CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
CBCT for PTSD +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02336971
NCT02336971Phase 3Completed

Individual Prolonged Exposure (PE) Versus Couples' Cognitive-Behavioral Therapy for Combat-Related Posttraumatic Stress Disorder (PTSD)

Toronto Metropolitan University·interventional·Posted Jan 13, 2015·Updated Oct 7, 2016

In Brief

A Phase 3 clinical trial evaluating CBCT for PTSD and Prolonged Exposure for PTSD and Marital Relationship. Completed, enrolled 64 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2015
Enrollment StartNov 1, 2011
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.5 years ago

Interventions

CBCT for PTSDbehavioral

CBCT consists of three phases of treatment: Phase 1: treatment orientation and education about PTSD and its related intimate relationship problems Phase 2: behavioral communication skills training Phase 3: cognitive interventions based on Cognitive Processing Therapy (CPT)

Prolonged Exposurebehavioral

PE consists of: psychoeducation and some limited distress management training, but emphasizes the role of imaginal and in vivo exposure in treating PTSD.