About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Post-9/11 Veteran Enrolled in VHA
1 > mo stable medication
Committed relationship 6+ months
DSM-5-R PTSD Diagnosis
Disqualifiers
Imminent suicidality/homicidally
Mania, psychosis, or severe substance use disorder, past 3 mos
Severe cognitive impairment
Severe intimate partner violence in last 6 months
Trial design
Parallel
Treatments tested in this trial
Partnered Prolonged Exposure (PPE)
BehavioralThe 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)
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Gold standard, structured-clinical interview that assesses PTSD symptom severity.
PTSD Checklist for DSM-5 (PCL-5)
Self-report instrument that measures PTSD symptom severity.
Patient Health Questionnaire - 9 (PHQ-9)
Self-report instrument that measures depression severity
Other outcomes
Couples satisfaction index
Self-report instrument that measures romantic relationship satisfaction
Perceived Stress Scale
Self-report instrument that measures perceived stress.
Short Zarit Burden Interview
Self-report instrument that measures caregiver burden.
WHO Disability Assessment Schedule (WHO-DAS 2.0)
Self-report instrument that measures psychosocial functioning.
Sponsors and contacts
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United States Department of Defense
Lead sponsor
University of Minnesota
Sponsor institution
University of Minnesota
Collaborator
Center for Veterans Research and Education
Collaborator
Arizona Veterans Research and Education Foundation
Collaborator
Lowcountry Center for Veterans Research
Collaborator
Veterans Medical Research Foundation
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
VA Palo Alto Health Care System
Collaborator
Atlanta VA Medical Center
Collaborator
Tampa VA Healthcare System
Collaborator
San Diego Veterans Healthcare System
Collaborator
Charleston VA Healthcare System
Collaborator
Phoenix VA Health Care System
Collaborator