Partner-Assisted Therapy for PTSD
(COOPERATE Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Laura Meis, PhD
Principal Investigator
University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System
Leslie Morland, PhD
Principal Investigator
National Center for PTSD; San Diego VA Healthcare System
Eligibility Criteria
This trial is for post-9/11 US Service Members with PTSD. Participants should be willing to involve their partners in the treatment process. The study excludes those who may not fully benefit from partnered therapy or have conditions that could interfere with the effectiveness of the treatments being tested.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Partnered Prolonged Exposure (PPE) or Prolonged Exposure (PE) therapy, with intimate partners attending weekly sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months posttreatment
Treatment Details
Interventions
- Partnered Prolonged Exposure (PPE)
- Prolonged Exposure (PE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
United States Department of Defense
Lead Sponsor
Lowcountry Center for Veterans Research
Collaborator
Veterans Medical Research Foundation
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
San Diego Veterans Healthcare System
Collaborator
Charleston VA Healthcare System
Collaborator
Arizona Veterans Research and Education Foundation
Collaborator
University of Minnesota
Collaborator
VA Palo Alto Health Care System
Collaborator
Atlanta VA Medical Center
Collaborator