200 Participants Needed

Family Involvement for PTSD

Recruiting at 2 trial locations
SL
JT
CB
Overseen ByCameron Busser, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that if you are taking psychotropic medication, you must be on a stable dose for at least 30 days before starting. You don't have to stop your current medications, but they need to be stable.

What data supports the effectiveness of the treatment Brief Family Intervention (BFI) for PTSD?

Research shows that involving family in PTSD treatment can help reduce dropout rates and improve treatment engagement. A study found that veterans who participated in a Brief Family Intervention were less likely to drop out of their individual PTSD therapy compared to those who did not have family involvement.12345

Is the Brief Family Intervention (BFI) safe for use in PTSD treatment?

The Brief Family Intervention (BFI) has been tested with veterans and their family members, showing positive responses and enthusiasm for its use. No safety concerns were reported in the studies, suggesting it is generally safe for human use.12346

How does the Family Involvement treatment for PTSD differ from other treatments?

The Family Involvement treatment for PTSD is unique because it incorporates family members into the therapy process, aiming to improve treatment retention and outcomes by providing education about PTSD and building family support. Unlike other treatments, it is designed to complement existing therapies like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) with a brief, two-session intervention, making it more feasible and focused.12347

What is the purpose of this trial?

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.

Research Team

JT

Johanna Thompson-Hollands, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for Veterans with PTSD who are starting or have just started individual CPT or PE therapy, and are willing to involve a family member. The Veteran must be stable on any psychotropic meds for at least 30 days. Family members over 18 who see the Veteran frequently but don't have PTSD can join.

Inclusion Criteria

I have been diagnosed with PTSD.
I have started CPT or PE therapy and have completed no more than 3 sessions.
I have been on the same dose of my mental health medication for at least 30 days.
See 6 more

Exclusion Criteria

You have significant problems with your memory or thinking abilities.
- family members will NOT be permitted to participate if they meet criteria for current PTSD
You have a serious problem with drug or alcohol addiction.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Veterans begin a course of usual-care CPT or PE, with family members randomized to receive or not receive the BFI

26 weeks
Assessments at baseline, 6-, 12-, 18-, and 26-weeks

Follow-up

Participants are monitored for PTSD symptom severity and treatment retention

4 weeks

Treatment Details

Interventions

  • Brief Family Intervention (BFI)
Trial Overview The study tests if involving family in treatment through a Brief Family Intervention (BFI) helps Veterans with PTSD stick to their therapy better and improve symptoms more than usual care alone. It's a randomized test where some families get BFI while others don't.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BFIExperimental Treatment1 Intervention
Family members in this arm receive the 2-session BFI intervention.
Group II: No BFIActive Control1 Intervention
Family members in this arm do not receive the BFI sessions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

The Brief Family Intervention (BFI) was developed to support veterans undergoing Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) for PTSD, focusing on psychoeducation and family support, and was positively received by participants in initial qualitative assessments.
Initial feedback from four veteran-partner dyads indicated that the BFI was acceptable and beneficial, suggesting potential for improved treatment retention and outcomes, although further research with larger randomized controlled trials is necessary to confirm its efficacy.
Development and initial testing of a brief adjunctive intervention for family members of veterans in individual PTSD treatment.Thompson-Hollands, J., Strage, M., DeVoe, ER., et al.[2022]
A study involving 114 veterans in an outpatient PTSD program found that 86% viewed PTSD as a source of family stress, highlighting the impact of PTSD on family dynamics.
79% of veterans expressed a desire for greater family involvement in their treatment, indicating a need for enhanced family participation and support services in PTSD care.
Veteran interest in family involvement in PTSD treatment.Batten, S., Drapalski, L., Decker, L., et al.[2019]
A brief family intervention (BFI) significantly reduced dropout rates from trauma-focused treatment for PTSD among veterans, with only 20% of participants dropping out compared to 40% in the control group.
Both groups showed large decreases in PTSD symptoms over time, indicating that while the BFI helped with retention, it did not affect the overall efficacy of the trauma-focused therapies like cognitive processing therapy (CPT) or prolonged exposure (PE).
The Use of a Brief Family Intervention to Reduce Dropout Among Veterans in Individual Trauma-Focused Treatment: A Randomized Controlled Trial.Thompson-Hollands, J., Lee, DJ., Sloan, DM.[2022]

References

Development and initial testing of a brief adjunctive intervention for family members of veterans in individual PTSD treatment. [2022]
Veteran interest in family involvement in PTSD treatment. [2019]
The Use of a Brief Family Intervention to Reduce Dropout Among Veterans in Individual Trauma-Focused Treatment: A Randomized Controlled Trial. [2022]
Use of family focused therapy in rehabilitation for veterans with traumatic brain injury. [2013]
Development of a brief support and education intervention for loved ones of veterans with posttraumatic stress disorder. [2023]
Initiation, dropout, and outcome from evidence-based psychotherapies in a VA PTSD outpatient clinic. [2022]
Family Involvement in PTSD Treatment: Perspectives from a Nationwide Sample of Veterans Health Administration Clinicians. [2023]
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