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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 : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Traumatic Brain Injury Substance Related Disorders Depression Anxiety Disorders Suicide Pain Behavioral: STEP-Home Behavioral: PCGT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
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
Official Title: Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: STEP-Home
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
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.

Active Comparator: PCGT
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
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.




Primary Outcome Measures :
  1. 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)


  2. 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


  3. 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


  4. 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


  5. 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


  6. 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)



Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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


  5. 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)

  6. 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.

  7. 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


  8. 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.


  9. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868930


Contacts
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Contact: Catherine B Fortier, PhD (857) 364-4361 catherine.fortier@va.gov
Contact: Colleen Hursh (857) 364-2093 Colleen.Hursh@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Maria Higgins    857-364-4802    maria.higgins@va.gov   
Contact: Nickey Ortega    (857) 364-5669    Niquel.Ortega@va.gov   
Principal Investigator: Catherine B Fortier, PhD         
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Not yet recruiting
Houston, Texas, United States, 77030
Contact: Ricardo Jorge, MD       Ricardo.Jorge@bcm.edu   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Catherine B Fortier, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03868930     History of Changes
Other Study ID Numbers: D2907-R
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Mental health
Veterans health

Additional relevant MeSH terms:
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Disease
Brain Injuries
Brain Injuries, Traumatic
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Suicide
Substance-Related Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Mental Disorders
Trauma and Stressor Related Disorders
Self-Injurious Behavior
Behavioral Symptoms
Chemically-Induced Disorders