Clinical trial NCT05267665: Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
Official title: Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic stress disorder
PTSD
Veteran
Family treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Family members are randomly assigned to one of the following two groups: Brief Family Intervention (BFI) where they receive a 2-session intervention designed to help them better understand and support the Veteran's individual trauma-focused treatment, or no BFI where they do not receive the BFI sessions.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Week 26
measure: Adequate treatment dose
timeFrame: Week 26
measure: Treatment dropout
timeFrame: Week 26
Secondary outcomes:
measure: Homework compliance
timeFrame: Week 26
measure: Quality of Life Inventory (QOLI)
timeFrame: Week 26
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Johanna Thompson-Hollands, PhD
role: PRINCIPAL_INVESTIGATOR
References: