N/A
Completed N=195
Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
Source: ClinicalTrials.gov NCT03868930 ↗Enrolled (actual)
195
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Military to Civilian Questionnaire — 33.8; 34.7; 25.5; 27.1 score on a scale — p=<.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Military to Civilian Questionnaire |
33.8; 34.7; 25.5; 27.1; 24.4; 27.7 | <.0001 sig |
| PRIMARY Post-deployment Readjustment Inventory (Change) |
117.1; 121.0; 107.8; 116.2; 100.0; 111.1 | 0.0044 sig |
| PRIMARY State-Trait Anger Expression Inventory (STAXI-2) (Change) |
25.8; 26.2; 21.9; 21.6; 43.1; 42.0 | 0.0140 sig |
| SECONDARY Attention-Related Cognitive Errors Scale (ARCES) (Change) |
41.9; 42.7; 38.2; 39.6; 37.7; 39.0 | — |
| SECONDARY Problem Solving Inventory (PSI) (Change) |
100.6; 102.6; 93.1; 94.1; 94.3; 95.3 | — |
| SECONDARY Difficulties in Emotion Regulation Scale (DERS) (Change) |
104.2; 106.9; 90.8; 97.6; 89.2; 94.0 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) (Change) |
43.5; 44.9; 36.3; 39.6; 34.9; 41.0 | — |
| SECONDARY Depression Anxiety and Stress Scale (DASS-21) (Change) |
15.4; 14.6; 18.7; 19.0; 20.7; 20.9 | — |
| SECONDARY Neurobehavioral Symptoms Inventory (NSI) (Change) |
39.2; 39.0; 30.5; 35.0; 27.9; 36.3 | — |
| SECONDARY World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) |
39.2; 38.3; 31.6; 33.5; 31.0; 33.7 | — |
| SECONDARY Satisfaction With Life Scale (SWLS) (Change) |
15.1; 15.3; 18.0; 16.6; 17.8; 17.7 | — |
| SECONDARY Number of Participants Differing in Activity Engagement Over Time (Change) |
42; 37; 18; 26; 15; 19 | — |
| SECONDARY Barriers to Employment Success Inventory (BESI) (Change) |
103.5; 101.8; 90.7; 96.3; 89.0; 88.3 | — |
| SECONDARY Number of Participants Differing in Average Number of Hours Worked (Change) |
53; 55; 4; 4; 3; 6 | — |
| SECONDARY Frontal Systems Behavior Scale (FrSBe) (Change) |
124.8; 124.9; 111.8; 111.9; 109.2; 110.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03868930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.