Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05267665

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

Led by VA Office of Research and Development · Updated on 2026-03-20

200

Participants Needed

3

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veteran with a current DSM-5 diagnosis of PTSD
  • Veteran status
  • Willingness to involve a family member in the study
  • Recently started or currently initiating individual CPT or PE treatment with no more than 3 protocol sessions completed at baseline
  • If on psychotropic medication, stable dose for at least 30 days
  • Family member aged 18 or older and related as significant other, parent, adult child, sibling, etc.
  • Family member has frequent contact with Veteran (three or more times per week)
Not Eligible

You will not qualify if you...

  • Current engagement in couple or family therapy with the identified family member
  • Current severe substance use disorder (mild or moderate use disorders allowed; nicotine or caffeine use disorder allowed)
  • Current psychosis or unstable bipolar disorder
  • High suicidal risk
  • Significant cognitive impairment
  • Family members meeting the same exclusion criteria as Veterans
  • Family members with current PTSD are not allowed to participate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

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

Boston, Massachusetts, United States, 02130-4817

Actively Recruiting

2

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Actively Recruiting

3

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, United States, 45220

Actively Recruiting

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Research Team

J

Johanna Thompson-Hollands, PhD

CONTACT

C

Cameron Busser, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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