Post-traumatic Stress DisorderSTEP-HomeNCT03868930
Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
A study testing STEP-Home and PCGT in people with Post-traumatic Stress Disorder and Traumatic Brain Injury, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
In this proposal, the investigators extend their 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Traumatic Brain Injury, Substance Related Disorders
- What is being tested?
- STEP-Home and PCGT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2019to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 18-75 years old (to avoid outcomes being affected by aging)
- English-speaking (sessions will be conducted in English)
- Agreeing to participate
- i.e., completion of ICF/HIPAA
Who cannot join
- schizophreniform disorder/active psychosis
- bipolar disorder
- active suicidality/homicidality requiring crisis intervention
- other severe psychiatric disorders prohibiting appropriate group participation
- neurological diagnosis prohibiting appropriate group participation (excluding TBI)
- current substance dependence
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
In this proposal, the investigators extend their 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 the investigators' 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, 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.
The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the 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.
Read the detailed description
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. 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. High rates of marital, family, and cohabitation discord were reported, with 75% reporting a family conflict in the last week. 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. Research has shown that anger directly influences treatment outcome. 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. Veterans with probable PTSD report more reintegration and anger problems, and greater interest in services than Veterans without. Reintegration and anger problems continue for years post-combat and may not resolve without intervention.
Research on TBI in post-9/11 Veterans 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. 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).
Phase 1: Years 1 and 2 The investigators 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 and 4 The investigators will initiate the study at the second site, the Houston VAMC, in Year 3. The investigators will apply in Year 2 for IRB approval to initiate site 2.
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 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 Hypothesis 1. 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.
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.
- Conditions
- Post-traumatic Stress Disorder, Traumatic Brain Injury, Substance Related Disorders, Depression, Anxiety Disorders, Suicide
- Being tested
- STEP-Home, PCGT
- Keywords
- Mental health, Veterans health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Substance-Related Disorders, Depression, Anxiety Disorders, Suicide, Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEP-HomeBehavioural
This group will meet for 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.
PCGTBehavioural
The PCGT group will also meet for 2 hours a week for 12 weeks. 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). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
| Study group | Role | What they receive |
|---|---|---|
| STEP-Home | Experimental | The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies. Receives: Behavioral: STEP-Home |
| PCGT | Active comparator | The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors. Receives: Behavioral: PCGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Military to Civilian Questionnaire
A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties.
Min: 0, Max: 64
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Post-deployment Readjustment Inventory (Change)
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). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score is calculated by adding the value of all items in all subscales.
Career: Min: 5, Max: 25 Health: Min: 5, Max: 25 Intimate Relationship: Min: 5, Max: 25 Social readjustment: Min: 7, Max: 35 Concerns about deployment: Min: 6, Max: 30 PTSD symptoms: Min: 8, Max: 40 TOTAL score: Min: 36, Max: 180
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
State-Trait Anger Expression Inventory (STAXI-2) (Change)
A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better.
How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items)
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Secondary outcomes (12)
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Measure of everyday performance failures arising from brief failures of sustained attention.
Min: 12, Max: 60 (lower scores are better)
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Problem Solving Inventory (PSI) (Change)
Measure of problem solving confidence, approach-avoidance style, and personal control. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score calculated by adding the scores of all items.
Problem-Solving Confidence: Min: 11, Max: 66 Approach-Avoidance Style: Min: 16, Max: 96 Personal Control: Min: 5, Max: 30 TOTAL score: Min: 32, Max: 192
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Difficulties in Emotion Regulation Scale (DERS) (Change)
Measure to assess multiple aspects of emotion dysregulation. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better.
Nonacceptance of emotional responses: Min: 6, Max: 30 Difficulty engaging in goal-directed behavior: Min: 6, Max: 25 Impulse control difficulties: Min: 6, Max: 30 Lack of emotional awareness: Min: 6, Max: 30 Limited access to emotion regulation strategies: Min: 8, Max: 40 Lack of emotional clarity: Min: 5, Max: 25 TOTAL score: Min: 36, Max: 180, Total score calculated by adding the scores of all items (reverse scoring awareness items).
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
PTSD Checklist for DSM-5 (PCL-5) (Change)
A 20-item measure of PTSD updated for DSM-5. Min: 0, Max: 80 (lower scores are better)
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Depression Anxiety and Stress Scale (DASS-21) (Change)
A 21-item measure of current depression, anxiety, and stress. Each subscale Min: 7, Max: 28 (lower scores are better)
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Neurobehavioral Symptoms Inventory (NSI) (Change)
A 22-item measure of current post-concussive symptoms. Total score Min: 0, Max: 88 (lower scores are better), calculated by adding the scores of all of the subscales.
