Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Change from baseline in the measure of the Sleep Diary
研究概览
简要总结
The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.
详细描述
This randomized study investigates whether two treatment conditions:Mind-Body Bridging (MBB) and Supportive Education (SED) are effective in improving sleep disturbance and self-reported indicators of other co-morbid symptoms in veterans with GWI. The two treatment conditions will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).
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
- 38 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran from First Gulf War
- •Suffering from sleep disturbance
- •Has other chronic symptoms of Gulf War Illness:
- •chronic headaches
- •joint/muscle pain
- •cognitive difficulties
- •memory/concentration problems
- •shortness of breath
- •gastrointestinal symptoms
排除标准
- •terminally ill
- •a highly unstable medical or psychiatric condition
- •Parkinson disease
- •dementia of any cause
- •delayed/advanced sleep phase syndrome
- •Narcolepsy
结局指标
主要结局
Change from baseline in the measure of the Sleep Diary
时间窗: Week2, Week 4, Week 15
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
时间窗: Week1, Week2, Week 3, Week 4, Week 15
次要结局
- Pain(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- Fatigue(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- Cognitive functioning(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- Mindfulness(Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15))
- Health-related quality of life(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- Depression(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- Psychological symptoms(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- PTSD(Pre (Baseline), Post (Week4), Follow-up (Week 15))
研究者
Yoshio Nakamura
Research Associate Professor
University of Utah