Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
208

Summary

Conditions
  • Anxiety Disorders
  • Depression
  • Pain
  • Post Traumatic Stress Disorder
  • Substance Related Disorders
  • Suicide
  • Traumatic Brain Injury
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 Vet...

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.

Tracking Information

NCT #
NCT03868930
Collaborators
Not Provided
Investigators
Principal Investigator: Catherine B Fortier, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA