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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
Sponsor:
Collaborator:
Southeast Louisiana Veterans Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE November 25, 2009
First Posted Date  ICMJE December 1, 2009
Results First Submitted Date  ICMJE December 12, 2014
Results First Posted Date  ICMJE March 9, 2015
Last Update Posted Date November 16, 2016
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Psychological Functioning [ Time Frame: Pre-treatment, post-treatment, 12-week follow-up. ]
Change History Complete list of historical versions of study NCT01022203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • Marital Functioning [ Time Frame: Pre-treatment, post-treatment, 12-week follow-up. ]
  • Community functioning. [ Time Frame: Pre-treatment, post-treatment, 12-week follow-up. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education
Official Title  ICMJE Couples Treatment of PTSD in OEF/OIF Veterans
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Structured Approach Therapy
    Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.
    Intervention: Behavioral: Structured Approach Therapy
  • Active Comparator: PTSD Family Education
    Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.
    Intervention: Other: PTSD Family Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2015)
138
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
130
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022203
Other Study ID Numbers  ICMJE B6756-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Southeast Louisiana Veterans Health Care System
Investigators  ICMJE
Principal Investigator: Frederic J Sautter, PhD Southeast Louisiana Veterans Health Care System, New Orleans, LA
PRS Account VA Office of Research and Development
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP