Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
Phase: NA
Conditions: Post-traumatic Stress Disorder, Traumatic Brain Injury, Substance Related Disorders, Depression, Anxiety Disorders, Suicide, Pain
Sponsor: VA Office of Research and Development

 
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Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop 
March 1st, 2023 
NCT03868930

 
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Study Title: Multisite RCT of STEP-Home: A transdiagnostic skill-based reintegration workshop 
IRB #: 3210 
PI: Catherine B. Fortier, Ph.D. 
Protocol Date: March 1st, 2023 
 
STUDY PROTOCOL 
 
1. Rationale 
 
(a) Statement of the Problem: Post-9/11 Veterans who served in OEF/OIF face many challenges as they re-
enter civilian life after structured military careers. Yet, underutilization and resistance to mental health 
treatment remains a significant problem [3-5]. Recent investigations of community reintegration problems 
among returning Veterans found that half of combat Veterans who use Veterans Administration (VA) services 
reported difficulty in readjusting to civilian life, including difficulty in social functioning, productivity in work and 
school settings, community involvement, and self-care domains [6, 7]. High rates of marital, family, and 
cohabitation discord were reported, with 75% reporting a family conflict in the last week [8]. At least one-third 
reported divorce, dangerous driving and risky behaviors, increased substance use, and impulsivity and anger 
control problems since deployment. Almost all Veterans expressed interest in receiving services to help 
readjust to civilian life, and receiving reintegration services at a VA facility was reported as the preferred way to 
receive help. Mental health and anger problems are often cited as driving Veterans’ difficulties readjusting to 
civilian life. Anger is becoming more widely recognized for its involvement in the psychological adjustment 
problems of post-9/11 Veterans [9]. Research has shown that anger directly influences treatment outcome [10]. 
In fact, history of untreated PTSD and aggression have been demonstrated to be pervasive among post-9/11 
Veterans who die by suicide in the months before death [11]. Veterans with probable PTSD report more 
reintegration and anger problems, and greater interest in services than Veterans without [6]. Reintegration and 
anger problems continue for years post-combat and may not resolve without intervention [7]. 
 
*In February 2023, we received approval for a 1-year cost extension to continue this study for one additional 
year; the study end date is now 3/31/24 instead of 3/31/23. Any relevant changes to the study protocol 
resulting from this timeline extension are outlined below, where appropriate. 
 
Phase 1: Years 1 and 2 
We will initiate the study at the Boston VAMC and develop Standard Operating Procedures for the addition of 
site 2 in Phase 2. 
 
Phase 2: Years 3, 4, and 5 
We will initiate the study at the second site, the Houston VAMC, in Year 3. We have obtained IRB approval to 
initiate site 2 from the Houston VA (see attached documentation of approval by Michael E. DeBakey Medical 
Center IRB). Given the transition to telehealth workshops, we now plan to initiate recruitment only for Veterans 
through site 2 (Houston) during Years 3, 4, and 5.  
 
In-person workshops may be initiated at site 2 (with appropriate IRB approvals) in the future. 
 
(b) Hypotheses & Aims 
 
Primary Aim 1. Examine treatment effects of STEP-Home on primary outcomes relative to Present 
Centered Group Therapy (PCGT):  
Hypothesis 1A. Participants randomized into the STEP-Home intervention will show improvement on 
reintegration, readjustment, and anger post-intervention (expressed by lower scores; less difficulty). 
Military to Civilian Questionnaire (M2CQ), Post-Deployment Readjustment Inventory (PDRI), and State-Trait 
Anger Expression Inventory (STAXI-2) scores post-intervention (T4) < baseline (T1) 
 
Hypothesis 1B. Participants randomized into STEP-Home will show greater improvement in primary 
outcomes as compared to PCGT.  
Change scores baseline (T1) to post-intervention (T4) STEP-Home > PCGT change scores 

 
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Post-intervention (T4) primary outcome scores STEP-Home < PCGT primary outcome scores (T4) 
 
Primary Aim 2. Examine maintenance of treatment effects on primary outcomes:  
Hypothesis 2: Treatment effects will be maintained at follow up in both groups.  
Differential treatment effect of STEP-Home over PCGT post-intervention (T4) will be maintained at follow up 
(T5) 
 
Exploratory Aim 1. Explore treatment effects of STEP-Home on measures of mental health, functional 
and vocational status and cognitive secondary outcomes targeted indirectly in the workshop. 
 
Exploratory Aim 2. Acquisition of core skills (problem solving, emotional regulation, attention training) 
will mediate the effect of treatment on primary outcomes post-intervention and at follow up. 
 
2. Background and Significance 
 
(a) Background: The unique and challenging needs of post-9/11 Veterans necessitate the development of 
novel, empirically validated, skill-based, integrative interventions for civilian reintegration that are cost-effective 
and can be easily implemented across the VA system. Returning Veterans face high rates of reintegration 
difficulties that continue for years post-deployment and may not resolve without intervention [6]. We have 
described this cohort as “multi-morbid” [36]. Attempting to care for such complicated patients with single 
modality treatments has had limited success [29-31, 37, 38] and integrated transdiagnostic treatments for this 
cohort are quite limited [39-41]. Those that do exist are designed for Veterans meeting multiple clinical 
diagnoses and may not be appropriate for the broad range of Veterans STEP-Home is designed to help. We 
are not aware of any skills-based program that seeks to help all Veterans (with or without clinical diagnoses) 
reintegrate into civilian life. Research on TBI in post-9/11 Veterans [42, 43] underscores the need for programs 
that utilize an interdisciplinary approach to reintegration. Programs designed to address challenges of Veterans 
as they reintegrate in vocational environments, particularly integrative approaches, are greatly needed [44]. 
The STEP-Home intervention provides such a program. STEP-Home includes focused cognitive and emotional 
regulation skills training and is informed by the most recent research with returning Veterans and available 
programs focused on reintegration in VA and military settings (e.g., Battlemind training [45]).  
 
(b) Significance: In this proposal, we extend our previous SPiRE feasibility and preliminary effectiveness 
study to examine STEP-Home efficacy in a RCT design. This novel therapy will target the specific needs of a 
broad range of underserved post-9/11 Veterans. It is designed to foster reintegration by facilitating meaningful 
improvement in the functional skills most central to community participation: emotional regulation (ER), 
problem solving (PS), and attention functioning (AT). The skills trained in the STEP-Home workshop are novel 
in their collective use and have not been systematically applied to a Veteran population prior to our SPiRE 
study. STEP-Home will equip Veterans with skills to improve daily function, reduce anger and irritability, and 
assist reintegration to civilian life through return to work, family, and community, while simultaneously providing 
psychoeducation to promote future engagement in VA care. 
 
The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an adaptation of an 
established and efficacious intervention [2, 46, 47] now applied to post-9/11 Veterans; (b) nonstigmatizing (not 
“therapy” but a “skills workshop” to boost acceptance, adherence and retention); (c) transdiagnostic (open to all 
post-9/11 Veterans with self-reported reintegration difficulties; Veterans often have multiple mental health 
diagnoses, but it is not required for enrollment); (d) integrative (focus on the whole person rather than specific 
and often stigmatizing mental and physical health conditions); (e) comprised of Veteran-specific content to 
teach participants cognitive behavioral skills needed for successful reintegration (which led to greater 
acceptability in feasibility study); (f) targets anger and irritability, particularly during interactions with civilians; 
(g) emphasizes psychoeducation (including other available treatment options for common mental health 
conditions); and (h) challenges beliefs/barriers to mental health care to increase openness to future treatment 
and greater mental health treatment utilization. Many Veterans who participated in the development phases of 
this workshop have gone on to trauma or other focused therapies, or taken on vocational 
(work/school/volunteer) roles after STEP-Home. 
 

 
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We have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill 
acquisition that we demonstrated to be directly associated with post-workshop improvement in reintegration 
status in our SPiRE study. Given the many comorbidities of this cohort, our innovative treatment addresses 
multiple aspects of mental health, cognitive, and emotional function simultaneously and bolsters  
reintegration in a short-term group to maximize cost-effectiveness while maintaining quality of care [48].  
 
(c) Relevance to Veterans Health: The successful completion of the aims proposed has the potential to 
significantly improve skills to foster civilian reintegration in post-9/11Veterans. Furthermore, the STEP-Home 
SPiRE feasibility study demonstrated that the workshop also serves as a gateway for Veterans who are 
hesitant to participate in traditional mental health treatments to promote openness and engagement in 
additional, critically needed, VA services. Given the high rate of treatment resistance in this cohort, developing 
acceptable interventions that promote treatment engagement and retention, and open the door to future VA 
care, is necessary to improve functional status and to reduce long-term healthcare costs of untreated mental 
health illnesses. 
 
3. Work Accomplished 
 
Data from our successful SPiRE feasibility and preliminary effectiveness study [10] has demonstrated: (1) 
STEP-Home was acceptable in this Veteran cohort; and (2) the change in treatment related skill acquisition 
was associated with improved community reintegration status (as measured by the Military to Civilian 
Questionnaire; M2CQ) post-workshop. Critically, the dropout rate for the STEP-Home workshop was less than 
half that observed in standard psychological treatment for PTSD in post-9/11 Veterans [11]. Data also 
demonstrated that STEP-Home functions as a gateway by increasing engagement in both vocational activities 
and critically needed mental health treatments at VA for Veterans hesitant to seek help. STEP-Home offers a 
much needed, palatable, and minimally stigmatizing intervention for post-9/11 Veterans struggling with 
reintegration difficulties that is feasible, acceptable, and has shown preliminary effectiveness. 
 
4. Work Proposed 
 
(a) Study Objectives: There are two major experimental objectives to this project: (1) To examine treatment 
effects of STEP-Home on primary outcomes relative to Present Centered Group Therapy (PCGT); (2) To 
examine maintenance of treatment effects on primary outcomes; and two exploratory aims: (1) To examine 
treatment effects on secondary outcomes targeted indirectly in the workshop; (2) To determine if acquisition of 
core skills or “key ingredients” mediates primary outcomes. In February 2023, we received approval for a 1-
year cost extension to continue this study for one additional year; the study end date is now 3/31/24 instead of 
3/31/23. Therefore, the objectives listed above will be accomplished across a 5-year timeline, instead of the 
original 4-year timeline. 
 
