Family Involvement for PTSD
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Severe substance use, Psychosis, Bipolar, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
12346How 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.
12347Eligibility 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.
+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.
+6 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Durham VA Medical Center, Durham, NCDurham, NC
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, MA
Cincinnati VA Medical Center, Cincinnati, OHCincinnati, OH
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Development and initial testing of a brief adjunctive intervention for family members of veterans in individual PTSD treatment. [2022]Family involvement in the treatment of posttraumatic stress disorder (PTSD) among veterans has the potential to improve treatment retention and outcomes. Current protocols that incorporate family members into treatment tend to involve at least 15 sessions, and none are designed to complement Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE), the two most widely used and heavily promoted evidence-based PTSD therapies in the Veterans Affairs (VA) healthcare system. The current paper describes the development and initial feasibility and acceptability of a Brief Family Intervention (the BFI) designed to be delivered as an adjunct to veterans' individual CPT/PE. The BFI focuses on providing psychoeducation about PTSD and treatment, building family member support for treatment, and reducing family symptom accommodation. A detailed review of the treatment structure and activities is provided, and qualitative data from four dyads (veterans and their spouses/significant others) at baseline and post-intervention are presented. Veterans and partners reported positive responses to the program and were enthusiastic about its utility. Larger randomized controlled studies will be needed to determine the protocol's efficacy and effectiveness.
Veteran interest in family involvement in PTSD treatment. [2019][Correction Notice: An erratum for this article was reported in Vol 7(3) of Psychological Services (see record 2010-17074-004). The copyright for the article was listed incorrectly. This article is in the Public Domain. The online version has been corrected.] The present study examined interest in family involvement in treatment and preferences concerning the focus of family oriented treatment for veterans (N = 114) participating in an outpatient Veterans Affairs outpatient posttraumatic stress disorder (PTSD) program. Most veterans viewed PTSD as a source of family stress (86%) and expressed interest in greater family involvement in their treatment (79%). These results suggest the need to consider increasing family participation in the clinical care of individuals with PTSD and to develop specialized family educational and support services for this population. (PsycINFO Database Record (c) 2016 APA, all rights reserved)
The Use of a Brief Family Intervention to Reduce Dropout Among Veterans in Individual Trauma-Focused Treatment: A Randomized Controlled Trial. [2022]Dropout from trauma-focused treatment for posttraumatic stress disorder (PTSD) represents a daunting challenge for the field, particularly among military and veteran samples. Family involvement may help to increase the effectiveness of PTSD treatment while also improving retention. We tested a two-session brief family intervention (BFI) protocol delivered as an adjunct to individual trauma-focused treatment among a sample of 20 veteran-family member dyads (N = 40). Willingness to participate in the family-inclusive protocol was high, with over 85% of veterans and family members who were screened agreeing to take part. All enrolled veterans were beginning a course of either cognitive processing therapy (CPT) or prolonged exposure (PE), delivered in outpatient Veterans Affairs clinics. Family members were randomized to either receive or not receive the BFI from study clinicians. In the BFI condition, 20.0% of veterans dropped out of CPT/PE before the 16-week study end; the remainder were either still attending on-protocol sessions or had completed the full protocol. In the control condition, 40.0% of veterans dropped out of CPT/PE before the end of the study. Observed significant, large-magnitude decreases in PTSD symptoms over time did not differ by condition, ESsg range = -1.12 to -2.04. Accommodation did not significantly decrease over time in either condition, ESsg range = 0.18 to -0.98. The BFI represents a promising option for veterans, family members, and clinicians who are seeking a brief, feasible, narrowly focused method for incorporating families into veterans' individual trauma-focused therapy and potentially reducing the rate of dropout.
Use of family focused therapy in rehabilitation for veterans with traumatic brain injury. [2013]Military personnel returning from Iraq and Afghanistan with traumatic brain injury (TBI) present with a complex array of stressors encountered during combat as well as upon re-entry, often with additional physical and mental health comorbidities. This requires an intensive approach to treatment that includes family intervention as a part of rehabilitation. There is a small but growing literature addressing the needs of families when a family member has sustained a TBI. An established treatment intervention for individuals with serious mental illness, such as family focused therapy (FFT), is uniquely suited to address the complexity of issues presented by returning military personnel, and may be adapted for moderate to severe TBI populations. In this article, we discuss the rationale for adapting this family intervention for this population and present a case vignette illustrating adaptations for TBI.
