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
- 2
- 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
研究组 & 干预措施
Mind-Body Bridging Program
The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
干预措施: Mind-Body Bridging Program (Behavioral)
Supportive Education
Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.
干预措施: Supportive Education (Behavioral)
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