NCT06990191 A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
| NCT ID | NCT06990191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | United States Department of Defense |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2025-05-16 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Laura Meis, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System
Frequently Asked Questions
Who can join the NCT06990191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06990191 currently recruiting?
Yes, NCT06990191 is actively recruiting participants. Contact the research team at emily.hudson@va.gov for enrollment information.
Where is the NCT06990191 trial being conducted?
This trial is being conducted at Phoenix, United States, San Diego, United States, Minneapolis, United States, Charleston, United States.
Who is sponsoring the NCT06990191 clinical trial?
NCT06990191 is sponsored by United States Department of Defense. The principal investigator is Laura Meis, PhD at University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System. The trial plans to enroll 420 participants.