Development of a brief support and education intervention for loved ones of veterans with posttraumatic stress disorder. [2023]Clinical practice guidelines for managing posttraumatic stress disorder (PTSD) encourage incorporating loved ones into treatment, and supportive relationships can increase engagement in mental health care for veterans with PTSD. This study describes the iterative refinement, feasibility/acceptability testing, and national dissemination of a brief support and psychoeducation intervention for loved ones of veterans with PTSD. Loved ones (n = 181; range:1-11 per group) attended and qualitatively rated "PTSD 101 for Family and Friends: A Support and Education Workshop." Open-ended questions were used to gather data on suggestions for improvement and descriptions of helpful content, and the workshop was refined following participant and operational partner feedback using a quality improvement framework. Rating quantitative items on a 1-5 scale, participants found the overall quality (M = 4.76) and relevance (M = 4.82) to be excellent, noting they learned substantial new information (M = 4.45). Sense of support (M = 4.95), intentions to use the material (M = 4.87), PTSD self-efficacy (M = 4.41), and understanding of PTSD (M = 4.76) were rated favorably. Common themes among helpful elements were a sense of shared experience and optimism and increased knowledge of treatments/resources. Suggestions for improvement referenced logistics. Following continual stakeholder feedback and refinement, the workshop represents a novel method for providing loved ones with empirically supported psychoeducation, coping skills, and community. It is being disseminated by the Family Services Section of the Veterans Health Administration Office of Mental Health and Suicide Prevention.
Initiation, dropout, and outcome from evidence-based psychotherapies in a VA PTSD outpatient clinic. [2022]Trauma-focused, evidence-based psychotherapies (TF-EBPs) for posttraumatic stress disorder (PTSD) have been widely promoted in the Veterans Health Administration to provide access to state-of-the-art treatments, but dropout rates may affect the impact of TF-EBPs. The current study summarizes findings from a program evaluation of 67 veterans assigned to trauma-focused treatment in a Veterans Affairs outpatient PTSD clinic. Outcomes of interest include attendance rates, dropout rates and patterns, treatment paths, changes in self-reported symptoms, and clinician ratings. Nine veterans (13.4%) did not attend a first session and 15 (22.4%) dropped out before session 4. Twenty-three (33.8%) received either a modified version of the TF-EBP or switched to a different treatment. Only 11 (16.4%) completed the assigned TF-EBP, but 10 of those 11 (90.9%) were rated by their therapist as improved. These results align with previous research documenting high dropout rates from PTSD treatment in veterans and substantial improvements for those who complete TF-EBPs. Future study of methods to enhance retention in TF-EBP treatments is needed. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
Family Involvement in PTSD Treatment: Perspectives from a Nationwide Sample of Veterans Health Administration Clinicians. [2023]Social support is bidirectionally linked to symptoms of posttraumatic stress disorder (PTSD). Evidence suggests that family involvement in veterans' mental health treatment is desired by both veterans and family members, and that such involvement has the potential to improve treatment outcomes. However, rates of family involvement are low in the Veterans Health Administration (VHA). We sought to understand VHA clinicians' perspectives on family involvement in PTSD treatment by conducting qualitative interviews with 31 providers at 10 VHA facilities across the U.S. The i-PARIHS framework was used to guide the interviews and analysis, and several major themes were identified. All clinicians reported that they at least occasionally offered family-inclusive sessions, and they frequently referenced both the influence of family behaviors or attitudes on veterans' functioning, and also how veterans' symptoms could cause tremendous disruption in the family. Clinicians' past experience with supervised family- or couple-based work strongly influenced their current comfort with family-inclusive sessions. Multiple potential avenues exist to support increased family involvement in PTSD treatment in VHA.