Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education

October 5, 2016 updated by: VA Office of Research and Development

Couples Treatment of PTSD in OEF/OIF Veterans

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 Iraqi war Veterans and their partners. The effectiveness of couples therapy will be compared with the effectiveness of a couple-based educational intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy, by randomly assigning 57 Iraqi war Veterans and their partners to either a 12-15 session Structured Approach Therapy program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two experimental conditions will be ascertained by obtaining measures of PTSD severity from Veterans and measures of relationship functioning and emotion regulation from Veterans and their partners prior to treatment, immediately after treatment, and three months after the last treatment session. The investigators will test the hypothesis that couples participating in Structured Approach Therapy will show significantly greater improvements on all three clinical outcome measures than couples participating in PTSD Family Education. These hypotheses will be tested with an intent-to-treat analysis using general linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcome, separately for the Veterans and their partners. The objectives of the Structured Approach Therapy 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 partners.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Southeast Louisiana Veterans Health Care System, New Orleans, LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Exposure to at least one combat-related stressful event during combat deployment,
  • Current diagnostic 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 recent physical assault/abuse,
  • Currently receiving an evidence-based PTSD treatment (exposure-based or cognitive processing therapy)
  • Currently receiving couples therapy or family therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Structured Approach Therapy
Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.
Behavioral: Structured Approach Therapy
The Structured Approach Therapy intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach Veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication.
ACTIVE_COMPARATOR: PTSD Family Education
Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.
Other: PTSD Family Education
The PTSD Family Education intervention provides education for Veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Functioning
Time Frame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship Functioning
Time Frame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Emotion Regulation
Time Frame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Southeast Louisiana Veterans Health Care System

Investigators

  • Principal Investigator: Frederic J Sautter, PhD, Southeast Louisiana Veterans Health Care System, New Orleans, LA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (ESTIMATE)

December 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B6756-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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