(b) Study Design (Phase 1): We will conduct a randomized control trial (RCT) of STEP-Home at the VA 
Boston Healthcare System, Jamaica Plain campus and the Michael E. DeBakey Medical Center in Houston. 
With the 1-year study extension approved in February 2023, our funded aims have been updated to enroll 144 
Veterans in Boston (original enrollment number was 112 in Boston) and 96 in Houston for a total of 240 
participants. In order to achieve this, given drop out, we will recruit 300 Veterans overall, when accounting for 
participants at both sites.  
 
Recruitment will be conducted in Boston (Years 1-5) and Houston (Years 3-5). Beginning in Year 3, Houston 
TRACTS/STEP-Home staff will assist in recruitment and referrals. The Houston site will assist with any clinical 
and/or safety concerns for Houston Veterans under the leadership of site PI, Ricardo Jorge, MD, a licensed 
psychiatrist with ample experience in this arena in coordination with Boston and study PI, Catherine Fortier. All 
study procedures across both sites will be reviewed by our Data Safety Monitoring Board and reported to local 
IRBs at both sites. 
 
Participants will be randomly assigned to receive one of the two group interventions: STEP-Home or PCGT, 
and each intervention will meet one time a week for 12 weeks. We will use statistical software to conduct 
cluster randomization to assign veterans to the intervention group. We do not plan to use matching or stratified 

 
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randomization to balance the interventions on patient characteristics (e.g. age, prevalence of traumatic brain 
injury and psychiatric conditions, etc.) since we do not have any a priori reason to expect that such factors will 
significantly influence our primary outcomes. We will assess any patient characteristics as possible 
confounders in our analyses if they differ across groups (see Analytic Plan below). Given the group treatment 
modality for both conditions, it will be necessary to accrue participants for a cohort before randomization and 
treatment can begin. Each cohort will include a minimum of 8 and a maximum of 20 participants who will be 
randomized to either STEP-Home (n=4-10 Veterans per treatment group) or PCGT (n=4-10 Veterans per 
active control). The treatment group and active control group will be matched in size (n’s equal at 
randomization) and populated based on recruitment success. The goal will be to recruit 16 Veterans and 
randomize to two groups of 8. However, if recruitment is slow, the smallest randomization pool allowed will be 
8 (4 Veterans assigned to each group). If recruitment is ahead of pace, the largest randomization pool allowed 
will be 20 (10 Veterans assigned to each group).  
 
When a cohort large enough is available, randomization into STEP-Home or PCGT will occur and participation 
in the study begins (i.e., Time 1; T1: Pre), during which we will consent, administer the baseline assessments, 
randomly assign to either the STEP-Home or the PCGT arm, and schedule the treatment sessions. All 
participants will be assessed at the following 5 outcome points: Screening, at randomization (T1: Assessment), 
during treatment 4-week skills check (T2: Brief Skills Check), during treatment 8-week skills check (T3: Brief 
Skills Check), post-intervention (T4: Assessment), and at 3-months follow up (T5: Assessment). Assessments 
and skills checks are all self-report; therefore, blinded assessors are not required. Participants who decide to 
leave the program early will be asked to complete all assessments via secure Qualtrics link sent in 
MyHealtheVet or via postal mail service according to the RCT timeline following the intent-to-treat format, but 
will not be required to do so. Veterans will participate in their assigned treatment arm 1 day/week for 
approximately 2 hours. Replicating our SPiRE feasibility and preliminary effectiveness study [1], staff members 
will work in pairs when running groups. These same two staff members will offer to meet individually with 
Veterans before or after group approximately 4 to 6 times/workshop; it will be the Veterans’ choice whether 
they participate in these individual meetings. 
 
Assessments (T1, T4, and T5) may be done in person or online (see Data Security Section for description of 
Qualtrics online data entry). Brief Skills Checks (T2 & T3) may also be done in person or online. 
 
 
 
• 
Assessments = T1, T4, and T5; Reimbursement = $20 
• 
Brief Skills Checks = T2 & T3; Reimbursement = $0 
 
(c) Human Studies: 
 
cr Randomtze 
STEP-Home 
(12 weeks) 
~
GJ 
FOGT 
(il.2 weeks), 
~GJ 
T4 
T4 
Follow up 
(12 weeks) 
Foirnwcrp-
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• · • • • l • • • • • • • • • • • • • • • • • • • • • • ·······I······· I········· f · · · · • · · · · · · · · · · · · · · · · · · · · · ~- · · · · · 
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4 
8 
12 
24 weeks 
Randomi;iati,on Flgure. Tl = Baseline As.sessment; T2 = 4-week Ski Is. oheck; T3 = 8-week Skllls 
check; J.4 = 12-week Post-lnterventlon1 Assessm ent; TS = 24-week 
llow-up A.ss.essment. 

 
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Participants and Recruitment: All possible participants recruited for this study will be Veterans. Participants will 
be referred from three primary sources: 1) Clinical services; 2) TRACTS; (3) Community partners, other VA 
clinical services, and advertisements.  
1) Clinical services: VA Boston Healthcare System (VABHS) clinics often include: Center for Returning 
Veterans, Polytrauma, Primary Care, Neuropsychology, Psychology, Neurology, Psychiatry, and PTSD 
Clinics (Behavioral Health and Women’s Division). IRB-approved study brochures will be placed in clinics, 
and staff members working in these clinics will share approved recruitment materials for STEP-Home and refer 
Veterans who may be appropriate for the trial. 
2) TRACTS: Current/former TRACTS participants at TRACTS Boston may be told about STEP-Home by 
TRACTS study staff. Additionally, a recruitment letter will be sent to former TRACTS participants to explain the 
study to them and give them STEP-Home study staff contact information should they wish to learn more about 
participating.  
3) Other recruitment sources may include existing community partners (e.g., schools, Veteran Outreach 
coordinator David Hencke), VA outpatient clinics/Vet Centers/CBOCS, advertisements, social media (e.g., 
Facebook), and our website (www.stephome.hms.harvard.edu). Any new advertisements will be reviewed by 
IRB before implementation. Additionally, given the possiblility that STEP-Home workshops may be conducted 
via telehealth methods and advertisements may reach Veterans outside of Massachusetts, we intend to make 
STEP-Home available to Veterans nationwide. 
4) Recruitment at the Houston site will be under the direction of Houston site PI, Ricard Jorge, and will be 
overseen by their IRB. 
5) ) The Veterans Affairs/Department of Defense Identity Repository (VADIR), a VA database containing 
military personnel information from the DOD. We will receive quarterly updates from VADIR; the VADIR 
transfer server (vaausvdrxfr20.aac.va.gov) automatically pushes the quarterly file to our study server, via 
secure transfer behind the VA firewall. 
 
Each month, we will send recruitment letters to a random sample of up to 1000 newly separated Veterans 
received from VADIR. Specifically, this means that our first month of recruitment will involve sending 
recruitment letters to up to 1000 randomly selected Veterans who separated from service during the three 
months prior. The next month, we will exclude Veterans who already received a letter from us and extract 
another group of up to 1000 Veterans from the larger pool of eligible Veterans who separated from service 
during the three months prior (which will comprise any Veterans who are still within the window of eligibility and 
were not selected the previous month as well as any Veterans who are newly separated in the month between 
recruitment waves). This process will continue until our enrollment target is met. The recruitment letter will 
briefly describe the study and invite them to contact the study team if they are interested in learning more 
about participating. They will also have the option of sending back an “opt out” postcard in a pre-paid envelope 
if they do not wish to be contacted again.  
 
Potential Veterans identified through VADIR will initially be contacted by the STEP-Home study via a written 
outreach letter (sent via USPS mail or email). If the Veteran does not reply to STEP-Home’s initial outreach, 
STEP-Home staff will make up to two attempts to contact the Veteran by phone, and the phone outreach 
attempts will begin at least 1 week after the written outreach letter was sent. 
 
Inclusion Criteria: Participants will be (1) Post-9/11 Veterans who report some reintegration, readjustment, or 
anger difficulty – i.e., Veterans who report “some difficulty” (Likert rating) on at least one of the primary 
measures: M2CQ; PDRI; STAXI-2; (2) 18-75 years old; (3) English-speaking (sessions will be conducted in 
English); and (4) Agreeing to participate (i.e., completion of ICF/HIPAA). 
 
Exclusion Criteria: Participants will be excluded for (1) schizophreniform disorder/active psychosis; (2) bipolar 
disorder; (3) active suicidality/homicidality requiring crisis intervention; (4) other severe psychiatric disorders 
prohibiting appropriate group participation; (5) neurological diagnosis prohibiting appropriate group 
participation (excluding TBI); (6) current substance dependence; (7) *current participation in any other form of 
active behavioral therapy at the time of enrollment (e.g., Cognitive Processing Therapy, cognitive rehabilitation 
for mTBI, or other psychotherapy). 

 
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*For any potential participants who are currently participating actively in another treatment, they will be invited 
to participate in the next available cohort after their current treatment is complete. 
 
Enrolled STEP-Home participants will be instructed not to schedule initiation of another behavioral therapy until 
the 12-week intervention is complete. Importantly, Veterans will be allowed and encouraged to initiate any 
other treatment at the conclusion of STEP-Home or PCGT, even during the 12-week follow up. If another form 
of intervention is pursued during the actual 12-week intervention despite instruction to wait, we will allow 
participants to remain enrolled and track that information for use in statistical analyses similar to the 12-week 
post-intervention follow up period. We will, however, seek replacement participants for those who do this so 
that our statistical power is not diluted. Any necessary treatment for psychiatric crisis will also be allowed and 
tracked. Treatment enrollment and health utilization data will be collected at T1, T4, and T5 via self-report 
format and via CPRS chart review (please see Secondary Outcome Measures and Baseline Characteristics, 
protocol page 7). Psychotropic medication (and related visits) will be allowed if stable. 
 
