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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Couples Treatment of PTSD in OEF/OIF Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01022203
• Other study ID #: B6756-R
• Status: Active, not recruiting
• Phase: N/A
• First received: November 25, 2009
• Last updated: February 10, 2016
• Start date: August 2010
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: May 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Southeast Louisiana Veterans Health Care System, New Orleans, LA	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Southeast Louisiana Veterans Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	Relationship Functioning	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).	No
Secondary	Emotion Regulation	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).	No