Family Involvement for PTSD

Recruiting at 2 trial locations

Overseen By Cameron Busser, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe substance use, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 26 weeks

200 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 7}

Who Is on the Research Team?

Johanna Thompson-Hollands, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: BFI Experimental Treatment 1 Intervention

Family members in this arm receive the 2-session BFI intervention.

Group II: No BFI Active Control 1 Intervention

Family members in this arm do not receive the BFI sessions

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Family-focused therapy (FFT) can be adapted to support military personnel with traumatic brain injury (TBI) by addressing the complex stressors they face upon returning from combat, including mental health and family dynamics.

This approach emphasizes the importance of family intervention in rehabilitation, suggesting that enhancing both individual and family functioning may improve outcomes for those with moderate to severe TBI, although further research is needed to establish its feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of family focused therapy in rehabilitation for veterans with traumatic brain injury. Dausch, BM., Saliman, S.[2013]

A workshop titled 'PTSD 101 for Family and Friends' was developed for loved ones of veterans with PTSD, involving 181 participants who rated the workshop highly for quality (4.76) and relevance (4.82), indicating it effectively provided valuable information and support.

The workshop not only improved participants' understanding of PTSD (4.76) and self-efficacy (4.41) but also fostered a sense of community and shared experience, making it a promising intervention for enhancing the support system for veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a brief support and education intervention for loved ones of veterans with posttraumatic stress disorder. Campbell, SB., Caska Wallace, CM.[2023]

In a study of 67 veterans undergoing trauma-focused therapies for PTSD, dropout rates were significant, with 22.4% leaving before the fourth session and only 16.4% completing the treatment.

Among those who completed the therapy, 90.9% were rated as improved by their therapists, highlighting the efficacy of trauma-focused treatments for veterans who stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiation, dropout, and outcome from evidence-based psychotherapies in a VA PTSD outpatient clinic. Niles, BL., Polizzi, CP., Voelkel, E., et al.[2022]

A study involving qualitative interviews with 31 clinicians from 10 Veterans Health Administration facilities revealed that while clinicians recognize the importance of family involvement in PTSD treatment, actual rates of such involvement remain low.

Clinicians' comfort with including families in treatment sessions is significantly influenced by their previous experiences with family-based therapy, suggesting that enhancing training and support for providers could improve family engagement in veterans' mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Involvement in PTSD Treatment: Perspectives from a Nationwide Sample of Veterans Health Administration Clinicians. Thompson-Hollands, J., Rando, AA., Stoycos, SA., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Development and initial testing of a brief adjunctive intervention for family members of veterans in individual PTSD treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Veteran interest in family involvement in PTSD treatment. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Use of a Brief Family Intervention to Reduce Dropout Among Veterans in Individual Trauma-Focused Treatment: A Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Use of family focused therapy in rehabilitation for veterans with traumatic brain injury. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Development of a brief support and education intervention for loved ones of veterans with posttraumatic stress disorder. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Initiation, dropout, and outcome from evidence-based psychotherapies in a VA PTSD outpatient clinic. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Family Involvement in PTSD Treatment: Perspectives from a Nationwide Sample of Veterans Health Administration Clinicians. [2023]