Note: If Veterans enrolled in STEP-Home express active suicidality/homicidality requiring crisis intervention, 
study staff will follow typical VA procedures including contacting Suicide Prevention Program and/or referring to 
Urgent Care. STEP-Home will not be seeing patients during off hours at the VA. The lead investigator (Fortier) 
and lead therapist (Kenna) are licensed psychologists. Appropriate safeguards will be in place if screening 
procedures, assessments, or intervention sessions cause any psychological distress or a psychiatric 
emergency emerges among participants. Staff will provide appropriate referrals and assess risk. If a psychiatric 
emergency is reported by a participant in the context of the study, the site PI, or in case of her unavailability, a 
Co-I (Dr. Kenna) will contact the disclosing participant by phone, assess for risk and safety, and provide the 
participant with appropriate referrals. We will utilize access to local and national mental health resources 
available through the VA, including the suicide prevention hotline, risk assessments through Mental Health 
during regular business hours (Psychiatry Urgent Care), or the Psychiatrist on call during off hours. All potential 
collaborators on these research activities will have completed comprehensive training in the areas of research 
ethics, protection of human subjects, and suicide prevention. They will also have completed all VA required 
trainings pertinent to cyber security, VHA privacy policy (HIPAA), research data security and privacy, ethical 
principles of human subjects’ protection, etc., as required by local IRBs. 
 
Informed Consent Process: The informed consent process will take place prior to participation in the study 
either by mail, online via VA-approved technologies, or in quiet designated testing space with the Project 
Coordinator and/or other trained study staff members. If informed consent takes place online, the process is 
done individually for each participant with one study staff member; the consent process will never take place in 
a group format with more than one participant at a time. During the informed consent process, participants are 
informed that at any point in time, they are welcome to ask questions or bring up any issues that may concern 
them. They can tell the research assistants, project coordinator, and/or the investigator. If the investigator is 
not immediately available, the research assistants and project coordinator will relay the participant's question 
or concern to the investigator as soon as she is available. Participants are also given the investigator's phone 
number, and they are welcome to call her at any time during or after their study participation is completed. 
 
If consent takes place via mail or online: 
 
• 
Consent forms will be mailed via postal mail or sent via MyHealtheVet. 
Consent forms will be reviewed with study staff and verbal consent will be obtained online on VA-approved 
technologies at the Pre-Visit (online questionnaire session), which is conducted in a private, individual session 
with one participant at a time. The participant will then be asked to sign the consent on camera via approved 
online platform and either: return signed document by mail (USPS); fax the signed document; taking a digital 
image and sending it via Azure RMS encrypted email;by study staff obtaining a screen capture of the signature 
page; or by electronic/digitial signature. For the option of electronic/digital signature, this can be done by a 
signature made on a touch device or computer mouse, or through the use of DocuSign software. 
 
Payment: Participants will be reimbursed $20 for participation in assessments at Weeks 1, and 12. For the 
follow-up assessment at week 24, participants will be reimbursed $40. There is no compensation for the skills-
checks at weeks 4 and 8. Maximum total payment for assessments will therefore be $80. Participants will also 
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be reimbursed up to $120 for travel to/from the workshops over the 12 weeks. Participants will receive 
$10/workshop for each workshop attended, regardless of distance/time traveled. Total maximum payment is 
therefore $200. Payment may be in the form of a check, debit card, or electronic direct deposit.  
 
October 2022 protocol update: If a participant signed a previous version of the consent form when direct 
deposit was not an option, we will contact them at the time of their next scheduled assessments and give them 
the option of re-signing the newer consent form so they can receive payment via direct deposit, if they so 
choose. 
 
 
Methods and Materials: 
 
Group Treatment Modalities 
 
(1) Treatment Group = STEP-Home. This group will meet for ~1.5 - 2 hours a week for 12 weeks. The core 
skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and 
then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. 
Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual 
sessions. Additional 30-minute individual skill building and goal setting sessions (see STEP-Home Manual and 
[1] for additional information) may occur approximately 4 - 6 times over the 12 weeks (based on individual 
Veteran needs). All Veterans will be offered individual skill building sessions. We have observed in past STEP-
Home groups that not all Veterans chose to take advantage of these sessions, but they will be offered to all of 
the participants. Advisors support practice of PS/ER/AT strategies.  
 
Core Skills: 
 
Problem-Solving (PS): Participants receive 12 45-minute sessions of group PS using the five-step approach to 
PS [56;57]. An acronym (SWAPS) has been developed based on these steps to help participants remember 
them: Step 1: Stop! Is there a problem? Step 2: What is the problem? Step 3: Alternatives and options Step 4: 
Pick and Plan Step 5: Satisfied? Veterans learn the approach using a variety of Veteran-centric examples with 
repetition in multiple contexts allowing the process to become habitual or rote.  
 
Emotional Regulation (ER): Participants receive 12 45-minute sessions of group ER drawing on the principles 
outlined by D’Zurilla et al. [58; 59] and their application to TBI by Rath [60]. Cognitive behavioral techniques 
adapted to the unique cognitive needs of Veterans will be used [60, 61]. Emotions inevitably affect (positively 
or negatively) PS; therefore, ER is crucial to effective PS and anger/impulse control. To maximize 
generalization, ER will be contextualized by focusing on real-life Veteran problems. Group members are 
encouraged to share a problem that they have experienced and apply ER to that problem. As Veterans 
become more aware and adept at this process, they are taught to identify new, healthy alternative behaviors.  
 
Attention Training (AT): AT is based on Attention Process Training (APT-II) [62] and Sohlberg et al.’s  [63] 
model of attention. Attention is made up of two categories: simple attention (focused and sustained attention) 
and complex attention (selective, alternating, and divided attention). We use these principles to guide 
remediation of attentional impairments through the application of individually tailored feedback including 
compensatory and generalization strategies. Group discussions are focused on how individual attentional 
difficulties can be related to symptoms of PTSD, TBI, and/or other conditions. 
 
Veteran-specific Content (see [1] and STEP-Home Manual for more information): Veteran-specific content 
is introduced and used for PS/ER/AT skills training throughout the 12-week workshop (Figure 4). The skills 
training that Veterans receive is fully contextualized into the content areas. We have found that Veterans 
typically demonstrate difficulty adjusting from military to civilian contexts based on fundamental differences in 
the structure of these contexts. Similar to Battlemind training [45], we use Veteran-specific content areas to 
demonstrate that the habitual skills needed to survive in combat may cause problems if not adapted to the 
civilian world. Psychoeducation in the various content areas is provided and group leaders elicit examples from 
Veteran participants in the content areas to practice PS/ER/AT in group. Content domains are described in 

 
9
detail in the STEP-Home Manual and include: Vocational, Community Reintegration, Psychoeducation & 
Destigmatization (gateway to VA care), Substance Misuse, Anger Management, Veteran-to-Veteran Support, 
Family/Support System Involvement. 
 
(2) Comparison Group = PCGT. A nonspecific comparison design [64] was selected to allow greater certainty 
that STEP-Home treatment effectiveness is due to specific aspects of the key ingredients of the experimental 
therapy (STEP-Home) and not merely to nonspecific therapeutic factors. PCGT was initially developed by 
Schnurr et al. [65] to include all elements of effective PTSD treatment that are not specifically trauma-focused. 
PCGT is a credible and clinically acceptable treatment often used as a control condition in PTSD trials with 
notably low drop out rates [65-67]. It is a nonspecific and supportive intervention to control for the nonspecific 
benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). 
PCGT is fully manualized for group delivery and can be easily matched to STEP-Home as an active control 
arm (e.g., [65-67]). It will focus on identifying and discussing current life stressors that contribute to 
reintegration difficulties, psychoeducation, and promotion of wellness and physical health. Similar to the STEP-
Home group, PCGT will contain homework assignments, involving monitoring diaries of stressful situations and 
when symptoms cause impairment in social and occupational functioning, and will also meet for ~1.5 - 2 hours 
a week for 12 weeks. Staff members will also offer to meet individually with Veterans enrolled in PCGT before 
or after group approximately 4 - 6 times over the 12 weeks. PCGT and individual sessions will not include the 
components that form the key ingredients or core skills of STEP-Home: CBT-based active PS, ER, or AT. 
Rather, PCGT employs Yalom’s [68, 69] model of group therapy with a “here-and-now” focus and emphasizes 
the process of interpersonal learning, group cohesion, and group support. Although focus of group discussions 
will often be on group members’ current problems, active CBT-based directive PS techniques used in STEP-
Home will not be employed in the PCGT control condition. Content for group discussions will mimic STEP-
Home topics including: Vocational, Community Reintegration, Psychoeducation & Destigmatization (gateway to 
VA care), Substance Misuse, Anger Management, Veteran-to-Veteran Support, and Family/Support System 
Involvement. 
 
Outcome Measures 
 
All measures used (except those developed for STEP-Home during the feasibility study) are commercially 
available, have evidence of psychometric soundness or responsiveness to the interventions proposed, and 
have been used in previous intervention studies of populations with PTSD and TBI. Assessments do not 
require blinding because all outcomes are self-report. The time points at which the different outcome measures 
will be administered are shown in the Table below that follows the listing of outcome measures. 
 
(1) Primary Outcome Measures 
The primary outcome measures may include the following assessments: 
• 
Military to Civilian Questionnaire (M2C-Q): A 16-item measure of post-deployment community 
reintegration in post-9/11 Veterans that assesses six domains (interpersonal relationships, productivity 
at work, school or home, community participation, self-care, leisure, and perceived meaning of life). 
• 
Post-Deployment Readjustment Inventory (PDRI): A 36-item measure of readjustment in post-9/11 
Veterans with six subscales (career challenges, social difficulties, intimate relationship problems, health 
concerns, concerns about deployment, and PTSD symptoms). 
• 
State-Trait Anger Expression Inventory (STAXI-2): A 57-item widely used measure to assess state 
anger, trait anger, and anger expression with three subscales (trait anger, anger expression, and anger 
control). 
 
