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

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.

Conditions

• Post Traumatic Stress Disorder

Interventions

BEHAVIORAL

Partnered 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.

BEHAVIORAL

Prolonged 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.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Center for Veterans Research and Education

  collaborator OTHER

• Arizona Veterans Research and Education Foundation

  collaborator UNKNOWN

• Lowcountry Center for Veterans Research

  collaborator UNKNOWN

• Veterans Medical Research Foundation

  collaborator OTHER

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• VA Palo Alto Health Care System

  collaborator FED

• Atlanta VA Medical Center

  collaborator FED

• Tampa VA Healthcare System

  collaborator UNKNOWN

• San Diego Veterans Healthcare System

  collaborator FED

• Charleston VA Healthcare System

  collaborator UNKNOWN

• Phoenix VA Health Care System

  collaborator FED

• United States Department of Defense

  lead FED

Principal Investigators

• Laura Meis, PhD · University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System

• Leslie Morland, PhD · National Center for PTSD; San Diego VA Healthcare System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-16

Primary Completion

2028-08-31

Completion

2028-08-31

Countries

• United States

Study Locations