Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
1 other identifier
interventional
200
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 20, 2026
March 1, 2026
4.8 years
February 23, 2022
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Homework compliance
Week 26
Quality of Life Inventory (QOLI)
Week 26
Study Arms (2)
BFI
EXPERIMENTALFamily members in this arm receive the 2-session BFI intervention.
No BFI
NO INTERVENTIONFamily members in this arm do not receive the BFI sessions
Interventions
A 2-session psychoeducational and skills-based family intervention.
Eligibility Criteria
You may qualify if:
- 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.
- 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)
You may not qualify if:
- 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
- same as listed for Veterans. Additionally
- family members will NOT be permitted to participate if they meet criteria for current PTSD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johanna Thompson-Hollands, PhD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessors are blind to the condition of the family member/Veteran
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 4, 2022
Study Start
July 1, 2022
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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.
- Access Criteria
- Individual requesting access to the data will be required to complete an adequate Data Use Agreement.
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).