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

NCT03868930 | Completed Results DMC

• 1 other identifier: D2907-R
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Mental health; Veterans health

Outcome Measures

Primary Outcomes (3)

• Military to Civilian Questionnaire

  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

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

• 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. 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

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

• 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 (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)

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

Secondary Outcomes (12)

• Attention-Related Cognitive Errors Scale (ARCES) (Change)

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

• Problem Solving Inventory (PSI) (Change)

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

• Difficulties in Emotion Regulation Scale (DERS) (Change)

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

• PTSD Checklist for DSM-5 (PCL-5) (Change)

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

• Depression Anxiety and Stress Scale (DASS-21) (Change)

  Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)

Study Arms (2)

STEP-Home

EXPERIMENTAL

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

Behavioral: STEP-Home

PCGT

ACTIVE COMPARATOR

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

Behavioral: PCGT

Interventions

STEP-Home BEHAVIORAL

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.

STEP-Home

PCGT BEHAVIORAL

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.

PCGT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 35473650 BACKGROUND

• Fortier CB, Kenna A, Katz D, Kim S, Hursh C, Beck B, Sablone CA, Currao A, Lebas A, Jorge RE, Fonda JR. STEP-Home transdiagnostic group reintegration workshop to improve mental health outcomes for post-9/11 Veterans: Design, methods, and rationale for a randomized controlled behavioral trial. Contemp Clin Trials. 2024 Jun;141:107536. doi: 10.1016/j.cct.2024.107536. Epub 2024 Apr 16.

  PMID: 38614448 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Substance-Related Disorders; Depression; Anxiety Disorders; Suicide; Pain; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Chemically-Induced Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Limitations and Caveats

The study sample is predominantly male and white, so results should not be generalized to other populations. Treatment outcomes were based on participant self-report. Low follow-up assessment rates were observed due to challenges retaining randomized participants who did not initiate treatment or dropped out of treatment over time, as well as lack of completion of assessments by treatment completers (although completion rates are within expectation for the post-9/11 population of Veterans).

Results Point of Contact

• Title: Dr. Catherine B. Fortier
• Organization: VA Boston Healthcare System

Catherine.Fortier@va.gov

857-364-4361

Study Officials

• Catherine B Fortier, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Assessments are all self-report, therefore, blinded assessors are not required.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: June 17, 2019
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: October 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)