Clinical trial NCT01022203: Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education
Official title: Couples Treatment of PTSD in OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Couples Therapy
PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Southeast Louisiana Veterans Health Care System
First posted: 2009-12-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological Functioning
timeFrame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Secondary outcomes:
measure: Relationship Functioning
timeFrame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
measure: Emotion Regulation
timeFrame: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System, New Orleans, LA
state: Louisiana
Study officials:
affiliation: Southeast Louisiana Veterans Health Care System, New Orleans, LA
name: Frederic J Sautter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.