Core Skills Measures 
The core skills measures may include the following assessments: 
• 
Problem Solving Inventory (PSI): Measure of PS Confidence, Approach-Avoidance Style and Personal 
Control. 
• 
Difficulties in Emotion Regulation Scale (DERS): Measure to assess multiple aspects of emotion 
dysregulation 
• 
Attention-Related Cognitive Errors Scale (ARCES): Measure of everyday performance failures arising 
from brief failures of sustained attention. 

 
10 
 
(2) Secondary Outcome Measures 
The secondary outcome measures may include the following assessments: 
 
Mental Health 
• 
PTSD Checklist for DSM-5 (PCL-5): A 20-item measure of PTSD updated for DSM-5. 
• 
Depression Anxiety and Stress Scale (DASS-21): A 21-item measure of current depression, anxiety, 
and stress. 
• 
Neurobehavioral Symptoms Inventory (NSI): A 22-item measure of current post-concussive symptoms. 
 
Functional/Vocational 
• 
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0): Measures functional 
states in six domains (understanding and communicating, getting around, self care, getting along with 
people, life activities (work/school), and participation in society). 
• 
Satisfaction with Life Scale (SWLS): A 5-item measure of satisfaction with life. 
• 
Treatment/Activities Survey: Assesses engagement in treatment, school, work, and life activities. 
• 
Barriers to Employment Success Inventory (BESI): A measure of obstacles to employment in five areas 
(Personal/Financial, Emotional/Physical, Career Decision-Making and Planning, Job-Seeking 
Knowledge, and Training/Educaiton). 
• 
Average # hours worked: Number of hours/month in the month before STEP-Home and in each month 
of the intervention, WLC, and post-treatment monitoring. 
 
Cognitive 
• 
Frontal Systems Behavior Scale (FrSBe): Measures apathy, disinhibition, and executive dysfunction. 
 
Baseline Characteristics (captured via self-report measures and/or CPRS chart review) 
• 
Demographics 
• 
Deployment data 
• 
Active problems/diagnoses 
• 
Medication list 
• 
Health utilization data 
• 
WTAR 
 
(3) Treatment Adherence and Program Satisfaction Measures 
 
Feasibility/Adherence 
• 
Supervisor Adherence: Supervisor Assessment of Therapist Adherence to Content 
• 
Therapist Adherence: Therapist Self-Assessment of Adherence to Content 
• 
Fidelity to Content: Participants rate fidelity to content 
• 
Program Satisfaction: Participants rate interest, pace of delivery, and relevance of workshop goals with 
global and specific satisfaction ratings 
• 
Participant Skills Self-Rating: Knowledge of core skills/key therapeutic ingredients  
• 
Connectedness to VA services measure: Participants rate perceptions of engagement to treatment and 
VA 
 
Therapist adherence to each intervention (STEP-Home and PCGT) will be rated by a supervisor. Therapists 
will be informed of these adherence ratings during training. Treatment adherence is an essential element of 
RCT design and these ratings will be required for all therapists. 
 

 
11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analytic Plan & Power Analysis 
* Analytic Plan & Power calculations may include references to the full study sample, including Phase 2 
recruitment at site 2 (Houston). 
**The February 2023 project modification/1-year extension requested funds to complete Cohort 19 (ongoing at 
the time of the project modification request) and enroll one additional cohort (Cohort 20) to ensure sufficient 
power for Aim 1 (Hypotheses 1A, 1B) and Aim 2, and to support final data analysis and manuscript submission 
in the last 6 months of the 1-year cost extension (October 2023 – March 2024). Of note, the study’s Aims, 
listed below, remain unchanged with the project modification. The only changes involve an increase in our 
targeted enrollment number, to ensure sufficient power, as enrollment and measures completion rates to date 
are slighty under our original goals. 
 
 
Data Management. Data entered in the database will be verified and quality assurance procedures will be 
followed; Human Subjects (Accuracy/ Integrity of Data); Data management plan (“09_VA_DMAP”). 
 
For continuous variables, the mean, median, standard deviation, minimum, maximum, interquartile range, 
and sample size for each intervention group will be reported at each time point. For categorical variables the 
frequency distribution will be reported for each treatment group.  
 
Baseline Comparability. While no substantial differences between intervention groups are anticipated given 
randomization, we will use summary statistics, graphical techniques such as boxplots, and univariate 
analyses to compare baseline characteristics of groups. Pre-intervention values will be compared between 
Table 9. Assessment by 
Tl 
T2 
T3 
T4 
TS 
Domain 
Screening 
Baseline 
Skills 
Skills 
Post-
Follow 
check 
check 
Intervention 
up 
Domain 
0 weeks 
4weeks 
Sweeks 
12 weeks 
24weeks 
Baseline Characteristics 
Demographics 
X 
Deployment data 
X 
Active problems/diagnoses 
X 
X 
X 
X 
Medication list 
X 
X 
X 
X 
Health utilization data 
X 
X 
X 
X 
WTAR 
X 
Primary Outcomes 
M2CQ 
X 
X 
X 
X 
PDRI 
X 
X 
X 
X 
STAXl-2 
X 
X 
X 
X 
Core Skills/Key Ingredients 
PSI 
X 
X 
X 
X 
X 
DERS 
X 
X 
X 
X 
X 
ARCES 
X 
X 
X 
X 
X 
Secondary Outcomes 
Mental Health 
PCL 
X 
X 
X 
DASS-21 
X 
X 
X 
NSI 
X 
X 
X 
Functional/Vocational 
WHODAS-2.0 
X 
X 
X 
SWLS 
X 
X 
X 
Treatment/ Activities 
Survey 
BESI 
X 
X 
X 
Average hours worked 
X 
X 
X 
Cognitive Outcome 
FrSBe 
X 
X 
X 
Feasibility & Program 
X 
X 
X 
X 
X 
Satisfaction 

 
12 
STEP-Home and PCGT groups using t-tests and chi-squared tests, as appropriate, to determine if the groups 
are balanced with respect to baseline characteristics. This comparison will allow us to identify potential 
confounders and moderators to be included in multivariate analyses. Clinical covariates include: age; 
education; diagnosis of TBI history; PTSD, mood disorder, anxiety, substance use, chronic pain, sleep quality. 
 
Statistical Methods by Research Aims. The primary analysis for each aim will use an intent-to-treat (ITT) 
approach (i.e., all randomized subjects will be used in the analysis). ITT is optimal since it provides the least 
biased estimate of the treatment effect and the randomization balances STEP-Home and PCGT groups on 
known and unknown baseline confounders. This approach is appropriate for the proposed study given an 
anticipated low attrition rate of ~17% (based on attrition rates observed in our SPiRE study and Mt. Sinai’s 
STEP RCT). We will implement quality assurance procedures to minimize protocol deviations and ensure 
correct treatment assignment according to the randomization. As a sensitivity analysis, we will conduct a per-
protocol analysis in the subset of participants who complete an adequate amount of treatment (≥80% of 
weekly sessions). We will assess the assumptions of homogeneity of variance and normality of residuals for 
each regression model and apply an appropriate transformation of the outcome if needed. We will address 
missing data, under the assumption of missing at random, using multiple imputation. Any subject 
characteristics associated with both the treatment group and primary outcome measure will be adjusted for in 
the final statistical model as specified in each aim. 
Aim 1. Examine treatment effects of STEP-Home on primary outcomes relative to PCGT:  
Hypothesis 1A. Participants randomized into the STEP-Home intervention will show improvement on 
reintegration, readjustment, and anger post-intervention (expressed by lower scores; less difficulty). 
Military to Civilian Questionnaire (M2CQ), Post-Deployment Readjustment Inventory (PDRI), and State-Trait 
Anger Expression Inventory (STAXI-2) scores post-intervention (T4) < baseline (T1) 
Statistical Methods: Paired t-tests will evaluate the difference between pre- (T1) and post-scores (T4), with a 
separate analysis for each primary outcome. 
Hypothesis 1B. Participants randomized into STEP-Home will show greater improvement in primary 
outcomes as compared to PCGT.  
1B.1: Change scores baseline (T1) to post-intervention (T4) STEP-Home > PCGT  
1B.2: Post-intervention (T4) primary outcome scores STEP-Home < PCGT  
Statistical Methods: Mixed models (PROC MIXED in SAS) will evaluate pre-post differences, with a separate 
model for each primary outcome. The Satterwaite option will be used to account for the clustering of subjects 
within cohorts (identified in Section 6.2) and calculate degrees of freedom accounting for any missing data. 
Group (STEP-Home/PCGT) will be the between-subjects factor and time-point (T1/T4) will be the within-
subjects factor. We hypothesize that there will be a significant interaction between group and time-point, with 
a larger improvement between pre- (T1) and post-scores (T4) in STEP-Home than PCGT. While we do not 
anticipate a significant interaction by cohort or site, we will evaluate the 4-way interaction and all 2-way and 3-
way interactions for time-point, group, cohort, and site. The model will be rerun removing any non-significant 
interactions. Linear regression will be used to evaluate the difference in post-intervention (T4) by group. The 
final mixed and regression models for each outcome will adjust for any identified confounders.  
Aim 2. Examine maintenance of treatment effects on primary outcomes:  
Hypothesis 2: Treatment effects will be maintained at follow up in both groups.  
Differential treatment effect of STEP-Home over PCGT T4 will be maintained at T5 
Statistical Methods: Mixed models, as described under Hypothesis 1B. We hypothesize that there will not be a 
significant interaction between group and time-point but the main effect of group will remain significant. Since 
subjects may initiate behavioral therapy post-intervention, we will conduct a secondary analysis to evaluate 
the impact of additional psychotherapy on the treatment effects. We will stratify by group and post-intervention 
therapy status (therapy/no therapy) and examine paired t-tests within each of the 4 strata.  
Exploratory Aim 1. Explore treatment effects of STEP-Home on measures of mental health, functional 
and vocational status and cognitive secondary outcomes targeted indirectly in the workshop. 
Statistical Methods: Paired t-tests and mixed models, as described in Primary Aims 1 and 2.  
Exploratory Aim 2. Acquisition of core skills (problem solving, emotional regulation, attention 
training) will mediate the effect of treatment on the primary outcomes post-intervention and follow up. 
Veterans demonstrating greater acquisition of core skills will evidence greater improvement in reintegration, 
readjustment, and anger post-intervention (T4) and at follow up (T5). 
Statistical Methods: Exploratory mediation analyses will evaluate the potential causal pathway between 
treatment allocation and each primary outcome, with the core skills as mediators, using the SAS mediation 

