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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnited States Department of Defense

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Partnered Prolonged Exposure (PPE)

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Prolonged Exposure (PE)Active comparator 1 intervention
Group B: Partnered Prolonged Exposure (PPE)Experimental treatment 1 intervention

Trial outcomes

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).

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.

Secondary outcomes

1

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Gold standard, structured-clinical interview that assesses PTSD symptom severity.

Time frame
Baseline, posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. follow-up, 6 month follow-up
2

PTSD Checklist for DSM-5 (PCL-5)

Self-report instrument that measures PTSD symptom severity.

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
3

Patient Health Questionnaire - 9 (PHQ-9)

Self-report instrument that measures depression severity

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.

Other outcomes

1

Couples satisfaction index

Self-report instrument that measures romantic relationship satisfaction

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
2

Perceived Stress Scale

Self-report instrument that measures perceived stress.

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
3

Short Zarit Burden Interview

Self-report instrument that measures caregiver burden.

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
4

WHO Disability Assessment Schedule (WHO-DAS 2.0)

Self-report instrument that measures psychosocial functioning.

Time frame
Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.

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