Clinical trial NCT03868930: Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
Official title: Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Traumatic Brain Injury
Substance Related Disorders
Depression
Anxiety Disorders
Suicide
Pain
Keywords: Mental health
Veterans health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-03-11
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Military to Civilian Questionnaire
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Post-deployment Readjustment Inventory (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: State-Trait Anger Expression Inventory (STAXI-2) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Secondary outcomes:
measure: Attention-Related Cognitive Errors Scale (ARCES) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Problem Solving Inventory (PSI) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Difficulties in Emotion Regulation Scale (DERS) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: PTSD Checklist for DSM-5 (PCL-5) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Depression Anxiety and Stress Scale (DASS-21) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Neurobehavioral Symptoms Inventory (NSI) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Satisfaction With Life Scale (SWLS) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Number of Participants Differing in Activity Engagement Over Time (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Barriers to Employment Success Inventory (BESI) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Number of Participants Differing in Average Number of Hours Worked (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
measure: Frontal Systems Behavior Scale (FrSBe) (Change)
timeFrame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Catherine B Fortier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fortier 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.