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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brief Family Intervention (BFI)

    Behavioral

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: BFIExperimental treatment 1 intervention
Group B: No BFINo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Severity of PTSD symptoms. Minimum score is 0 (best possible, no symptoms) and maximum score is 80 (worst possible, highest symptoms).

Time frame
Week 26
2

Adequate treatment dose

Categorical evaluation of whether the participant received 8 or more on-protocol sessions of CPT or PE during their 26-week study participation period. Possible scores are 0 (meaning \<8 sessions received; this is considered a poor outcome) or 1 (meaning 8 or more sessions received; this is considered a good outcome).

Time frame
Week 26
3

Treatment dropout

Categorical evaluation of whether the participant dropped out of treatment early. Possible scores are 0 (meaning participant did not drop out of treatment early; this is considered a good outcome) or 1 (meaning participant did drop out of treatment early; this is considered a poor outcome).

Time frame
Week 26

Secondary outcomes

1

Homework compliance

Compliance with assigned homework during treatment. Minimum score is 0 (worst possible), maximum score is 150 (best possible).

Time frame
Week 26
2

Quality of Life Inventory (QOLI)

Quality of life. Minimum score is -6 (worst possible), maximum score is 6 (best possible).

Time frame
Week 26

Other outcomes

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