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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267665
• Other study ID #: MHBP-005-21S
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Johanna Thompson-Hollands, PhD
• Phone: (857) 364-2067
• Email: Johanna.Thompson-Hollands[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	Cincinnati VA Medical Center, Cincinnati, OH	Cincinnati	Ohio
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Homework compliance	Compliance with assigned homework during treatment. Minimum score is 0 (worst possible), maximum score is 150 (best possible).	Week 26
Secondary	Quality of Life Inventory (QOLI)	Quality of life. Minimum score is -6 (worst possible), maximum score is 6 (best possible).	Week 26