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

Not Applicable

Completed

Conditions: Anxiety Disorders
Suicide
Traumatic Brain Injury
Substance Related Disorders
Post-traumatic Stress Disorder
Depression
Pain

Interventions: Behavioral: PCGT
Behavioral: STEP-Home

Registration Number: NCT03868930

Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 221

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Military to Civilian Questionnaire	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	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
Post-deployment Readjustment Inventory (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	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. Total score is calculated by adding the value of all items in all subscales. 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
State-Trait Anger Expression Inventory (STAXI-2) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better. How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items)

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Life Scale (SWLS) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	A 5-item measure of satisfaction with life. Min: 5, Max: 35 (higher scores are better)
Attention-Related Cognitive Errors Scale (ARCES) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	Measure of everyday performance failures arising from brief failures of sustained attention. Min: 12, Max: 60 (lower scores are better)
Problem Solving Inventory (PSI) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	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. Total score calculated by adding the scores of all items. 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
Difficulties in Emotion Regulation Scale (DERS) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	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, Total score calculated by adding the scores of all items (reverse scoring awareness items).
PTSD Checklist for DSM-5 (PCL-5) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	A 20-item measure of PTSD updated for DSM-5. Min: 0, Max: 80 (lower scores are better)
Depression Anxiety and Stress Scale (DASS-21) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	A 21-item measure of current depression, anxiety, and stress. Each subscale Min: 7, Max: 28 (lower scores are better)
Neurobehavioral Symptoms Inventory (NSI) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	A 22-item measure of current post-concussive symptoms. Total score Min: 0, Max: 88 (lower scores are better), calculated by adding the scores of all of the subscales. Vestibular Min: 0, Max: 12 (3 items) Somatosensory Min: 0, Max: 20 (5 items) Affective Min: 0, Max: 24 (6 items) Cognitive Min: 0, Max: 32 (8 items)
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	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). Possible raw min and max scores are below. For all subscales and total score, data is presented as a computed score in a range from 0-100. This is calculated by taking the raw score for each subscale and total score, dividing it by number of possible points for the relevant questions, and multiplying it by 100. Lower scores are better. Understanding and Communicating: Min: 0, Max: 24 Getting Around: Min: 0, Max: 20 Self Care: Min: 0, Max: 16 Getting Along with People: Min: 0, Max: 20 Life Activities: Min: 0, Max: 16 Work-School: Min: 0, Max: 16 Participation: Min: 0, Max: 32 Total Aggregate: Min: 0, Max: 144
Number of Participants Differing in Activity Engagement Over Time (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	Assesses engagement in school, work, and life activities. Participants self reported engagement in each category at each time point. Categories are not mutually exclusive, but rather indicate how many participants endorsed participating in each category at each time point. A scale is not used in this measure.
Barriers to Employment Success Inventory (BESI) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	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. Only total score analyzed, subscales not reported. 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
Number of Participants Differing in Average Number of Hours Worked (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	Change in average number of hours worked per month over time. Participants self-reported average number of hours worked in the month before STEP-Home (baseline), in each month of the intervention/PCGT (measured at post-treatment), and post-treatment monitoring (follow-up). A scale is not used in this measure. Each row indicates the number of participants that worked the indicated number of hours at each time point. Rows are mutually exclusive.
Frontal Systems Behavior Scale (FrSBe) (Change)	Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)	Measures apathy, disinhibition, and executive dysfunction. Min and max possible scores for subscales and total score are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Subscale scores calculated by adding the scores of the items in each subscale. Apathy Min: 14, Max: 70 Disinhibition Min: 15, Max: 75 Executive Dysfunction Min: 17, Max: 85 Total Score Min: 46, Max: 230

Trial Locations

Locations (2): VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Boston, Massachusetts, United States
Michael E. DeBakey VA Medical Center, Houston, TX
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Houston, Texas, United States