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NCT03868930 · ClinicalTrials.gov registry record · NA
Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 221
- Enrollment target
NCT03868930: Completed NA study, sponsored by VA Office of Research and Development.
NCT03868930 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 221 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03868930, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 221 participants
- Enrollment target
Study 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 healt
Primary Outcome
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
Interventions
- BEHAVIORAL STEP-Home
- BEHAVIORAL PCGT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2024-03-29 |
| Phase | NA |
What the finished NCT03868930 record still lists
NCT03868930 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which STEP-Home is the first listed.
NCT03868930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03868930 about?
NCT03868930 is a clinical study titled "Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop". 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 ...
What is the current status of trial NCT03868930?
This trial is currently completed. It is a NA study. The enrollment target is 221 participants. The study started on 2019-06-17. Estimated completion is 2024-03-29.
What interventions are being tested in trial NCT03868930?
The interventions under investigation include: STEP-Home (BEHAVIORAL), PCGT (BEHAVIORAL).
Who is sponsoring clinical trial NCT03868930?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03868930's enrollment target sits among peer trials
221 481st of 2000 higher than 1,520 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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