A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
COOPERATE
1 other identifier
interventional
420
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
November 14, 2025
May 1, 2025
3.3 years
April 29, 2025
November 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inventory of Psychosocial Functioning (IPF)
The primary outcome is Veterans' global functioning at posttreatment assessment. The subdimensions of global functioning that matter most to Veterans with PTSD are their relationships with intimate partners, family relationships, work performance, friend relationships, parenting, educational performance, and self-care functioning (e.g., maintaining personal hygiene, exercising, household chores, healthy eating). Outcomes will be measured using the Inventory of Psychosocial Functioning (IPF).
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Secondary Outcomes (3)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Baseline, posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. follow-up, 6 month follow-up
PTSD Checklist for DSM-5 (PCL-5)
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Patient Health Questionnaire - 9 (PHQ-9)
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Other Outcomes (5)
Couples satisfaction index
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Perceived Stress Scale
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Short Zarit Burden Interview
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
- +2 more other outcomes
Study Arms (2)
Prolonged Exposure (PE)
ACTIVE COMPARATORPartnered Prolonged Exposure (PPE)
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Post-9/11 Veteran Enrolled in VHA
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United States Department of Defenselead
- University of Minnesotacollaborator
- Center for Veterans Research and Educationcollaborator
- Arizona Veterans Research and Education Foundationcollaborator
- Lowcountry Center for Veterans Researchcollaborator
- Veterans Medical Research Foundationcollaborator
- Minneapolis Veterans Affairs Medical Centercollaborator
- VA Palo Alto Health Care Systemcollaborator
- Atlanta VA Medical Centercollaborator
- Tampa VA Healthcare Systemcollaborator
- San Diego Veterans Healthcare Systemcollaborator
- Charleston VA Healthcare Systemcollaborator
- Phoenix VA Health Care Systemcollaborator
Study Sites (4)
Phoenix VA Healthcare System
Phoenix, Arizona, 85012, United States
San Diego VA Healthcare System
San Diego, California, 92161, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, 55417, United States
Charleston VA Healthcare System
Charleston, South Carolina, 29401, United States
Related Publications (7)
Cusack K, Jonas DE, Forneris CA, Wines C, Sonis J, Middleton JC, Feltner C, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis. Clin Psychol Rev. 2016 Feb;43:128-41. doi: 10.1016/j.cpr.2015.10.003. Epub 2015 Nov 2.
PMID: 26574151BACKGROUNDSteenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
PMID: 26241600BACKGROUNDBradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.
PMID: 15677582BACKGROUNDTaft CT, Watkins LE, Stafford J, Street AE, Monson CM. Posttraumatic stress disorder and intimate relationship problems: a meta-analysis. J Consult Clin Psychol. 2011 Feb;79(1):22-33. doi: 10.1037/a0022196.
PMID: 21261431BACKGROUNDJakupcak M, Cook J, Imel Z, Fontana A, Rosenheck R, McFall M. Posttraumatic stress disorder as a risk factor for suicidal ideation in Iraq and Afghanistan War veterans. J Trauma Stress. 2009 Aug;22(4):303-6. doi: 10.1002/jts.20423.
PMID: 19626682BACKGROUNDKessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.
PMID: 10761674BACKGROUNDRichardson LK, Frueh BC, Acierno R. Prevalence estimates of combat-related post-traumatic stress disorder: critical review. Aust N Z J Psychiatry. 2010 Jan;44(1):4-19. doi: 10.3109/00048670903393597.
PMID: 20073563BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Meis, PhD
University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System
- PRINCIPAL INVESTIGATOR
Leslie Morland, PhD
National Center for PTSD; San Diego VA Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 25, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
November 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Deidentified datasets will be made available following study completion.
In accordance with 38 USC 7332, this type of information will be kept confidential and will not be disclosed in presentations, publications, or any other dissemination of the study results, or to anyone outside of the IRB-approved study team. Deidentified datasets will be made available following study completion. Participants will be notified of this during informed consent.