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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Family members are randomly assigned to one of the following two groups: Brief Family Intervention (BFI) where they receive a 2-session intervention designed to help them better understand and support the Veteran's individual trauma-focused treatment, or no BFI where they do not receive the BFI sessions.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessors are blind to the condition of the family member/Veteran

Study Groups

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BFI

Family members in this arm receive the 2-session BFI intervention.

Group Type EXPERIMENTAL

Brief Family Intervention (BFI)

Intervention Type BEHAVIORAL

A 2-session psychoeducational and skills-based family intervention.

No BFI

Family members in this arm do not receive the BFI sessions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief Family Intervention (BFI)

A 2-session psychoeducational and skills-based family intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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

* same as listed for Veterans. Additionally
* family members will NOT be permitted to participate if they meet criteria for current PTSD

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No