Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Family involvement to improve PTSD treatment outcomes

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

Run by VA Office of Research and Development · NCT05267665 · Data updated 2026-11-12

This study is testing whether involving family members in therapy can help Veterans with PTSD stick with their treatment and feel better.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorVA Office of Research and Development
Federal
Locations3 sites (Boston, Massachusetts and 2 other locations)
StatusRecruiting
StartedJuly 1, 2022
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedMarch 20, 2026
Trial IDNCT05267665 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients currently engaged in couple or family treatment with the identified family member will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Preliminary testing of similar family-based interventions has shown promising results, indicating potential for success in this approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Reboxetine plus Ritalin vs Dog-Assisted Therapy for PTSD

    This study tests whether a drug combo of reboxetine and methylphenidate works better than dog-assisted therapy for people with PTSD.

    Recruiting Phase 2 University of Haifa · Haifa · NCT07771530

  • Self-Help CPT with WoVeN Peer Support for Women Veterans with PTSD

    This study tests a self-help Cognitive Processing Therapy and a WoVeN peer-support program, alone and together, to see if they improve PTSD symptoms and well-being for women veterans.

    Recruiting Boston University · Boston, Massachusetts · NCT07250061

  • Adaptive, personalized PTSD care for veterans

    This program will try different therapy sequences plus optional text-message homework reminders to see if switching treatments or sending prompts helps veterans with PTSD who aren't improving or are missing between-session homework.

    Recruiting at 3 sites The University of Texas Health Science Center at San Antonio · Augusta, Georgia and 3 other locations · NCT07176273

  • Multi‑Mode Cognitive Processing Therapy for adults with PTSD

    This program will try a multi‑mode form of Cognitive Processing Therapy to reduce PTSD symptoms and improve sleep and mood in adults aged 20–65 with PTSD.

    Recruiting Far Eastern Memorial Hospital · New Taipei City, Banqiao District · NCT07105345

  • Improving thinking, daily functioning, mood, and sleep after mild traumatic brain injury and PTSD

    This project will test whether adding morning bright light therapy to compensatory cognitive training helps post-9/11 Veterans with mild traumatic brain injury and PTSD think, function, and sleep better compared with a neutral ion generator.

    Recruiting at 2 sites VA Office of Research and Development · San Diego, California and 1 other locations · NCT07055633

  • Combined MDMA and psilocybin treatment for Veterans with PTSD

    This trial tests whether giving MDMA followed 30 minutes later by psilocybin can be safely used to reduce symptoms in military veterans with long-standing PTSD.

    Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT06989957

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.