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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Brief Family Intervention (BFI)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna Thompson-Hollands, PhD; Phone Number: (857) 364-2067; Email: Johanna.Thompson-Hollands@va.gov
• Study Contact Backup: Name: Cameron Busser, BA; Phone Number: (857) 364-4143; Email: cameron.busser@va.gov

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • Recruiting
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
      • Contact: Johanna Thompson-Hollands, PhD; Phone Number: 857-364-2067; Email: Johanna.Thompson-Hollands@va.gov
      • Principal Investigator: Johanna Thompson-Hollands, PhD
      • Contact: Cameron Busser, BA; Phone Number: (857) 364-4143; Email: cameron.busser@va.gov
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Recruiting
      • Durham VA Medical Center, Durham, NC
      • Contact: Nicole Pukay-Martin, PhD; Phone Number: 17-7548 919-286-0411; Email: nicole.pukay-martin@va.gov
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Recruiting
      • Cincinnati VA Medical Center, Cincinnati, OH
      • Contact: Nicole Pukay-Martin, PhD; Phone Number: 3251 513-861-3100; Email: nicole.pukay-martin@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFI; Family members in this arm receive the 2-session BFI intervention.	Behavioral: Brief Family Intervention (BFI); A 2-session psychoeducational and skills-based family intervention.
No Intervention: No BFI; Family members in this arm do not receive the BFI sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	Severity of PTSD symptoms. Minimum score is 0 (best possible, no symptoms) and maximum score is 80 (worst possible, highest symptoms).	Week 26
Adequate treatment dose	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).	Week 26
Treatment dropout	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).	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homework compliance	Compliance with assigned homework during treatment. Minimum score is 0 (worst possible), maximum score is 150 (best possible).	Week 26
Quality of Life Inventory (QOLI)	Quality of life. Minimum score is -6 (worst possible), maximum score is 6 (best possible).	Week 26

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Johanna Thompson-Hollands, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Veteran; Posttraumatic stress disorder; Family treatment
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MHBP-005-21S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: An anonymous dataset that meets VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distributions, a privacy officer at the primary site will certify that all datasets contain no PHI. The PI will create a de-identified dataset that will include all publication variables. To remove some PHI, loss of information may occur. The PI will replace any identifiable information with study-specific numbers. Data collected on age will be replaced by the PI with age categories to ensure data is in accordance with PHI requirements for people 85 years of age and older (if applicable).
• IPD Sharing Time Frame: An anonymous dataset that meets VA standards for disclosure to the public will be made available within 1 year of publication. The data will be made available until the data is destroyed according to the required timelines in the VA Record Control Schedule.
• IPD Sharing Access Criteria: Individual requesting access to the data will be required to complete an adequate Data Use Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No