RecruitingNot ApplicableNCT06990191

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


Sponsor

United States Department of Defense

Enrollment

420 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a couples-based therapy approach for helping veterans with PTSD — specifically a therapy where the veteran's partner is involved in the treatment sessions. **You may be eligible if...** - You are a post-9/11 veteran enrolled in the VA healthcare system - You have a confirmed PTSD diagnosis - You have been in a committed relationship for at least 6 months - Your medications have been stable for at least 1 month **You may NOT be eligible if...** - You are at immediate risk of harming yourself or others - You have severe mania, psychosis, or substance use disorder in the past 3 months - You have severe cognitive impairment - There is severe violence in your relationship, or you feel unsafe around your partner - Your partner has their own active PTSD diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALPartnered Prolonged Exposure (PPE)

The PPE condition adapts the PE protocol with strategies from Integrative Behavioral Couples Therapy (an evidence-based couple therapy. PPE involves twice-weekly 60-minute sessions, with some sessions completed by both the Veteran and their partner while others are with the Veteran only.

BEHAVIORALProlonged Exposure (PE)

The PE condition will follow the standardized PE manual and involve weekly 90-minute sessions and a 30-minute check-in attended only by the Veteran and the therapist.


Locations(4)

Phoenix VA Healthcare System

Phoenix, Arizona, United States

San Diego VA Healthcare System

San Diego, California, United States

Minneapolis VA Healthcare System

Minneapolis, Minnesota, United States

Charleston VA Healthcare System

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06990191


Related Trials