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

Conditions

• Posttraumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brief Family Intervention (BFI) — BEHAVIORAL
  A 2-session psychoeducational and skills-based family intervention.

Study Details

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 Dates

Start date

Jul 1, 2022

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BFI
  Family members in this arm receive the 2-session BFI intervention.
• No Intervention: No BFI
  Family members in this arm do not receive the BFI sessions

Primary Outcome Measure

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Week 26 ]

Central Contacts

• Johanna Thompson-Hollands, PhD
  (857) 364-2067
  [email protected]
• Cameron Busser, BA
  (857) 364-4143
  [email protected]

Locations (3)

Find similar trials in Boston, MA

Related Studies

• Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy
  Enrolling By Invitation · Milissa Kaufman · Belmont, Massachusetts
• Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
  Recruiting · Boston University Charles River Campus · Boston, Massachusetts
• A Precision Medicine Approach to Target Engagement for Emotion Regulation
  Recruiting · Matthew Southward, PhD · Columbus, Ohio
• Mechanisms Underlying the Efficacy of Prolonged Exposure
  Recruiting · VA Boston Healthcare System · Boston, Massachusetts