Actively Recruiting
A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
Led by United States Department of Defense · Updated on 2025-11-14
420
Participants Needed
4
Research Sites
171 weeks
Total Duration
On this page
Sponsors
U
United States Department of Defense
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-9/11 Veteran enrolled in the VA health system
- Stable medication for more than 1 month
- In a committed relationship lasting 6 months or longer
- Diagnosed with PTSD according to DSM-5 criteria
You will not qualify if you...
- Imminent risk of suicide or homicide
- Mania, psychosis, or severe substance use disorder within the past 3 months
- Severe cognitive impairment
- Severe intimate partner violence in the last 6 months
- Fear of or intimidation by partner
- Partner has a positive screen for PTSD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Phoenix VA Healthcare System
Phoenix, Arizona, United States, 85012
Not Yet Recruiting
2
San Diego VA Healthcare System
San Diego, California, United States, 92161
Actively Recruiting
3
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States, 55417
Not Yet Recruiting
4
Charleston VA Healthcare System
Charleston, South Carolina, United States, 29401
Not Yet Recruiting
Research Team
E
Emily M Hudson, PhD
CONTACT
D
Donald Lemon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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