Couples Treatment of PTSD in OEF/OIF Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Psychological Functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Psychological Functioning
时间窗: 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).
次要结局
- Relationship Functioning(Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).)
- Emotion Regulation(Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).)