Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06990191

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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