- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01022203
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
-
-
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.
|
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.
|
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.
Collaborators
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
- 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.
- Sautter 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.
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.
Clinical Trials on Stress Disorders, Post-Traumatic
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
US Department of Veterans AffairsEmory UniversityWithdrawnPost-Traumatic Stress Disorders
-
University of KonstanzGerman Research Foundation; NGO vivo e.V.; GTZ-German Technical Cooperation,... and other collaboratorsCompletedPost-Traumatic Stress DisordersSri Lanka
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
-
Johns Hopkins UniversityWithdrawnPost-Traumatic Stress Disorder
Clinical Trials on Structured Approach Therapy
-
University of California, Los AngelesVA Greater Los Angeles Healthcare SystemWithdrawnPTSD | Recent Era Combat Veteran | Couples CommunicationUnited States
-
Universitair Ziekenhuis BrusselEnrolling by invitationEnteral Nutrition | Parenteral Nutrition | Tube Feeding | Oral AversionBelgium
-
Copenhagen Academy for Medical Education and SimulationUniversity of CopenhagenActive, not recruiting
-
University of TennesseeWithdrawnOccupational/Physical Therapy | Post-operative Breast ReconstructionUnited States
-
Beijing Anzhen HospitalNot yet recruitingHypertension | Medication Therapy ManagementChina
-
Gruppo Italiano Malattie EMatologiche dell'AdultoUnknown
-
Lev-Hasharon Mental Healtlh CenterUnknownBipolar Affective DisorderIsrael
-
Philipps University Marburg Medical CenterCompleted
-
Joslin Diabetes CenterMetagenics, Inc.CompletedObesity | Type 2 DiabetesUnited States
-
Riphah International UniversityCompleted