A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
- Conditions
- Post Traumatic Stress Disorder
- Registration Number
- NCT06990191
- Lead Sponsor
- United States Department of Defense
- Brief Summary
PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (\~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). The investigators found that treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning. For this proposed study, the primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans. The investigator's primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role military sexual trauma history, and treatment mechanisms.
- Detailed Description
Background: PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (\~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). In PPE, intimate partners attend weekly treatment sessions. The study uses strategies from Integrative Behavioral Couples Therapy (ICBT), an efficacious, acceptance-based martial therapy intervention, to help couples support each other during treatment. PPE strives to increase the potency of PE through (1) teaching partners to act as effective PE coaches at home and (2) helping couples discuss trauma-related concerns together, providing an additional laboratory for exposure-based learning. Pilot findings support the feasibility and effectiveness of PPE. Treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning.
Objectives: Our primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans.
Aims: Our primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role of military sexual trauma history, and treatment mechanisms.
Study Design: The study will use a mixed-method two-group Hybrid Type I effectiveness implementation RCT to determine the superiority of PPE to PE. The study team will run the study across three VAs (San Diego, Charleston, and Phoenix) over four-years. The Minneapolis VA will serve as a back-up site. 210 individuals with PTSD and their intimate partners will be randomized to PPE or PE and assessed at baseline, mid-treatment, posttreatment, 3-, and 6-mos posttreatment. The study team will conduct qualitative interviews with study participants, therapists, and clinical administrators to assess barriers and facilitators to PPE implementation to guide future implementation work.
Clinical Impact: The influence of a successful course of PTSD treatment on an individual's life is considerable. However, among current and former Service Members, the most effective treatments for PTSD yield smaller effects and fewer individuals finish them. PPE is well poised to improve the potency of trauma-focused treatment to ensure PE promotes recovery from PTSD for more Service Members. The study team will also explore differences for those with a history of military sexual trauma. Additionally, partnering with significant others during PE can answer long-standing calls for family-centered PTSD care and extend the benefits of PTSD treatment to families. Family involvement in PTSD care is highly desired by Service Members, a fertile avenue for improving the outcomes for patients with PTSD, and a national priority. Such research is critical to military service retention and to the health of the entire military. If PPE is more effective than PE, this proposal could feed the growth of symptom-focused psychotherapies that largely exclude loved ones into systems-based interventions designed to lift the whole person within the context of their important relationships.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
- Post-9/11 Veteran Enrolled in VHA
- 1 > mo stable medication
- Committed relationship 6+ months
- DSM-5-R PTSD Diagnosis
- Imminent suicidality/homicidally
- Mania, psychosis, or severe substance use disorder, past 3 mos
- Severe cognitive impairment
- Severe intimate partner violence in last 6 months
- Fear of or intimidation by partner
- Partner screens positive for PTSD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Inventory of Psychosocial Functioning (IPF) Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. The primary outcome is Veterans' global functioning at posttreatment assessment. The subdimensions of global functioning that matter most to Veterans with PTSD are their relationships with intimate partners, family relationships, work performance, friend relationships, parenting, educational performance, and self-care functioning (e.g., maintaining personal hygiene, exercising, household chores, healthy eating). Outcomes will be measured using the Inventory of Psychosocial Functioning (IPF).
- Secondary Outcome Measures
Name Time Method PTSD Checklist for DSM-5 (PCL-5) Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. Self-report instrument that measures PTSD symptom severity.
Patient Health Questionnaire - 9 (PHQ-9) Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. Self-report instrument that measures depression severity
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Baseline, posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. follow-up, 6 month follow-up Gold standard, structured-clinical interview that assesses PTSD symptom severity.
Trial Locations
- Locations (4)
Phoenix VA Healthcare System
🇺🇸Phoenix, Arizona, United States
San Diego VA Healthcare System
🇺🇸San Diego, California, United States
Minneapolis VA Healthcare System
🇺🇸Minneapolis, Minnesota, United States
Charleston VA Healthcare System
🇺🇸Charleston, South Carolina, United States