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NCT Number: NCT05267665

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 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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Family Intervention (BFI)

Behavioral

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

Primary outcomes

  1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    Time frame: Week 26

    Severity of PTSD symptoms. Minimum score is 0 (best possible, no symptoms) and maximum score is 80 (worst possible, highest symptoms).

  2. Adequate treatment dose

    Time frame: Week 26

    Categorical evaluation of whether the participant received 8 or more on-protocol sessions of CPT or PE during their 26-week study participation period. Possible scores are 0 (meaning <8 sessions received; this is considered a poor outcome) or 1 (meaning 8 or more sessions received; this is considered a good outcome).

  3. Treatment dropout

    Time frame: Week 26

    Categorical evaluation of whether the participant dropped out of treatment early. Possible scores are 0 (meaning participant did not drop out of treatment early; this is considered a good outcome) or 1 (meaning participant did drop out of treatment early; this is considered a poor outcome).

Secondary outcomes

  1. Homework compliance

    Time frame: Week 26

    Compliance with assigned homework during treatment. Minimum score is 0 (worst possible), maximum score is 150 (best possible).

  2. Quality of Life Inventory (QOLI)

    Time frame: Week 26

    Quality of life. Minimum score is -6 (worst possible), maximum score is 6 (best possible).

Study contacts

Contact information is provided by the study sponsor or research team.

Cameron Busser, BA

CONTACT

[email protected]

(857) 364-4143

Johanna Thompson-Hollands, PhD

CONTACT

[email protected]

(857) 364-2067

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2022
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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