A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD

Recruiting now · Not applicable

Conditions studied: Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT06990191

Run by

United States Department of Defense

People needed

420

Starts

2025-05-16

Expected to finish

2028-08-31

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• San Diego VA Healthcare System — San Diego, California, United States (enrolling)
• Phoenix VA Healthcare System — Phoenix, Arizona, United States
• Minneapolis VA Healthcare System — Minneapolis, Minnesota, United States
• Charleston VA Healthcare System — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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