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?

This trial explores whether involving family members can improve treatment outcomes for Veterans with PTSD who already receive standard treatments, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE). The focus is on a new Brief Family Intervention (BFI) that educates and equips families to support Veterans through a two-session program. Veterans who have started CPT or PE and wish to involve their family, along with family members who frequently interact with them, might be a good fit. The goal is to determine if family participation reduces dropout rates and enhances recovery from PTSD. As an unphased trial, this study offers Veterans and their families a unique opportunity to contribute to innovative PTSD treatment strategies.

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 prior data suggests that the Brief Family Intervention (BFI) is safe for family involvement in PTSD treatment?

Research has shown that involving family in PTSD treatment can be helpful. In a previous study, a Brief Family Intervention (BFI) demonstrated promising results. Family members participated in a two-session program, which reduced the dropout rate from PTSD therapy by half. Veterans whose families participated also experienced significant improvements in their PTSD symptoms.

Regarding safety, no specific data indicates harmful effects from the BFI. The program is primarily educational and supportive, aiming to strengthen family relationships. This approach is generally well-received, and studies related to the BFI have reported no negative effects.

Overall, the BFI appears to be a safe way to support Veterans with PTSD by involving their families in a structured program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Family Intervention (BFI) for PTSD because it focuses on involving family members in the treatment process. Unlike traditional treatments that primarily focus on individual therapy or medication, BFI offers a unique, two-session intervention that actively engages family members to support the person with PTSD. This approach emphasizes the importance of family dynamics and social support, which can enhance treatment outcomes and provide a more holistic method of addressing PTSD symptoms. By involving loved ones, BFI has the potential to create a stronger support network, which might lead to better long-term results for those affected by PTSD.

What evidence suggests that the Brief Family Intervention is effective for PTSD?

Research has shown that involving family members in PTSD treatment can greatly improve results. In this trial, some participants will receive the Brief Family Intervention (BFI), which has shown promising results in early tests. Specifically, veterans whose families participated in the BFI were 50% less likely to stop therapy and experienced significant improvement in PTSD symptoms, with a strong positive effect for those in the BFI group. This suggests that the BFI can enhance existing PTSD treatments like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) by potentially increasing both the likelihood of completing treatment and the improvement of symptoms. ^{1 3 5 6 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

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]

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 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05267665

Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, ... Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9362012/

Family Involvement in PTSD Treatment: Perspectives from a ... Discussion. Our results indicate that clinicians felt positively about family involvement; they recognized the significant impact of PTSD on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8555692/

The Use of a Brief Family Intervention to Reduce Dropout ... Family involvement may help to increase the effectiveness of PTSD treatment while also improving retention. We tested a two-session brief family intervention ( ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722920300791

Development of a Brief Adjunctive Intervention for Family ... Family involvement in the treatment of posttraumatic stress disorder (PTSD) among veterans has the potential to improve treatment retention and outcomes.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813182

Retention in Individual Trauma-Focused Treatment ... Preliminary efficacy data shows that brief, family-based interventions may improve treatment retention in a veteran's individual PTSD treatment ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05267665?tab=table

Family Involvement in Treatment for PTSD (FIT ... Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666560322000548

Adapting a family-involved intervention to increase ... Positive and empathetic family interactions may increase feelings of safety for individuals with PTSD (Charuvastra and Cloitre, 2008); as such, supportive ...