Vestibular Min: 0, Max: 12 (3 items) Somatosensory Min: 0, Max: 20 (5 items) Affective Min: 0, Max: 24 (6 items) Cognitive Min: 0, Max: 32 (8 items)
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
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). Possible raw min and max scores are below. For all subscales and total score, data is presented as a computed score in a range from 0-100. This is calculated by taking the raw score for each subscale and total score, dividing it by number of possible points for the relevant questions, and multiplying it by 100. Lower scores are better.
Understanding and Communicating: Min: 0, Max: 24 Getting Around: Min: 0, Max: 20 Self Care: Min: 0, Max: 16 Getting Along with People: Min: 0, Max: 20 Life Activities: Min: 0, Max: 16 Work-School: Min: 0, Max: 16 Participation: Min: 0, Max: 32 Total Aggregate: Min: 0, Max: 144
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Satisfaction With Life Scale (SWLS) (Change)
A 5-item measure of satisfaction with life. Min: 5, Max: 35 (higher scores are better)
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Number of Participants Differing in Activity Engagement Over Time (Change)
Assesses engagement in school, work, and life activities. Participants self reported engagement in each category at each time point. Categories are not mutually exclusive, but rather indicate how many participants endorsed participating in each category at each time point.
A scale is not used in this measure.
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Barriers to Employment Success Inventory (BESI) (Change)
A measure of obstacles to employment in five areas (Personal/Financial, Emotional/Physical, Career Decision-Making and Planning, Job-Seeking Knowledge, and Training/Education). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Only total score analyzed, subscales not reported.
Personal and Financial: Min: 10, Max: 40 Emotional and Physical: Min: 10, Max: 40 Career Decision-Making and Planning: Min: 10, Max: 40 Job-Seeking Knowledge: Min: 10, Max: 40 Training and Education: Min: 10, Max: 40 TOTAL score: Min: 50, Max: 200
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Number of Participants Differing in Average Number of Hours Worked (Change)
Change in average number of hours worked per month over time. Participants self-reported average number of hours worked in the month before STEP-Home (baseline), in each month of the intervention/PCGT (measured at post-treatment), and post-treatment monitoring (follow-up).
A scale is not used in this measure. Each row indicates the number of participants that worked the indicated number of hours at each time point. Rows are mutually exclusive.
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Frontal Systems Behavior Scale (FrSBe) (Change)
Measures apathy, disinhibition, and executive dysfunction. Min and max possible scores for subscales and total score are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Subscale scores calculated by adding the scores of the items in each subscale.
Apathy Min: 14, Max: 70 Disinhibition Min: 15, Max: 75 Executive Dysfunction Min: 17, Max: 85 Total Score Min: 46, Max: 230
Measured: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start17 Jun 2019
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two group interventions: STEP-Home or Present Centered Group Therapy (PCGT). 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) or PCGT (n = 4-10 Veterans). After inclusion and exclusion criteria are verified and a cohort of 8 to 20 is available, randomization into STEP-Home or PCGT occurs and participation in the study begins (i.e., Time 1; T1: Pre), during which the investigators will consent, administer the baseline assessments, randomly assign to the STEP-Home or PCGT arm, and schedule the treatment sessions. All participants will be assessed at the following outcome points: Screening, at randomization (T1), during treatment 4-week skills check (T2), during treatment 8-week skills check (T3), post-intervention (T4), and at 3-months follow up (T5).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Catherine B Fortier, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868930
- Sponsor's protocol ID
- D2907-R
- Acronym
- STEP-Home
- Status last verified
- Oct 2025
- First submitted
- 7 Mar 2019
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fortier CB, Currao A, Kenna A, Kim S, Beck BM, Katz D, Hursh C, Fonda JR. Online Telehealth Delivery of Group Mental Health Treatment Is Safe, Feasible, and Increases Enrollment and Attendance in Post-9/11 U.S. Veterans. Behav Ther. 2022 May;53(3):469-480. doi: 10.1016/j.beth.2021.11.004. Epub 2021 Nov 25.
PubMed 35473650Fortier CB, Kenna A, Katz D, Kim S, Hursh C, Beck B, Sablone CA, Currao A, Lebas A, Jorge RE, Fonda JR. STEP-Home transdiagnostic group reintegration workshop to improve mental health outcomes for post-9/11 Veterans: Design, methods, and rationale for a randomized controlled behavioral trial. Contemp Clin Trials. 2024 Jun;141:107536. doi: 10.1016/j.cct.2024.107536. Epub 2024 Apr 16.
PubMed 38614448
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
- ClinicalTrials.gov ID
- NCT03868930
- Acronym / sponsor ID
- STEP-Home / D2907-R
- Conditions
- Post-traumatic Stress Disorder, Traumatic Brain Injury, Substance Related Disorders, Depression, Anxiety Disorders, Suicide
- Keywords
- Mental health, Veterans health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this proposal, the investigators extend their 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 the investigators' 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, 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.
