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

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ClinicalTrials.gov Identifier: NCT03868930
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 7, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Military to Civilian Questionnaire (Change) [ Time Frame: Screening, 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 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)
  • Post-deployment Readjustment Inventory (Change) [ Time Frame: Screening, 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. 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) [ Time Frame: Screening, 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 (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
  • Problem Solving Inventory (PSI) (Change) [ Time Frame: Screening, 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. 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) [ Time Frame: Screening, 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
  • Attention-Related Cognitive Errors Scale (ARCES) (Change) [ Time Frame: Screening, 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03868930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • PTSD Checklist for DSM-5 (PCL-5) (Change) [ Time Frame: 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) [ Time Frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) ]
    A 21-item measure of current depression, anxiety, and stress. Min: 21, Max: 84 (lower scores are better)
  • Neurobehavioral Symptoms Inventory (NSI) (Change) [ Time Frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) ]
    A 22-item measure of current post-concussive symptoms. Min: 0, Max: 88 (lower scores are better)
  • World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) [ Time Frame: 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). Min and max scores are below. Lower scores are better. Work-School: Min: 0, Max: 16 Total Aggregate: Min: 0, Max: 128
  • Satisfaction with Life Scale (SWLS) (Change) [ Time Frame: 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)
  • Treatment/Activities Survey (Change) [ Time Frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) ]
    Assesses engagement in treatment, school, work, and life activities. A scale is not used in this measure.
  • Barriers to Employment Success Inventory (BESI) (Change) [ Time Frame: 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. 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
  • Average number of hours worked (Change) [ Time Frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) ]
    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.
  • Frontal Systems Behavior Scale (FrSBe) (Change) [ Time Frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
Official Title  ICMJE Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to one of the two group interventions: STEP-Home or Present Centered Group Therapy (PCGT). Each cohort will include a minimum of 8 and a maximum of 20 participants who will be randomized to either STEP-Home (n = 4-10 Veterans) or PCGT (n = 4-10 Veterans). After inclusion and exclusion criteria are verified and a cohort of 8 to 20 is available, randomization into STEP-Home or PCGT occurs and participation in the study begins (i.e., Time 1; T1: Pre), during which the investigators will consent, administer the baseline assessments, randomly assign to the STEP-Home or PCGT arm, and schedule the treatment sessions. All participants will be assessed at the following outcome points: Screening, at randomization (T1), during treatment 4-week skills check (T2), during treatment 8-week skills check (T3), post-intervention (T4), and at 3-months follow up (T5).
Masking: Single (Participant)
Masking Description:
Assessments are all self-report, therefore, blinded assessors are not required.
Primary Purpose: Treatment
Condition  ICMJE
  • Post-traumatic Stress Disorder
  • Traumatic Brain Injury
  • Substance Related Disorders
  • Depression
  • Anxiety Disorders
  • Suicide
  • Pain
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: STEP-Home
    The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
    Intervention: Behavioral: STEP-Home
  • Active Comparator: PCGT
    The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
    Intervention: Behavioral: PCGT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2019)
208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 18-65 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Catherine B Fortier, PhD (857) 364-4361 catherine.fortier@va.gov
Contact: Colleen Hursh (857) 364-2093 Colleen.Hursh@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03868930
Other Study ID Numbers  ICMJE D2907-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine B Fortier, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
PRS Account VA Office of Research and Development
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP