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
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Structured Approach Therapy Other: PTSD Family Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Couples Treatment of PTSD in OEF/OIF Veterans|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||October 2016|
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.
- 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).
- 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).
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|
|Principal Investigator:||Frederic J Sautter, PhD||Southeast Louisiana Veterans Health Care System, New Orleans, LA|