Overview

This trial is active, not recruiting.

Condition stress disorders, post-traumatic
Treatments structured approach therapy, ptsd family education
Sponsor Department of Veterans Affairs
Start date August 2010
End date December 2013
Trial size 69 participants
Trial identifier NCT01022203, B6756-R

Summary

The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD, called Structured Approach Therapy, to decrease PTSD and improve the marital and social functioning of OIF/OEF veterans. The effectiveness of couples therapy will be compared with the effectiveness of an educational intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Couple's Therapy Intervention
structured approach therapy
Couple's Therapy for PTSD
(Active Comparator)
Educational Intervention.
ptsd family education
Education about PTSD for couples.

Primary Outcomes

Measure
Psychological functioning
time frame: Pre-treatment, post-treatment, 12-week follow-up.

Secondary Outcomes

Measure
Marital Functioning
time frame: Pre-treatment, post-treatment, 12-week follow-up.
Emotion Regulation
time frame: Pre-treatment, post-treatment, 12-week follow-up.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Exposure to at least one combat-related Criterion A stressful event during OEF/OIF deployment, - Current DSM-IVR criteria for PTSD for that event, and - Veteran is in a committed relationship and living with an opposite sex partner for at least six months. Exclusion Criteria: - Current psychotic symptoms in either partner, - Current diagnosis of alcohol or drug dependence in either partner, - History of recurrent physical assault/abuse as indicated by responses to the Conflict Tactics Scale, - Currently receiving an evidence-based PTSD treatment (exposure-based therapy, CBT), and - Currently receiving couples therapy or family therapy

Additional Information

Official title Couples Treatment of PTSD in OEF/OIF Veterans
Principal investigator Frederick Sautter, PhD
Description The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy (SAT), by randomly assigning 60 OEF/OIF veterans and their partners to either a 12-15 session SAT program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two treatment conditions will be ascertained by obtaining measures of PTSD severity, relationship functioning, and emotion regulation prior to treatment, immediately after treatment, and three months after the last treatment session. We will test the hypothesis that couples participating in SAT will show significantly greater improvements on measures from all three outcome domains. These hypotheses will be tested by using mixed effects repeated measures analyses to compare mean scale scores from the respective outcome measures across the two treatment groups (SAT, Education), over successive time periods (pre-test, post-test, 12 week follow- up. The objectives of the intervention are to decrease PTSD severity, improve relationship and family functioning, and decrease problems in emotion regulation, in a group of young veterans at risk for developing chronic PTSD, and to reduce emotional distress and relationship and family problems in their spouses.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.