RecruitingNot Applicable

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

United States200 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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) Exclusion Criteria: 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

What they're measuring

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Timeframe: Week 26

Adequate treatment dose

Timeframe: Week 26

Treatment dropout

Timeframe: Week 26

Trial details

NCT IDNCT05267665

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Johanna Thompson-Hollands, PhD

(857) 364-2067 Johanna.Thompson-Hollands@va.gov

View on ClinicalTrials.gov More Posttraumatic Stress Disorder trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.