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

Depression Clinical Trial

— STEP-Home  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868930
• Other study ID #: D2907-R
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: March 29, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Brain Injuries
• Brain Injuries, Traumatic
• Depression
• Pain
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Related Disorders
• Substance-Related Disorders
• Suicide
• Traumatic Brain Injury

Intervention

Behavioral:
• STEP-Home
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
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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)