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

Not Applicable

Completed

Conditions: Stress Disorders, Post-Traumatic

Interventions: Behavioral: Structured Approach Therapy
Other: PTSD Family Education

Registration Number: NCT01022203

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 138

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured Approach Therapy	Structured Approach Therapy	Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.
PTSD Family Education	PTSD Family Education	Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.

Primary Outcome Measures

Name	Time	Method
Psychological Functioning	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).

Secondary Outcome Measures

Name	Time	Method
Relationship Functioning	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	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).