A Pilot Study of Two Contrasting Intervention Programs for Sleep Management - Part II
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Medical Outcomes Study-Sleep Scale
研究概览
简要总结
The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a randomized clinical trial that compares the effects of a mind-body bridging program with a sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances. In Part II of the study, the investigators will perform a six month follow-up on the same subjects.
详细描述
In this follow-up, we ask subjects to answer the same questionnaires that they completed at the beginning of the study. In addition we will ask subjects to complete a survey reflecting their medical history over the past 6 months and a second survey establishing their behavioral patterns and whether they continued practicing techniques of the intervention they were assigned to.
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 (Participant)
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
- 是
入选标准
- •Have participated in Part I of this study
排除标准
- •The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.
研究组 & 干预措施
Mind-Body Bridging Program
Mind Body Bridging subjects will be accessed with questionnaires and medical history evaluations for the impact of MBBP over the past 6 months since undertaking the program.
干预措施: Mind-Body Bridging Program (Behavioral)
Sleep Hygiene
Sleep Hygiene subjects will be accessed with questionnaires and medical history evaluations for the impact of SH over the past 6 months since undertaking the program.
干预措施: Sleep Hygiene (Behavioral)
结局指标
主要结局
Medical Outcomes Study-Sleep Scale
时间窗: 6 months following study part I
Medical Outcomes Study Short Form-36
时间窗: 6 months following study part I
次要结局
- Five-factor Mindfulness Questionnaire(6 months following study part I)
- PTSD Check List-Military(6 months following study part I)
- Center for Epidemiologic Studies Depression Scale(6 months following study part I)