Depression Clinical Trial
— STEP-HomeOfficial title:
Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
NCT number | NCT03868930 |
Other study ID # | D2907-R |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 17, 2019 |
Est. completion date | March 29, 2024 |
Verified date | April 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 221 |
Est. completion date | March 29, 2024 |
Est. primary completion date | March 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Military to Civilian Questionnaire (Change) | A 16-item measure of post-deployment community reintegration in post-9/11 Veterans that assesses six domains (interpersonal relationships, productivity at work, school or home, community participation, self-care, leisure, and perceived meaning of life).
Min: 0, Max: 64 (lower scores are better) |
Screening, Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Primary | 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.
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 |
Screening, Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Primary | 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 (trait anger, anger expression, and anger control). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better.
How I Feel Right Now: Min: 10, Max: 40 How I Generally Feel: Min: 10, Max: 40 When Angry or Furious: Min: 24, Max: 96 TOTAL score: Min: 44, Max: 176 |
Screening, Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Primary | 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.
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 |
Screening, Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Primary | 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 |
Screening, Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Primary | 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) |
Screening, Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | 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) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | Depression Anxiety and Stress Scale (DASS-21) (Change) | A 21-item measure of current depression, anxiety, and stress. Min: 21, Max: 84 (lower scores are better) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | Neurobehavioral Symptoms Inventory (NSI) (Change) | A 22-item measure of current post-concussive symptoms. Min: 0, Max: 88 (lower scores are better) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | 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). Min and max scores are below. Lower scores are better.
Work-School: Min: 0, Max: 16 Total Aggregate: Min: 0, Max: 128 |
Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | Satisfaction with Life Scale (SWLS) (Change) | A 5-item measure of satisfaction with life. Min: 5, Max: 35 (higher scores are better) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | Treatment/Activities Survey (Change) | Assesses engagement in treatment, school, work, and life activities. A scale is not used in this measure. | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | 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.
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 |
Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | Average number of hours worked (Change) | Number of hours per month in the month before STEP-Home and in each month of the intervention/PCGT, and post-treatment monitoring.
A scale is not used in this measure. |
Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | |
Secondary | Frontal Systems Behavior Scale (FrSBe) (Change) | Measures apathy, disinhibition, and executive dysfunction. Min and max scores for the subscales are below. For all, lower scores are better.
Before deployment: Min: 46, Max: 230 At the present time: Min: 46, Max: 230 |
Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) |
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