 
emergency room. The interviewer or OT will encourage the veteran to seek the appropriate 
services, but if the OT or interviewer judges that the veteran needs emergency services for a life-
threatening medical or psychiatric emergency and is unable to contact these services, the OT or 
interviewer will call 911 for the veteran if in the home. The OTs and interviewer will also report 
psychiatric concerns to the Drs. Moriarty or Winter, who will consult, as needed, with Dr. Casten, 
a consultant, and Dr. Robinson, a co-investigator, Chief of the Medical Rehabilitation Service, who 
has expertise in VA resources available for veterans with TBI and mental health problems. As per 
VA IRB regulations, the PI will complete Adverse Event Reporting forms and report to the IRB, as 
required.   
 
Training for the Safety Plan   
Training of our interviewer and interventionists in the safety plan will be reinforced on a regular 
basis. The OT co-investigator responsible for training the OTs in BA and overseeing their work, as 
well as Dr. Robin Casten, consultant on this project, have experience in delivering BA and safety 
plans for participants with depression and mental health crises. Dr. Casten has conducted several 
studies using BA to reduce depression and increase activity.  Furthermore, Dr. Moriarty and Dr. 
Winter will provide education to the interviewer and OT interventionists on assessment of 
depression, signs of both suicide risk and warning signs of imminent suicide risk, how to respond 
and show support for participants at high risk for suicide, and how to connect veterans with 
suicide risk to appropriate resources/referrals. They will also provide training, along with Dr. 
Casten, on the Columbia Suicide Severity Rating Scale.78 The Columbia Scale will be 
administered to participants who answer affirmatively (1, 2, or 3) to item 9 on the PHQ-9, 

indicating the presence and duration of suicidal ideation. The Columbia Scale is an assessment 
tool that evaluates suicidal ideation and behavior; it has been used with military and civilian 
populations.  Outcomes on this scale that can be used for safety monitoring include scores on 
suicidal behavior lethality, suicidal ideation, and suicidal ideation intensity. It is evidence-based in 
that much research has validated its relevance and the effectiveness of its questions in assessing 
suicide risk. Triage guidelines are available for the tool that indicate risk and need for further 
evaluation and management (e.g., triggers for immediate referral to mental health services and 
patient safety precautions). Data from the PHQ item 9 and Columbia Scale will be shared when 
the person is referred for mental health services.  
The consent form will state that the research team may refer the participant to appropriate 
medical and mental health resources within the VA medical center. The consent will also note that 
in the event that a participant indicates an intention to harm self or others, we will be obligated to 
notify the appropriate medical and mental health professionals immediately. 
   
 
12. 
Privacy and Confidentiality 
12.1. Describe whether the study will use or disclose subjects’ Protected Health 
Information (PHI).  
The study uses subjects’ PHI but does not disclose it. 
 
12.2. Describe the steps that will be taken to secure the data (e.g., training, authorization 
of access, password protection, encryption, physical controls, Certificates of 
Confidentiality, and separation of identifiers and data) 
To minimize the potential risk of breach of confidentiality, the following safeguards will be 
in place: 
 
• 
Study data from all sources (survey, interviews, and electronic record) are de-
identified and only code numbers used.  The master list linking code numbers 
with participant names and contact information is maintained separately from 
the de-identified data on a secure server.   
• 
Study databases do not contain any identifiable data. All VA regulations for 
data security and encryption will be followed as required.   
• 
If an interventionist or interviewer makes any visits to homes, they will 
transport identifiable data (e.g., name and address) in a locked briefcase. 
Interventionists and interviewers receive initial and ongoing training to follow 
the mechanisms in place to ensure confidentiality of data.   
• 
All study data are stored in a secure server.   
• 
Study results will be represented only by aggregate data.   
• 
All questionnaires and transcriptions of interviews are kept in a locked file 
cabinet (separate from the master list with participant names and assigned 
numbers. A master list of study participants that includes the assigned ID #, 
the first and last names, and any project-necessary grouping designations 
maintained for tracking purposes on PC computers is password protected on 
a secure server and stored in locked filing cabinets. Screening forms and data 
collection cover sheets that include identifying information are necessary. All 
such information is considered confidential and stored in a locked file cabinet 
separate from study data.   
• 
All consent forms are kept in a locked file cabinet (separate from the master 
list with participant names and assigned numbers).  
 

• 
Data collection takes place in a private place in the rehabilitation setting or by 
phone when the participant is in a private place.     
 
 
13. 
Communication Plan for Multi-Site Studies or Studies being done at Non-CMCVAMC 
Locations    
  N/A; skip to question 14 
13.1. Include plan for ensuring all required local site approvals are obtained and 
notifying the Director of any facility where the research in being conducted but the 
facility is not engaged. 
      
 
13.2. Include plan for keeping all engaged sites informed of changes to the protocol, 
informed consent, and HIPAA authorization. 
      
 
13.3. Include plan for informing local sites of any Serious Adverse Events, Unanticipated 
Problems, or interim results that may impact conduct of the study. 
      
 
13.4. Include plan for ensuring the study is conducted according to the IRB-approved 
protocol. 
      
 
13.5. Include 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). 
      
  
 
14. 
References (bibliography of cited literature)  Please see list of cited references at the very end 
of document.  Our reference system does not allow us to place the references under item 14. 
 
 
 
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2 Defense and Veterans Brain Injury Center. Traumatic Brain Injury (TBI) Awareness. [Cited May 7,  
2018]   Available from http//: www.Info@dvbic.org.  
3 Juengst SB, Kumar RG, Wagner, AK. A narrative literature review of depression following traumatic  
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4 Osborn AJ, Mathias JL, Fairweather-Schmidt AK, Anstey KJ. Traumatic brain injury and depression in   
a community-based sample: a cohort study across the adult life span. J Head Trauma Rehabil. 2017 
May 17.  doi: 10.1097/HTR.0000000000000311. [Epub ahead of print] 
5 Bombardier CH, Fann JR, Temkin NR, Esselman PC, Barber J, Dikmen SS. Rates of major 
depressive disorder and clinical outcomes following traumatic brain injury. JAMA. 2010;313(19): 
1938-1945. 
 

 
6 Greer N, Ackland P, Sayer N, Spoont M, Taylor B, Macdonald R, et al. Relationship of deployment-
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10 Daggett VS, Bakas T, Buelow J, Habermann B, Murray LL. Needs and concerns of male combat 
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