 
13 
macro developed by Valeri and VanderWeele [88]. We will run separate mediation analyses for each primary 
outcome and with each core skill (PS, ER, AT) as the mediator. We will evaluate acquisition of skills at two 
separate times during intervention (T2 and T3) as mediating the effect of treatment on post-intervention (T4). 
We will also examine skill acquisition at post-intervention (T4) as mediating the effect of treatment at follow up 
(T5). The mediation analysis will fit two models: (1) linear regression with the primary outcome as the 
dependent variable, group as the independent variable, and the mediator as a covariate and (2) linear 
regression with the mediator as the dependent variable and group as the independent variable. Both models 
adjust for any identified group-outcome and mediator-outcome confounders. The direct and indirect 
(mediating) effects are calculated from the beta coefficients of these two models and the 95% confidence 
intervals calculated using bootstrap (1000 replications). We will conduct a secondary analysis to evaluate the 
impact of any behavioral therapy initiated post-intervention for the post-intervention mediation analysis (i.e. 
core skills mediating effect T4 - T5), stratifying by post-intervention therapy status (therapy/no therapy). 
 Power Analysis. Power calculations are made for the full study, including Phase 2 recruitment at site 2 
(Houston). Power calculations were conducted on the primary aims (Aims 1 and 2) to observe an effect of 
Cohen’s d=0.44 or larger at one-tailed p<.05 and ≥80% power. We selected a one-tailed p-value because all 
primary hypotheses were stated a priori as one-sided. We anticipated a small to medium effect size based on 
the Cohen’s d=0.44 observed in the subset of our SPiRE feasibility study (n=35) who reported at least some 
difficulty on M2CQ, WHODAS, or Impulsive Aggression Scale (IAS). While we did not specifically collect pilot 
data on the PDRI or STAXI-2, we assume the effect size will be at least as strong as d=0.44 observed on the 
proxy measures (WHODAS and IAS) since the PDRI and STAXI-2 are more sensitive and specific to post-
9/11 Veterans. We further applied a conservative attrition rate of 20%, based on the attrition observed in our 
SPiRE feasibility study [1] and in Mt. Sinai’s STEP RCT [2]. The univariate paired t-tests evaluating the 
improvement (Hypothesis 1A) and post-intervention maintenance (Hypothesis 2) of primary outcomes scores 
within the intervention groups required a total sample size of 83 after accounting for attrition. For Hypotheses 
1B, the sample size was further adjusted to account for the clustering of subjects within the randomization 
cohort by applying an inflation of variance factor [71,89]. We used an interclass correlation of r=0.04 as 
observed in a similarly designed group therapy RCT [65]. For the univariate post-intervention and change 
score analyses, we would need a total sample size of 208 after accounting for clustering and attrition. Thus, a 
total sample size of 208 is sufficient to power both primary aims. 
 
 
Potential Risks 
 
Potential Risks: Overall, this study poses low risks to the subjects. There is an extensive literature, which 
describes experimental techniques similar to those used in the proposed study, which indicates that these 
paradigms pose limited risks to subjects. No deception is involved in any of the examinations or interventions, 
and subjects are fully debriefed before leaving the study. During the self-report questionnaires, outcome 
measurement, and the intervention, subjects may become anxious or fatigued. Some people may become 
mildly uncomfortable about being asked about their medical, psychological, or vocational history. While the 
psychological interventions can be associated with emotional distress, every effort will be made by the study 
staff to make the process as comfortable as possible; distressed participants will be followed up with to 
determine if further treatment is needed. Subjects will be made aware throughout the workshop that they are 
free to discontinue their participation at any time.  
 
STEP-Home & PCGT Intervention/Workshop: Previous research shows that cognitive behavioral interventions 
are effective at decreasing psychological and cognitive complaints. The cognitive intervention Short Term 
Executive Plus (STEP), selected by this proposal, is currently considered to be an effective form of cognitive 
behavioral therapy for TBI and has been demonstrated to adapt well and be tolerable to the OEF/OIF 
participant group in our previous SPiRE award. Present Centered Group Therapy (PCGT), selected for the 
active control arm for this proposal, is considered to be an effective alternative supportive treatment for PTSD 
for those unable to tolerate trauma-focused interventions. We are mindful that discussing psychological 
symptoms, vocational issues, and life stressors can sometimes increase anxiety. 
 
Adequacy of Protection Against Risks 
 

 
14 
Recruitment and Informed Consent: Recruitment and consent procedures follow VA and HIPAA regulations. In 
keeping with the human studies regulations of the institutions involved, before participating in testing, 
participants will have the nature of the experimental design explained to them. The non-clinical (research-
based intervention) nature of the testing will be made clear. Participants will be given relevant consent forms to 
review and sign. The form(s) will be reviewed point-by-point with the potential subject by one of the research 
staff members before the subject's signature is requested.  
 
Protection Against Risk:  
Questionnaires: Participants will be informed that if they do not wish to answer specific questions or wish to 
terminate the session, they will be able to do so. 
Intervention/Workshop: Participants distressed by any increase in symptoms during STEP-Home or PCGT will 
be asked to notify the researchers so that additional support can be provided. It is also possible that STEP-
Home and/or PCGT will not help improve symptoms. A licensed psychologist or psychiatrist will be available 
during all group and individual sessions. If a participant becomes a safety risk to him/herself or others during 
participation in this study, he/she will be referred to a psychiatric emergency room for further evaluation. All 
STEP-Home and PCGT sessions will be conducted during regular VA hours to ensure that Urgent Care 
Services are available if required.   
 
Confidentiality: All copies of records and behavioral outcomes will be stripped of identifying information and 
then coded. The codes will be kept in a locked safe or a password-protected database in an encrypted 
computer behind the VA firewall. Only key laboratory personnel will know the code. All computer files or printed 
data used for analysis will also be de-identified. Participants’ confidentiality will be protected by never 
associating a subject's name with results in any published or otherwise publicly presented report.  
 
 
Data Safety Monitoring Board (DSMB) 
STEP-Home established a Data Safety Monitoring Board (DSMB) and standard operating procedures (SOP) of 
the DSMB in early 2020. The DSMB is comprised of individuals from outside of our research laboratory 
(TRACTS) with expertise in the patient population and disorders being studied in this trial (e.g., Veterans, 
PTSD, TBI), the conduct and methodology of clinical trials, and biostatistics/epidemiology; the DSMB members 
are Suzanne Pineles, Brian Smith, and Jennifer Wachen, all of whom are VA Boston staff.   
 
Items reviewed by the DSMB include the following: 
 
-Adverse events (AE) and unanticipated problems (UP) 
 
-Data quality and completeness 
 
-Performance of individual centers/sites (e.g., Boston –Years 1 - 5 and Houston –  
Years 3 - 5) 
 
-Compliance with recruitment and retention goals 
 
-Protocol adherence 
 
-External factors that may influence study ethics or patient safety 
 
DSMB will also review all AE’s and UP’s within 5 working days from learning of the event/problem. Below 
please find a schematic that illustrates AE reporting procedures.  
 
To date (March 1, 2023), the DSMB has held meetings on the following dates: 
March 3, 2020 
March 22, 2021 
March 21, 2022 
The fourth annual DSMB meeting will be held in the spring of 2023. 
Reports from each of these annual meetings have been submitted to and acknowledged by IRB. 
 
Adverse Event Reporting  
The study PI and staff will promptly notify the IRB and DSMB of any adverse events or unanticipated problems; 
the required forms will be submitted no later than 5 working days from learning of the event/problem. All severe 
adverse events will be reported to the IRB consistent with VA’s requirements. If a determination about 

 
15 
continued subject participation cannot be made according to the criteria defined above for adverse event 
reporting by the PI, then the adverse event report will be faxed to the chair of the Data and Safety Monitoring 
Board (DSMB), who will make a decision along with members of the Board. 
 
 
 
Potential Benefits of the Proposed Research to the Participants and to Others 
 
This study is being performed to advance medical knowledge. While it is expected that most participants may 
experience some clinical benefit from participation in the treatment, we cannot guarantee any direct benefit will 
accrue to study participants. However, given that this study will evaluate the effects of a known standard 
clinical therapy, the known risks are reasonable in relation to the general knowledge and potential clinical 
benefit for Veterans that will be gained to ultimately help others. Although direct clinical benefit to the 
participants remains theoretical, participants have often enjoyed participating in medical research in general in 
the past and have enjoyed the opportunity for contact with other post-9/11 Veterans and research staff 
members. 
 
Importance of the Knowledge to be Gained 
 
Identifying and treating specific factors that contribute to community reintegration difficulties after serving our 
country in a warzone is of utmost importance in providing adequate care to our Veterans. The identified risks 
noted in this study are reasonable in relation to the general knowledge that will be gained and that may 
ultimately help many Veterans.  
 
Data Security 
 
All outcomes are psychometrically sound, widely used instruments. The manual and therapist training 
workshops will be created for consistent administration, inter-therapist reliability, and adherence to the STEP-
Home and PCGT interventions in this proposed study. Training includes direct observation, audiotaping, and 
participation in weekly supervision and treatment adherence meetings.  
 
