Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Structured Clinical Interview for DSM IV: Mood and PTSD modules
研究概览
简要总结
The purpose of this study is to determine whether a newly developed, brief cognitive behavioral intervention, relative to supportive counseling, is effective in reducing acute stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.
详细描述
Importance: Burns are painful, life threatening and disfiguring. Severe psychological distress, pain and sleep disturbance are among the most common, enduring and disabling of secondary complications, however, no evidence based treatments exists for these complex problems in the acute burn care setting.
Design: Randomized, controlled effectiveness trial, group assignment blinded to baseline status, groups stratified by history of pre-existing psychiatric disorder.
Objectives. To develop the Safety, Meaning, Activation and Resilience Training (SMART) protocol; To evaluate its short and long-term effectiveness, relative to viable placebo, Supportive Counseling (SC), in improving key dependent measures (e.g., ASD, PTSD), mediators, and, enhancing health and function outcomes.
Setting: A leading edge, State-dedicated, regional burn center in a major, metropolitan teaching hospital serving diverse residents from large urban settings, small towns and remote rural areas.
Interventions: SMART (focused cognitive-behavioral therapy with training in anxiety management, and treatment with prolonged exposure and cognitive restructuring) will be contrasted with SC (non-directive empathy, warmth, positive regard).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •18 to 70 years old
- •acute burn injury
- •exceeding criteria on screening instrument at baseline (in-hospital prior to treatment): Acute Stress Disorder Scale (ASDS score ≥ 37: acute posttrauma distress).
排除标准
- •Age less than 18 or greater than 70 years
- •Presence of a significant cognitive / neurological or psychiatric condition precluding informed consent (e.g., psychosis, acute suicidality)
- •Inability to communicate in English
- •intubated or sedated
研究组 & 干预措施
Cognitive Behavioral Therapy
干预措施: Cognitive Behavioral Therapy (Behavioral)
Supportive Counseling
干预措施: Supportive Counseling (Behavioral)
结局指标
主要结局
Structured Clinical Interview for DSM IV: Mood and PTSD modules
时间窗: 1 week, 1 month and 6 months post-treatment
次要结局
- Patient Health Questionnaire - 9 (depression)(1 week, 1 month and 6 months post-treatment)
- Davidson Trauma Scale(1 week, 1 month and 6 months post-treatment)
- Insomnia Severity Index(1 week, 1 month and 6 months post-treatment)
- McGill pain Questionnaire(1 week, 1 month and 6 months post-treatment)
- Post Traumatic Growth Inventory(1 week, 1 month and 6 months post-treatment)