Recruiting

Partner-Assisted Prolonged Exposure

Sponsor:

United States Department of Defense

Code:

NCT06990191

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Partnered Prolonged Exposure (PPE)

Prolonged Exposure (PE)

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT06990191

Start date

May 16, 2025

Status verified date

May, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Prolonged Exposure (PE)

experimental: Partnered Prolonged Exposure (PPE)

Interventions

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.

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.

Primary outcome measure

  • Inventory of Psychosocial Functioning (IPF) [ Time Frame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. ]

Central Contacts and Locations

Central contacts

Locations

San Diego VA Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Principal Investigator:

Alejandra Infante

More Information

Sponsor

United States Department of Defense

Last update posted

Nov 14, 2025

Last verified

May, 2025

Keywords

  • Trauma-focused therapies
  • Prolonged exposure
  • Veterans
  • Integrative Behavioral Couples Therapy
  • couples
  • PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Department of Defense on 2025-11-14.