Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT03868930
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • STEP-Home — BEHAVIORAL
    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.
  • PCGT — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Jun 17, 2019
Status verified
Oct 2025
Primary completion
Mar 29, 2024
Completion
Mar 29, 2024

Study Design

Enrollment
221 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: STEP-Home
    The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
  • Active Comparator: PCGT
    The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.

Primary Outcome Measure

Military to Civilian Questionnaire [ Time Frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) ]

Locations (2)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817-
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-

Find similar trials in Boston, MA

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MAMichael E. DeBakey VA Medical Center, Houston, TX· Houston, TX

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