Family involvement to improve PTSD treatment outcomes
Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
This study is testing whether involving family members in therapy can help Veterans with PTSD stick with their treatment and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT05267665 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the treatment of Posttraumatic Stress Disorder (PTSD) in Veterans by incorporating family members into the therapeutic process. It focuses on a Brief Family Intervention (BFI) designed to complement existing evidence-based treatments like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE). The study will assess the effectiveness of the BFI in reducing dropout rates and improving PTSD symptoms among Veterans who have recently started individual therapy. Preliminary results indicate that family involvement can significantly boost retention and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include Veterans with a current DSM-5 diagnosis of PTSD who are willing to involve a family member in their treatment.
Not a fit: Patients currently engaged in couple or family treatment with the identified family member will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment retention and reduced PTSD symptoms for Veterans.
How similar studies have performed: Preliminary testing of similar family-based interventions has shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 2 other locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Recruiting)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Recruiting)
- Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Johanna Thompson-Hollands, PhD — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Study coordinator: Johanna Thompson-Hollands, PhD
- Email: Johanna.Thompson-Hollands@va.gov
- Phone: (857) 364-2067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.