All questionnaires will be completed using Qualtrics on a VA-approved iPad or a VA laptop, or non-VA, non-
networked computer.  Qualtrics is a platform used to administer surveys/questionnaires by organizations and 
researchers nationwide, including VA medical centers, and has secure transmission services that meet all 
federal requirements.  If questionnaires are completed off-site, non-VA, non-networked computers will be used 
using the secure Qualtrics link sent in MyHealtheVet or via postal mail service.  Qualtrics has a secure offline 
app to use for data collection; the data collected are transferred to the Qualtrics secure server using a VA OIT 
issued encryped wireless hotspot.  Data collected on VA and non-VA devices will be transmitted with research 
codes only.  No personally identifiable data will be transmitted.  Access to data will be limited to authorized 
study personnel via login to a secure site.  The information collected in Qualtrics will have a backup copy 
stored on the Qualtrics server.  The statistician manages the data entry and monitors the quality assurance 
Boston 
Ex emal 
VAIRB 
DSMB 
L 
Pl: Fortier J 

 
16 
procedures developed at TRACTS.  Additionally, the statistician uses statistical software (SAS) for additional 
quality assurance and creates the final analytic database used for analyses. There is an exisiting contract 
between TRACTS and Qualtrics that this STEP-Home study will also be able to use. 
 
The link between the research code and the participant’s identity will be stored in a separate file maintained on 
a separate secure, password-protected VA computer drive or in a locked file in a locked room accessible only 
to authorized research staff. All paper records will be stored in a locked filing cabinet behind a locked door.  
The signed informed consent form and HIPAA authorization form will be stored in a separate location from the 
participant study data. All locked cabinets are only accessible by approved study staff. The key is kept in a safe 
behind a locked door, with only a limited number of staff with access to the safe.  These staff will verify the staff 
member requesting access to the locked cabinet are currently on the study protocol and will maintain a log of 
each access request.  
 
All electronic databases related to the study will be stored on double-password protected servers behind a 
firewall.  The TRACTS computer system is accessed via desktop computers situated in TRACTS offices in VA 
Boston Healthcare System that conform to all VA OIT directives.  The desktop computers require 
authentication for access and these computers are assigned to authorized staff only.  User accounts are 
promptly disabled and deleted for unauthorized staff who are no longer affiliated with projects for which access 
to the server is necessary.  Access to the data server will be gained only through request of the PI to the 
network systems administrator, and with the consent of the TRACTS Director.  Access may only occur through 
PCs requiring unique user identification code and an individually unique password.  User identification codes 
limit access to specific directories and files.  The accounts and passwords comply with existing VA policies and 
procedures for computer access.  Only approved VA personnel assigned to be on the study who are research 
credentialed and are up to date with all the required VA training will be allowed to be on the study. All study 
personnel must be approved by the VABHS IRB and R&D committee to be on the study team.  
 
In the event that the users of the data covered by this agreement loses confidential or Privacy-protected data, 
or the data is stolen or removed from designated locations, or used or disclosed for purposes other than 
outlined in this agreement, the custodian must report the incident immediately upon discovery of the incident to 
the ISO, Privacy Officer, and to the employee’s/other user’s immediate supervisor. Senior management should 
be informed immediately by the supervisor, who will further inform those in the chain of command.  Incidents 
internal to VA must be reported to the VA-SOC within one hour of the report of the incident.  The incidents 
should be reported to the VA-SOC via the Information Security Officer (ISO) or designee, and entered into the 
Privacy Violation Tracking System (PVTS) by the Privacy Officer.  In turn VA at the department-level will report 
to the US-CERT the information regarding the incident reported to the VA-SOC and in PVTS within the hour 
timeframe.  A distribution list (VHA REPORTS TO US-CERT) has been established for use by the facility ISO 
in reporting all incidents involving personally identifiable information via Exchange, and includes the key VHA 
representatives that need to be notified as well as the VA-SOC Manager and key VA-SOC representatives.   
 
When study personnel are no longer part of the research team, they will be removed from the IRB list of study 
staff and will not have access to data files. 
 
Data will be destroyed at the end of the study in accordance with VA data destruction policies. 
 
 
5. Resources 
 
Research Space 
 
This study will be conducted within the scientific environment and infrastructure of the Translational Research 
Center for TBI and Stress Related Disorders (TRACTS) National Research Center (Boston and Houston 
sites). 
 
Clinical (at VABHS, Boston MA): The following documents our approximately 2200 square feet of laboratory 
space available at the Geriatric Research, Education, and Clinical Center (GRECC) and the Translational 

 
17 
Research Center for TBI and Stress Disorders (TRACTS) at the VA Boston Healthcare System, Jamaica Plain 
Campus, which is the primary location where the work proposed will take place. This space includes behavioral 
and medical testing rooms, computer laboratories, and workrooms. The space currently consists of four testing 
rooms that can be used for individual sessions. One of these testing rooms is connected to an 
office/instrumentation room by a two way mirror to enable observation. Another laboratory room is fully 
equipped for medical examinations and phlebotomy. A conference room is available within the VA Boston 
Healthcare System for use for Group Intervention sessions.  
 
 
Computers: Both Macintosh and PC platforms are available to STEP-Home for word processing, statistical 
analysis, image processing, and bibliography management. A document scanner, inkjet and laser printers, 
photo and slide scanner, video camera, and all necessary software for statistical, graphical and word 
processing are available. The clinical laboratory hosts a local area network with 30 advanced Macintosh and 
Linux based computing systems with peripherals for printing, scanning, faxing and other operations. The 
laboratory hosts an extensive software library to support most aspects of psychological research including task 
design, paradigm presentation, statistical analysis, and MRI data processing. Additional software for 
manuscript preparation includes the Microsoft Office and Adobe Master software suites. The computing 
network is connected via four layer 3 Netgear managed gigabit switches, allowing for rapid access to shared 
network resources that include three servers with dual quad core Intel Xeon processors, 15 TB's of dedicated 
RAID storage, an Exabyte 48 slot tape back up system, and several high volume production level printers.  
 
Offices: TRACTS has office space at the VA Boston Healthcare System, a data processing laboratory for 
research assistants, students, and postdoctoral fellows, as well as the MRI suite that houses the MRI scanner, 
patient/participant waiting room, and additional supportive facilities.  
 
PRIVACY, CONFIDENTIALITY AND INFORMATION SECURITY IN RESEARCH INFORMATION 
 
Q2. All information will be protected in accordance with the VA Boston, and HIPAA regulations. Information 
about subjects or families will not leave the institution in any form that would identify individual subjects or 
families. Data will be transmitted only in pooled form and/or subjects identified by code. All information will be 
kept in locked cabinets accessible only to study staff and on password and security protected network 
computers. Original electronic VA data will be backed up regularly and stored behind the VA firewall. Data will 
be securely transmitted using VA approved methods.  We will use FIPS 140-2 validated encryption. Suspected 
information security and privacy incidents will be reported to the Information Security and Privacy Officers and 
Research Administration.  
 
Q3. All data will be coded and subjects will not be identified by PHI in any publications or presentations. 
 
Q4. Individually identifiable health information is necessary to participate in this study. This information will be 
accessible to the Principal Investigator (PI) and study staff. Participants will not have access to their own 
research related health records. The authorization to use participants’ information will not expire, but 
revocation of authorization is possible. Information collected for the purpose of this research study will be kept 
confidential as required by law. The results of this study may be published for scientific purposes, but individual 
records will not be revealed unless required by law. All information will be protected in accordance with the VA 
Boston, and HIPAA regulations. Information about subjects or families will not leave the institution in any form 
that would identify individual subjects or families. This policy is also detailed in the IRB approved consent form. 
 
Q5-Q15. Please see Authorization for Use and Release of Individually Identifiable Health Information for 
Veterans Health Administration (VHA) Research form (HIPAA Authorization). 
 
Q16-Q20. Please see Application for Waiver of HIPAA Authorization for Research Purposes. 
 
Q21-22. N/A 
 

 
18 
Q24. Software packages including FSL and SPSS will be used in this study and are currently available for 
study use. 
 
Q25. Questionnaires and teleforms may be completed on paper or on an iPad that is non-networked at the 
time of test administration using Qualtrics.  Qualtrics is a platform used to administer surveys/questionnaires by 
organizations and researchers nationwide, including VA medical centers.  The questionnaire and teleform data 
collected by Qualtrics will be coded and not include the patient’s name, social security number, phone, 
address, or DOB.  The key to the code is stored in a separate file behind the VA firewall.  The information 
collected in Qualtrics is temporarily stored by the Qualtrics server and then transferred and stored behind the 
VA firewall. Once given an IRB number, we will establish a specific folder on the secure VA network to store 
the data (i.e. \\VHAVHSNAS21\TRACTS\IRB # 2354). Qualtrics uses very high standards to protect the data. 
Qualtrics has secure transmission services that meet all federal requirements.  Access to data is limited to 
authorized study personnel via login to a secure site.  The original data on the Qualtrics server will be deleted 
after it is transferred to the VA server. 
 
Q26. Data will be collected directly from participants before being securely stored. All information will be kept in 
locked cabinets accessible only to study staff and on password and security protected network computers. 
Relevant data (clinical information) may be imported from databases noted in the protocol. Data will be 
transmitted only in pooled form and/or data will be coded. Data will be securely transmitted using VA approved 
methods. We will use FIPS 140-2 validated encryption.  
 
Q27. Paper forms containing identifiable data are separated from the study data and kept in a locked file 
cabinet in an office that is locked when not occupied. Study staff maintain the only list linking subject identifiers 
to subject numbers. Electronic data are stored on an encrypted password protected server. 
 
Q28. Data will not be stored on a PC hard drive.  
 
Q29. All mobile/portable devices and media will be protected with VA approved FIPS 140-2 compliant 
technology. Laptops are secured in locked offices when not in use. Mobile storage devices will not contain the 
only copy of research information. 
 
Q30. Paper files will be stored in locked areas and cabinets in the TRACTS offices (11th floor C- and D-wings 
(D11-132, D11-89, D11-86, A11-1A, C11-13, C11-13A, C11-11, C11-35), Jamaica Plain Campus, accessible 
only to study staff. Laptops are secured in locked offices when not in use. Electronic data are to be stored on 
the secure research drive of a VA network server. These servers are located on the 3rd floor Server Room (JP 
campus).  
 
Q31. Data will not be removed from the VA protected environment at any time. 
 
Q32. N/A 
 
Q33. Data will be transmitted only in pooled form and/or subjects identified by a code. Data will be securely 
transmitted using VA approved methods. We will use FIPS 140-2 validated encryption.  
 
Q34. Mobile storage devices will not contain the only copy of research information. Original electronic VA data 
will be backed up regularly and stored behind VA firewall.  
 
Q35. In the unlikely scenario that sensitive research data must be shipped off-site, it will be encrypted with 
FIPS 140-2 validated encryption if it is electronic and will be sent via delivery service with a chain of custody.  
 
Q36. N/A 
 
Q37. Data will be kept indefinitely or until the law allows their destruction in accordance with the VA Record 
Control Schedule (www1.va.gov/VHAPUBLICATIONS/RCS10/rcs10-1.pdf). Records will be destroyed, when 
allowed, in the following manner). 

 
19 
• 
Paper records will be shredded   
• 
Electronic records will be destroyed in a manner in which they cannot be retrieved.   
• 
Digital images (photographs, x-rays, scans, video/audio recordings, etc) will be destroyed in a manner 
in which they cannot be retrieved.   
• 
Audio/visual recordings on tape and/or printed photographs will be shredded.   
Q38. Once study team members are no longer a part of the research team, their access to data and research 
materials will be terminated. 
Q39. Suspected information security and privacy incidents will be reported within one hour to the Information 
Security and Privacy Officers and Research Administration. 
STEP-Home Study Protocol – REFERENCES 
 
1. 
Fortier, C.B., et al., Feasibility of a skills-based group reintegration workshop for returning Veterans: 
STEP-Home. Journal of Head Trauma Rehabilitation, In Press. 
2. 
Cantor, J., et al., Evaluation of the short-term executive plus intervention for executive dysfunction after 
traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil, 2014. 
95(1): p. 1-9 e3. 
3. 
Batten, S.V. and S.J. Pollack, Integrative outpatient treatment for returning service members. J Clin 
Psychol, 2008. 64(8): p. 928-39. 
4. 
Hoge, C.W., et al., Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. 
N Engl J Med, 2004. 351(1): p. 13-22. 
5. 
Sayer, N.A., et al., A qualitative study of determinants of PTSD treatment initiation in veterans. 
Psychiatry, 2009. 72(3): p. 238-55. 
6. 
Sayer, N.A., et al., Reintegration problems and treatment interests among Iraq and Afghanistan combat 
veterans receiving VA medical care. Psychiatr Serv, 2010. 61(6): p. 589-97. 
7. 
Sayer, N.A., et al., Iraq and Afghanistan War Veterans with Reintegration Problems: Differences by 
Veterans Affairs Healthcare User Status. Adm Policy Ment Health, 2015. 42(4): p. 493-503. 
8. 
Sayer, N.A., et al., Veterans with history of mild traumatic brain injury and posttraumatic stress disorder: 
challenges from provider perspective. J Rehabil Res Dev, 2009. 46(6): p. 703-16. 
9. 
Gonzalez, O.I., et al., Anger intensification with combat-related PTSD and depression comorbidity. 
Psychol Trauma, 2016. 8(1): p. 9-16. 
10. 
Forbes, D., et al., Mechanisms of anger and treatment outcome in combat veterans with posttraumatic 
stress disorder. J Trauma Stress, 2008. 21(2): p. 142-9. 
11. 
Denneson, L.M., et al., Psychosocial and Healthcare Experiences of OEF/OIF Veterans Before Suicide: 
Qualitative Analysis of VA Medical Records. Military Behavioral Health, 2017. 5(1): p. 1-11. 
12. 
Goetter, E.M., et al., A Systematic Review of Dropout From Psychotherapy for Posttraumatic Stress 
Disorder Among Iraq and Afghanistan Combat Veterans. J Trauma Stress, 2015. 28(5): p. 401-9. 
13. 
Owens, B.D., et al., Combat wounds in operation Iraqi Freedom and operation Enduring Freedom. J 
Trauma, 2008. 64(2): p. 295-9. 
14. 
McCrea, M., et al., Official position of the military TBI task force on the role of neuropsychology and 
rehabilitation psychology in the evaluation, management, and research of military veterans with 
traumatic brain injury. Clin Neuropsychol, 2008. 22(1): p. 10-26. 
15. 
Belanger, H.G., E. Spiegel, and R.D. Vanderploeg, Neuropsychological performance following a history 
of multiple self-reported concussions: a meta-analysis. J Int Neuropsychol Soc, 2010. 16(2): p. 262-7. 
16. 
Belanger, H.G., et al., Factors moderating neuropsychological outcomes following mild traumatic brain 
injury: a meta-analysis. J Int Neuropsychol Soc, 2005. 11(3): p. 215-27. 
17. 
Iverson, G.L., Outcome from mild traumatic brain injury. Curr Opin Psychiatry, 2005. 18(3): p. 301-17. 
18. 
Alexander, M.P., Mild traumatic brain injury: pathophysiology, natural history, and clinical management. 
Neurology, 1995. 45(7): p. 1253-60. 
19. 
Hartlage, L.C., D. Durant-Wilson, and P.C. Patch, Persistent neurobehavioral problems following mild 
traumatic brain injury. Arch Clin Neuropsychol, 2001. 16(6): p. 561-70. 
20. 
Powell, T.J., C. Collin, and K. Sutton, A follow-up study of patients hospitalized after minor head injury. 
Disabil Rehabil, 1996. 18(5): p. 231-7. 

 
20 
21. 
Vanderploeg, R.D., G. Curtiss, and H.G. Belanger, Long-term neuropsychological outcomes following 
mild traumatic brain injury. J Int Neuropsychol Soc, 2005. 11(3): p. 228-36. 
22. 
Leskin, G.A., et al., Adaptation of life care planning to patients with polytrauma in a VA inpatient setting: 
Implications for seamless care coordination. J Rehabil Res Dev, 2007. 44(7): p. xxiii-xxvi. 
23. 
Price, J.L., et al., The role of emotional functioning in military-related PTSD and its treatment. J Anxiety 
Disord, 2006. 20(5): p. 661-74. 
24. 
Hoge, C.W., et al., Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med, 2008. 
358(5): p. 453-63. 
25. 
Schneiderman, A.I., E.R. Braver, and H.K. Kang, Understanding sequelae of injury mechanisms and 
mild traumatic brain injury incurred during the conflicts in Iraq and Afghanistan: persistent 
postconcussive symptoms and posttraumatic stress disorder. Am J Epidemiol, 2008. 167(12): p. 1446-
52. 
26. 
Brenner, L.A., et al., Traumatic brain injury, posttraumatic stress disorder, and postconcussive 
symptom reporting among troops returning from iraq. J Head Trauma Rehabil, 2010. 25(5): p. 307-12. 
27. 
Lew, H.L., et al., Prevalence of chronic pain, posttraumatic stress disorder, and persistent 
postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev, 2009. 
46(6): p. 697-702. 
28. 
Vanderploeg, R.D., H.G. Belanger, and G. Curtiss, Mild traumatic brain injury and posttraumatic stress 
disorder and their associations with health symptoms. Arch Phys Med Rehabil, 2009. 90(7): p. 1084-93. 
29. 
Watts, B.V., et al., Implementation of evidence-based psychotherapies for posttraumatic stress disorder 
in VA specialty clinics. Psychiatr Serv, 2014. 65(5): p. 648-53. 
30. 
Mott, J.M., et al., Characteristics of U.S. veterans who begin and complete prolonged exposure and 
cognitive processing therapy for PTSD. J Trauma Stress, 2014. 27(3): p. 265-73. 
31. 
DeViva, J.C., Treatment utilization among OEF/OIF veterans referred for psychotherapy for PTSD. 
Psychol Serv, 2014. 11(2): p. 179-84. 
32. 
Cooper-Patrick, L., et al., Identification of patient attitudes and preferences regarding treatment of 
depression. J Gen Intern Med, 1997. 12(7): p. 431-8. 
33. 
Schell, T.L. and G.N. Marshall, Survey of individuals previously deployed for OEF/OIF, in Invisible 
Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist 
Recovery, T. Tanielian and J. L.H., Editors. 2008, RAND Corporation: Santa Monica, CA. 
34. 
Facts about Veteran Suicide. VA Suicide Prevention Program. 
35. 
Nelson, H.D., et al., 2015. 
36. 
McGlinchey, R.E., et al. Impact of mTBI on cognition, emotion and the neurobiology of PTSD in 
OEF/OIF Veterans. in Joint Symposium Division 12 & 56 of the American Psychological Associations. 
2012. Washington D.C. 
37. 
Seal, K.H., et al., VA mental health services utilization in Iraq and Afghanistan veterans in the first year 
of receiving new mental health diagnoses. J Trauma Stress, 2010. 23(1): p. 5-16. 
38. 
Zayfert, C., et al., Exposure utilization and completion of cognitive behavioral therapy for PTSD in a 
"real world" clinical practice. J Trauma Stress, 2005. 18(6): p. 637-45. 
39. 
Cooper, D.B., et al. Study of Cognitive Rehabilitation Effectiveness Clinical Trial: Overview 2016; 
Available from: http://dvbic.dcoe.mil/study-manuals. 
40. 
Twamley, E.W., et al., Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for 
veterans with traumatic brain injury: pilot randomized controlled trial. J Rehabil Res Dev, 2014. 51(1): p. 
59-70. 
41. 
Jak, A.J., et al., Evaluation of a hybrid treatment for Veterans with comorbid traumatic brain injury and 
posttraumatic stress disorder: Study protocol for a randomized controlled trial. Contemp Clin Trials, 
2015. 45(Pt B): p. 210-6. 
42. 
Gironda, R.J., et al., Traumatic brain injury, polytrauma, and pain: challenges and treatment strategies 
for the polytrauma rehabilitation. Rehabil Psychol, 2009. 54(3): p. 247-58. 
43. 
Walker, R.L., M.E. Clark, and S.H. Sanders, The post-deployment multi-symptom disorder: an 
emerging syndrome in need of a new treatment paradigm. Psychological Services, 2010. 7(3): p. 136-
147. 
44. 
Borsari, B., et al., Student service members/veterans on campus: Challenges for reintegration. Am J 
Orthopsychiatry, 2017. 87(2): p. 166-175. 

