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Search / Trial NCT05267665

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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Feb 23, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Posttraumatic Stress Disorder Ptsd Veteran Family Treatment

ClinConnect Summary

The FIT-PTSD study is exploring a new way to help Veterans with Posttraumatic Stress Disorder (PTSD) by involving their family members in their treatment. The goal is to see if a brief family intervention can improve treatment outcomes and reduce the number of Veterans who drop out of therapy. Currently, many Veterans want their families to be part of their care, and earlier tests suggest that involving family members can lead to better results. In this study, 100 Veteran-family pairs will be recruited, and families will either receive this new intervention or not. The researchers will track how well Veterans respond to their PTSD treatments and whether they stay in therapy longer.

To be eligible for the study, Veterans must have a diagnosis of PTSD, be starting a specific type of therapy (Cognitive Processing Therapy or Prolonged Exposure), and be open to having a family member participate. Family members must be 18 or older and have regular contact with the Veteran. Participants can expect to attend a couple of sessions together, and their progress will be monitored over several weeks. This trial is an important step in finding new ways to support Veterans and their families in managing PTSD.

Gender

ALL

Eligibility 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Boston, Massachusetts, United States

Cincinnati, Ohio, United States

Durham, North Carolina, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Johanna Thompson-Hollands, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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