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

Study Overview
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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.

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Brief Family Intervention (BFI)


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFI<br>Family members in this arm receive the 2-session BFI intervention. | Behavioral: Brief Family Intervention (BFI)<br>* A 2-session psychoeducational and skills-based family intervention.<br>|
| No Intervention: No BFI<br>Family members in this arm do not receive the BFI sessions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week 26 | 
| 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). | Week 26 | 
| 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). | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homework compliance | Compliance with assigned homework during treatment. Minimum score is 0 (worst possible), maximum score is 150 (best possible). | Week 26 | 
| Quality of Life Inventory (QOLI) | Quality of life. Minimum score is -6 (worst possible), maximum score is 6 (best possible). | Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic stress disorder, PTSD, Veteran, Family treatment