Individual PE vs Couples' CBT for Combat-Related Posttraumatic Stress Disorder

Completed · Phase 3

Conditions studied: PTSD, Marital Relationship

In brief

This study seeks to enroll 76 couples in which one of the members is a combat-veteran with PTSD. Each couple will be randomized into one of two cognitive-behavioral therapies developed specifically as a treatment for PTSD-either Prolonged Exposure (PE) \[1-4\] or Cognitive-Behavioral Couples Therapy (CBCT) \[5-7\]. Whereas, PE was developed as a one-on-one therapy that focuses on treating the individual, CBCT for PTSD incorporates the partners into therapy and seeks to directly address relationship functioning while treating the PTSD symptomatology. Both partners in each couple will complete a battery of several assessments measuring various aspects of psychological distress (e.g., depression, PTSD) and relationship functioning at five time-points throughout the study. But, only the partners assigned to the CBCT group will be involved in the actual therapy sessions. Analysis will be carried out to identify whether any significant differences exist between PE and CBCT in treating PTSD and improving relationship functioning.

Key facts

Study ID

NCT02336971

Run by

Toronto Metropolitan University

People needed

64

Starts

2011-11-01

Expected to finish

2016-08-01

Last updated by the study team

2016-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Married or cohabitating couples who have been together the past 3 months in which one partner is an OEF/OIF/OND veteran with PTSD. Diagnosis of PTSD will be determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The veteran with PTSD must have experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of OIF/OEF/OND. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
• Both individuals must be willing to make a commitment to treatment as prescribed by their randomization in this study.
• Speak and read English.
• Be stable for at least 6 weeks on any psychotropic medications either partner may be taking. This criterion is established in order to minimize the likelihood that significant outcome effects may be attributed to changes in psychotropic medications rather than to the treatment protocol.

You may not qualify if…

• • Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question screen for severe violence items by either member of the couple occurring within the past 6-months.
• Partner with PTSD symptoms on the Life Events Checklist (LEC), Deployment Risk and Resilience Inventory (DRRI) subscales (if active duty and is a Veteran of deployment), and PTSD CheckList - Stressor Specific (PCL-S) warranting primary treatment for him or herself.
• Recent initiation of other treatment (i.e., drug/alcohol treatment) or an identified immediate need for other treatment (i.e., severe suicide risk, current alcohol dependence).
• Current suicidal ideation severe enough to warrant immediate attention (as determined by the Scale for Suicidal Ideation)
• Alcohol dependence as assessed using the Alcohol Use Disorders Identification Test (AUDIT).
• Any severe cognitive impairment that precludes retention of session content across sessions or an ongoing psychotic or bipolar disorder.

Where it is running

• Fort Hood Military Base — Fort Hood, Texas, United States
• Brooke Army Medical Center, Fort Sam Houston — Fort Sam Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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