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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Southeast Louisiana Veterans Health Care System
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01022203
First received: November 25, 2009
Last updated: February 23, 2015
Last verified: February 2015
  Purpose

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 Intervention
Stress Disorders, Post-Traumatic
Behavioral: Structured Approach Therapy
Other: PTSD Family Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Couples Treatment of PTSD in OEF/OIF Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Psychological Functioning [ Time Frame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). ] [ Designated as safety issue: No ]
    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:
  • Relationship Functioning [ Time Frame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). ] [ Designated as safety issue: No ]
    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.

  • Emotion Regulation [ Time Frame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). ] [ Designated as safety issue: No ]
    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).


Enrollment: 138
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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. We 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022203

Locations
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Southeast Louisiana Veterans Health Care System
Investigators
Principal Investigator: Frederic Sautter, PhD Southeast Veterans Healthcare System, New Orleans
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01022203     History of Changes
Other Study ID Numbers: B6756-R
Study First Received: November 25, 2009
Results First Received: December 12, 2014
Last Updated: February 23, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Couples Therapy
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on March 31, 2015