Family Involvement for PTSD
Trial Summary
Will I have to stop taking my current medications?
The trial requires that if you are taking psychotropic medication, you must be on a stable dose for at least 30 days before starting. You don't have to stop your current medications, but they need to be stable.
What data supports the effectiveness of the treatment Brief Family Intervention (BFI) for PTSD?
Research shows that involving family in PTSD treatment can help reduce dropout rates and improve treatment engagement. A study found that veterans who participated in a Brief Family Intervention were less likely to drop out of their individual PTSD therapy compared to those who did not have family involvement.12345
Is the Brief Family Intervention (BFI) safe for use in PTSD treatment?
How does the Family Involvement treatment for PTSD differ from other treatments?
The Family Involvement treatment for PTSD is unique because it incorporates family members into the therapy process, aiming to improve treatment retention and outcomes by providing education about PTSD and building family support. Unlike other treatments, it is designed to complement existing therapies like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) with a brief, two-session intervention, making it more feasible and focused.12347
What is the purpose of this trial?
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.
Research Team
Johanna Thompson-Hollands, PhD
Principal Investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Eligibility Criteria
This trial is for Veterans with PTSD who are starting or have just started individual CPT or PE therapy, and are willing to involve a family member. The Veteran must be stable on any psychotropic meds for at least 30 days. Family members over 18 who see the Veteran frequently but don't have PTSD can join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Veterans begin a course of usual-care CPT or PE, with family members randomized to receive or not receive the BFI
Follow-up
Participants are monitored for PTSD symptom severity and treatment retention
Treatment Details
Interventions
- Brief Family Intervention (BFI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor