RecruitingNot ApplicableNCT05267665

Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement


Sponsor

VA Office of Research and Development

Enrollment

200 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention. Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether involving a family member in PTSD treatment helps veterans stay in therapy longer and recover better. Veterans receiving standard talk therapy (CPT or PE) will be paired with a family member who joins some sessions. **You may be eligible if...** - You are a veteran with a current PTSD diagnosis - You have recently started or are about to start individual CPT or PE therapy (no more than 3 sessions completed) - You are willing to have a family member participate - If you take psychiatric medication, your dose has been stable for at least 30 days - Family members must be 18 or older and in frequent contact with the veteran (3+ times per week) **You may NOT be eligible if...** - You are already in couples or family therapy with the same family member - You have a severe substance use disorder (mild or moderate is okay) - Your family member is unwilling or unable to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBrief Family Intervention (BFI)

A 2-session psychoeducational and skills-based family intervention.


Locations(3)

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

Boston, Massachusetts, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, United States

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NCT05267665


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