The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the 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.
Detailed description
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. 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. High rates of marital, family, and cohabitation discord were reported, with 75% reporting a family conflict in the last week. 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. Research has shown that anger directly influences treatment outcome. 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. Veterans with probable PTSD report more reintegration and anger problems, and greater interest in services than Veterans without. Reintegration and anger problems continue for years post-combat and may not resolve without intervention.
Research on TBI in post-9/11 Veterans 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. 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).
Phase 1: Years 1 and 2 The investigators 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 and 4 The investigators will initiate the study at the second site, the Houston VAMC, in Year 3. The investigators will apply in Year 2 for IRB approval to initiate site 2.
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 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 Hypothesis 1. 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two group interventions: STEP-Home or Present Centered Group Therapy (PCGT). 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) or PCGT (n = 4-10 Veterans). After inclusion and exclusion criteria are verified and a cohort of 8 to 20 is available, randomization into STEP-Home or PCGT occurs and participation in the study begins (i.e., Time 1; T1: Pre), during which the investigators will consent, administer the baseline assessments, randomly assign to the STEP-Home or PCGT arm, and schedule the treatment sessions. All participants will be assessed at the following outcome points: Screening, at randomization (T1), during treatment 4-week skills check (T2), during treatment 8-week skills check (T3), post-intervention (T4), and at 3-months follow up (T5).
| Arm | Type | Receives |
|---|---|---|
| STEP-Home | Experimental | Behavioral: STEP-HomeThe STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies. |
| PCGT | Active comparator | Behavioral: PCGTThe Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post-9/11 Veterans who report some reintegration, readjustment, or anger difficulty
- 18-75 years old (to avoid outcomes being affected by aging)
- English-speaking (sessions will be conducted in English)
- Agreeing to participate
Key exclusion criteria (8 listed)
- schizophreniform disorder/active psychosis
- bipolar disorder
- active suicidality/homicidality requiring crisis intervention
- other severe psychiatric disorders prohibiting appropriate group participation
- neurological diagnosis prohibiting appropriate group participation (excluding TBI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEP-HomeThis group will meet for 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. | Behavioural | STEP-Home |
| PCGTThe PCGT group will also meet for 2 hours a week for 12 weeks. 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). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health. | Behavioural | PCGT |
Primary outcome
Military to Civilian Questionnaire
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties. Min: 0, Max: 64
Post-deployment Readjustment Inventory (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
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). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score is calculated by adding the value of all items in all subscales. Career: Min: 5, Max: 25 Health: Min: 5, Max: 25 Intimate Relationship: Min: 5, Max: 25 Social readjustment: Min: 7, Max: 35 Concerns about deployment: Min: 6, Max: 30 PTSD symptoms: Min: 8, Max: 40 TOTAL score: Min: 36, Max: 180
State-Trait Anger Expression Inventory (STAXI-2) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better. How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items)
12 secondary outcomes
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Problem Solving Inventory (PSI) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Difficulties in Emotion Regulation Scale (DERS) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
PTSD Checklist for DSM-5 (PCL-5) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Depression Anxiety and Stress Scale (DASS-21) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Neurobehavioral Symptoms Inventory (NSI) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Satisfaction With Life Scale (SWLS) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Number of Participants Differing in Activity Engagement Over Time (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Barriers to Employment Success Inventory (BESI) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Number of Participants Differing in Average Number of Hours Worked (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Frontal Systems Behavior Scale (FrSBe) (Change)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35473650Fortier CB, Currao A, Kenna A, Kim S, Beck BM, Katz D, Hursh C, Fonda JR. Online Telehealth Delivery of Group Mental Health Treatment Is Safe, Feasible, and Increases Enrollment and Attendance in Post-9/11 U.S. Veterans. Behav Ther. 2022 May;53(3):469-480. doi: 10.1016/j.beth.2021.11.004. Epub 2021 Nov 25.
- Background: PubMed 38614448Fortier CB, Kenna A, Katz D, Kim S, Hursh C, Beck B, Sablone CA, Currao A, Lebas A, Jorge RE, Fonda JR. STEP-Home transdiagnostic group reintegration workshop to improve mental health outcomes for post-9/11 Veterans: Design, methods, and rationale for a randomized controlled behavioral trial. Contemp Clin Trials. 2024 Jun;141:107536. doi: 10.1016/j.cct.2024.107536. Epub 2024 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine B Fortier, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEP-Home and PCGT in people with Post-traumatic Stress Disorder and Traumatic Brain Injury, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Military to Civilian Questionnaire (time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03868930, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.