Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief Family Intervention (BFI).
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Brief Family Intervention (BFI)
A 2-session psychoeducational and skills-based family intervention.
Primary outcome measures
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: Week 26]
- Adequate treatment dose [Time frame: Week 26]
- Treatment dropout [Time frame: Week 26]
Secondary outcome measures (2)
- Homework compliance [Time frame: Week 26]
- Quality of Life Inventory (QOLI) [Time frame: Week 26]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
- Durham VA Medical Center, Durham, NC — Durham
- Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati
Identifiers
NCT: NCT05267665 · MHBP-005-21S