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

Recruiting now · Not applicable

Conditions studied: Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID: NCT05267665
Run by: VA Office of Research and Development
People needed: 200
Starts: 2022-07-01
Expected to finish: 2027-03-31
Last updated by the study team: 2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Inclusion criteria for Veterans will include:
a current DSM-5 diagnosis of PTSD
Veteran status
willing to have a family member involved in the study
has recently begun or is currently initiating individual CPT or PE (completed no more than 3 sessions of the protocol at the time of the baseline assessment)
If taking psychotropic medication, the Veteran must be on a stable dose for at least 30 days.
Inclusion criteria for family members will include:
age 18 or older, family member of the Veteran (significant other, parent, adult child, sibling, etc.)
currently having frequent contact with the Veteran (three or more times per week)

You may not qualify if…

Exclusion criteria for Veterans will include:
current engagement in couple/family treatment with the identified family member participant
current severe substance use disorder (mild/moderate use disorders will not be excluded; any level of nicotine or caffeine use disorder accepted)
current psychosis or unstable bipolar disorder diagnosis
high suicidal risk
significant cognitive impairment
Exclusion criteria for family members will include:
same as listed for Veterans. Additionally
family members will NOT be permitted to participate if they meet criteria for current PTSD

Where it is running

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (enrolling)
Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (enrolling)
Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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