Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education
Couples Treatment of PTSD in OEF/OIF Veterans
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedResults Posted
Study results publicly available
March 9, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 16, 2016
October 1, 2016
3.3 years
November 25, 2009
December 12, 2014
October 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychological Functioning
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 Outcomes (2)
Relationship Functioning
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Emotion Regulation
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Study Arms (2)
Structured Approach Therapy
EXPERIMENTALCouple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.
PTSD Family Education
ACTIVE COMPARATORCouple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70112, United States
Related Publications (2)
Sautter FJ, Glynn SM, Cretu JB, Senturk D, Vaught AS. Efficacy of structured approach therapy in reducing PTSD in returning veterans: A randomized clinical trial. Psychol Serv. 2015 Aug;12(3):199-212. doi: 10.1037/ser0000032.
PMID: 26213789RESULTSautter FJ, Glynn SM, Becker-Cretu JJ, Senturk D, Armelie AP, Wielt DB. Structured Approach Therapy for Combat-Related PTSD in Returning U.S. Veterans: Complementary Mediation by Changes in Emotion Functioning. J Trauma Stress. 2016 Aug;29(4):384-7. doi: 10.1002/jts.22120. Epub 2016 Jul 29.
PMID: 27472747RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study's small sample size makes results preliminary and precludes formal hypothesis testing of mediating variables. Our report of decreased PTSD may reflect regression toward the mean.
Results Point of Contact
- Title
- Frederic Sautter, Ph.D.
- Organization
- Southeast Louisiana Veterans Health Care System (SLVHCS)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic J Sautter, PhD
Southeast Louisiana Veterans Health Care System, New Orleans, LA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2009
First Posted
December 1, 2009
Study Start
August 1, 2010
Primary Completion
December 1, 2013
Study Completion
October 1, 2016
Last Updated
November 16, 2016
Results First Posted
March 9, 2015
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share