Clinical trial NCT06990191: A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
Official title: A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Trauma-focused therapies
Prolonged exposure
Veterans
Integrative Behavioral Couples Therapy
couples
PTSD
Lead sponsor: United States Department of Defense
Sponsor class: FED
Collaborators: name: University of Minnesota
name: Center for Veterans Research and Education
name: Arizona Veterans Research and Education Foundation
name: Lowcountry Center for Veterans Research
name: Veterans Medical Research Foundation
name: Minneapolis Veterans Affairs Medical Center
name: VA Palo Alto Health Care System
name: Atlanta VA Medical Center
name: Tampa VA Healthcare System
name: San Diego Veterans Healthcare System
name: Charleston VA Healthcare System
name: Phoenix VA Health Care System
First posted: 2025-05-25
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Post-9/11 Veteran Enrolled in VHA
* 1 \> mo stable medication
* Committed relationship 6+ months
* DSM-5-R PTSD Diagnosis

Exclusion Criteria:

* 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

Primary outcomes:
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Secondary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline, posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. follow-up, 6 month follow-up
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Other outcomes:
measure: Couples satisfaction index
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
measure: Perceived Stress Scale
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
measure: Short Zarit Burden Interview
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
measure: WHO Disability Assessment Schedule (WHO-DAS 2.0)
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
measure: Inventory of Psychosocial Functioning (IPF) - Romantic functioning scale on partners
timeFrame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Healthcare System
state: Arizona
city: San Diego
country: United States
facility: San Diego VA Healthcare System
state: California
city: Minneapolis
country: United States
facility: Minneapolis VA Healthcare System
state: Minnesota
city: Charleston
country: United States
facility: Charleston VA Healthcare System
state: South Carolina
Study officials:
affiliation: University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System
name: Laura Meis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for PTSD; San Diego VA Healthcare System
name: Leslie Morland, PhD
role: PRINCIPAL_INVESTIGATOR
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