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NCT05267665 · ClinicalTrials.gov registry record · NA
Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
A NA study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT05267665: Recruiting NA study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
NCT05267665 is a NA study of Post Traumatic Stress Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 200 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (70% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05267665, a NA study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Severity of PTSD symptoms. Minimum score is 0 (best possible, no symptoms) and maximum score is 80 (worst possible, highest symptoms).
Conditions Studied
Interventions
- BEHAVIORAL Brief Family Intervention (BFI)
Study Locations (3)
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Ohio
- Cincinnati VA Medical Center, Cincinnati, OH - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT05267665 shows while recruiting
NCT05267665 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Brief Family Intervention (BFI) is the first listed.
NCT05267665 reports a single indexed study location in Massachusetts, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT05267665 about?
NCT05267665 is a clinical study titled "Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement". 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 i...
What is the current status of trial NCT05267665?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2022-07-01. Estimated completion is 2027-03-31.
What conditions does trial NCT05267665 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05267665?
The interventions under investigation include: Brief Family Intervention (BFI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05267665?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05267665 being conducted?
This trial has 3 study locations across Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05267665's enrollment target sits among peer trials
200 47th of 262 higher than 207 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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