 
21 
45. 
Adler, A.B., et al., Battlemind debriefing and battlemind training as early interventions with soldiers 
returning from iraq: Randomization by platoon. J Consult Clin Psychol, 2009. 77(5): p. 928-40. 
46. 
Cantor, J.B. Executive plus: Preliminary results. in Federal Interagency Conference on Traumatic Brain 
Injury. 2011. Washington, D.C. 
47. 
Gordon, W.A., et al., Traumatic brain injury rehabilitation: state of the science. Am J Phys Med Rehabil, 
2006. 85(4): p. 343-82. 
48. 
Helmick, K., Cognitive rehabilitation for military personnel with mild traumatic brain injury and chronic 
post-concussional disorder: Results of April 2009 consensus conference. NeuroRehabilitation, 2010. 
26(3): p. 239-55. 
49. 
Cantor, J., et al., Evaluation of the STEP intervention for executive dysfunction after traumatic brain 
injury: a randomized controlled trial with minimization. Archives of Physical Medicine and Rehabilitation, 
In Press. 
50. 
Cheyne, J.A., J.S. Carriere, and D. Smilek, Absent-mindedness: Lapses of conscious awareness and 
everyday cognitive failures. Conscious Cogn, 2006. 15(3): p. 578-92. 
51. 
McGlinchey, R.E., et al., A methodology for assessing deployment trauma and its consequences in 
OEF/OIF/OND veterans: The TRACTS longitudinal prospective cohort study. Int J Methods Psychiatr 
Res, 2017. 
52. 
Lippa, S.M., et al., Deployment-related psychiatric and behavioral conditions and their association with 
functional disability in OEF/OIF/OND veterans. J Trauma Stress, 2015. 28(1): p. 25-33. 
53. 
Lippa, S., et al., Polymorbidity: Looking beyond PTSD and TBI in returning service members and 
veterans. Journal of Rehabilitation Research & Development, Submitted. 
54. 
Amick, M.M., et al., The Deployment Trauma Phenotype and Employment Status in Veterans of the 
Wars in Iraq and Afghanistan. J Head Trauma Rehabil, 2017. 
55. 
Resick, P.A., et al., A randomized clinical trial to dismantle components of cognitive processing therapy 
for posttraumatic stress disorder in female victims of interpersonal violence. J Consult Clin Psychol, 
2008. 76(2): p. 243-58. 
56. 
D'Zurilla, T.J. and M.R. Goldfried, Problem solving and behavior modification. J Abnorm Psychol, 1971. 
78(1): p. 107-26. 
57. 
von Cramon, D.Y., Matthes-von Cramon, G., & Mai, N., Problem solving deficits in brain-injured 
patients: a therapeutic approach. Neuropsychological Rehabilitation, 1991. 1: p. 45-64. 
58. 
D'Zurilla, T.J., Problem-solving therapies, in Handbook of Cognitive Behavioral Therapies, K. Dobson, 
Editor. 1988, The Guilford Press: New York, NY. 
59. 
D'Zurilla, T.J.N., A. M., Problem-solving therapies, in Handbook of Cognitive-Behavioral Therapies, 
K.S. Dobson, Editor. 2001, Guilford Press: New York, NY. p. 211-245. 
60. 
Rath, J.F., et al., Group treatment of problem-solving deficits in outpatients with traumatic brain injury: a 
randomised outcome study. Neuropsychological Rehabilitation, 2003. 13(4): p. 461-488. 
61. 
Gordon, W.A., Methodological considerations in cognitive remediation, in Neuropsychological 
Rehabilitation, M. Meier, Diller, L., Benton, A., Editor. 1987, Churchill Livingston: London. p. 111-131. 
62. 
Sohlberg, M.M., et al., APT-II: Attention Processing Training. A program to address attentional deficits 
for persons with mild cognitive dysfunction. 2001, Wake Forest, NC: Lash & Associates 
Publishing/Training Inc. 
63. 
Sohlberg, M.M. and C.A. Mateer, Effectiveness of an attention-training program. J Clin Exp 
Neuropsychol, 1987. 9(2): p. 117-30. 
64. 
D.C., M., et al., The Selection and Design of Control Conditions for Randomized Controlled Trials of 
Psychological Interventions. Psychother Psychosom, 2009. 78: p. 275–284. 
65. 
Schnurr, P.P., et al., Randomized trial of trauma-focused group therapy for posttraumatic stress 
disorder: results from a department of veterans affairs cooperative study. Arch Gen Psychiatry, 2003. 
60(5): p. 481-9. 
66. 
Classen, C., et al., A Comparison of Trauma-Focused and Present-Focused Group Therapy for 
Survivors of Childhood Sexual Abuse: A Randomized Controlled Trial. Psychological Trauma: Theory, 
Research, Practice and Policy, 2011. 3(1): p. 84-93. 
67. 
Classen, C., L.D. Butler, and D. Spiegel, A Treatment manual of present-focused and trauma-focused 
group therapies for sexual abuse survivors at risk for HIV infection, in Department of Psychiatry and 
Behavioral Sciences. 2001, Stanford University School of Medicine: Stanford, CA. 
68. 
Yalom, I.D., Group therapy of incarcerated sexual deviants. J Nerv Ment Dis, 1961. 132: p. 158-70. 

 
22 
69. 
Yalom, I.D., et al., Prediction of improvement in group therapy. An exploratory study. Arch Gen 
Psychiatry, 1967. 17(2): p. 159-68. 
70. 
Bellg, A.J., et al., Enhancing treatment fidelity in health behavior change studies: best practices and 
recommendations from the NIH Behavior Change Consortium. Health Psychol, 2004. 23(5): p. 443-51. 
71. 
Schnurr, P.P., et al., Design of Department of Veterans Affairs Cooperative Study no. 420: group 
treatment of posttraumatic stress disorder. Controlled Clinical Trials. 2001. 22(1): p. 74-88. 
72. 
Bauer, M.S., et al., An introduction to implementation science for the non-specialist. BMC Psychol, 
2015. 3: p. 32. 
73. 
Kenny, D.A., Cross-lagged panel correlation: A test for spuriousness. Psych Bull, 1975. 82: p. 887-903. 
74. 
Katz L. S., Cojucar G., Davenport C. Y., Pedram C., Lindl C. Post-deployment readjustment inventory: 
Reliability, validity, and gender differences. Mil. Psychol, 2010. 22, 41–56. 
75. 
Spielberger, C. D. Manual for the State-Trait Anger Expression Inventory–2. Odessa, FL: Psychological 
Assessment Resources, 1999. 
76.  
Sayer, N.A. et al., Military to civilian questionnaire: a measure of postdeployment community 
reintegration difficulty among veterans using Department of Veterans Affairs medical care. J Trauma 
Stress, 2011, 24, 660-70. 
77. 
Heppner, P. and C. Petersen, The development and implications of a personal problem-solving 
inventory. J Counsel Psychol, 1982. 29: p. 66-75. 
78. 
Tull, M.T., et al., A preliminary investigation of the relationship between emotion regulation difficulties 
and posttraumatic stress symptoms. Behav Ther, 2007. 38(3): p. 303-13. 
79. 
Neumann, D., J.F. Malec, and F.M. Hammond, Reductions in Alexithymia and Emotion Dysregulation 
After Training Emotional Self-Awareness Following Traumatic Brain Injury: A Phase I Trial. J Head 
Trauma Rehabil, 2017. 
80.  
Ritschel, L.A., et al., Psychometric properties of the Difficulties in Emotion Regulation Scale across 
demographic groups. Psychol Assess, 2015. 27(3): p. 944-54. 
81. 
Gratz, K.L. and L. Roemer, Multidimensional assessment of emotion regulation and dysregulation: 
development, factor structure, and initial validation of the difficulties in emotion regulation scale. J 
Psychopathol Behav Assess, 2004. 26(1): p. 41-54. 
82. 
Bovin, M.J., et al., Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual 
of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess, 2016. 28(11): p. 1379-1391. 
83.  
Henry, J. D., & Crawford, J. R. The short-form version of the Depression Anxiety Stress Scales (DASS-
21): Construct validity and normative data in a large non-clinical sample. British Journal of Clinical 
Psychology, 2005. 44, 227–239. 
84. 
Soble, J.R., et al. Normative Data for the Neurobehavioral Symptom Inventory (NSI) and Post-
Concussion Symptom Profiles Among TBI, PTSD, and Nonclinical Samples. The Clinical 
Neuropsychologist, 2014. 28: 614-616. 
85. 
Ustun, T.B., et al., Developing the World Health Organization Disability Assessment Schedule 2.0. Bull 
World Health Organ, 2010. 88(11): 815-23. 
86.  
Diener, E., Emmons, R. A., Larsen, R. J., & Griffin, S. The Satisfaction with Life. Scale. Journal of 
Personality Assessment, 1985. 49: 71-75. 
87. 
Liptak, J.J., Barriers to employment success inventory: administrators' guide. 4th ed. ed. 2011, 
Indianapolis, IN: JIST Publishing. 
88. 
Valeri, L., & VanderWeele, T. J. Mediation analysis allowing for exposure–mediator interactions and 
causal interpretation: Theoretical assumptions and implementation with SAS and SPSS macros. 
Psychological methods, 2013. 18(2): 137. 
89. 
Hsieh, F. Y. Sample size formulae for intervention studies with the cluster as unit of 
randomization. Statistics in medicine, 1988. 7(11): 1195-1201.