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

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ClinicalTrials.gov Identifier: NCT01022203
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : March 9, 2015
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Stress Disorders, Post-Traumatic Behavioral: Structured Approach Therapy Other: PTSD Family Education

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Couples Treatment of PTSD in OEF/OIF Veterans
Study Start Date : August 2010
Primary Completion Date : December 2013
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022203

United States, Louisiana
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
VA Office of Research and Development
Southeast Louisiana Veterans Health Care System
Principal Investigator: Frederic J Sautter, PhD Southeast Louisiana Veterans Health Care System, New Orleans, LA
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022203     History of Changes
Other Study ID Numbers: B6756-R
First Posted: December 1, 2009    Key Record Dates
Results First Posted: March 9, 2015
Last Update Posted: November 16, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Couples Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders