Recruiting

FIT-PTSD

Sponsor:

VA Office of Research and Development

Code:

NCT05267665

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief Family Intervention (BFI)

Study Details

Brief 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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT05267665

Start date

Jul 1, 2022

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BFI

Family members in this arm receive the 2-session BFI intervention.

no intervention: No BFI

Family members in this arm do not receive the BFI sessions

Interventions

Brief Family Intervention (BFI)

A 2-session psychoeducational and skills-based family intervention.

Primary outcome measure

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Week 26 ]
  • Adequate treatment dose [ Time Frame: Week 26 ]
  • Treatment dropout [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Principal Investigator:

Johanna Thompson-Hollands, PhD

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Cincinnati VA Medical Center, Cincinnati, OH

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Posttraumatic stress disorder
  • PTSD
  • Veteran
  • Family treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-20.