Effectiveness of Ba Duan Jin Exercise on Chronic Insomnia (CI) With Hyperarousal/Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of Ba Duan Jin exercise in treating chronic insomnia (CI) with comorbid hyperarousal and anxiety symptoms.
详细描述
Chronic Insomnia (CI) is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep, leading to significant daytime dysfunction. Many CI patients experience hyperarousal, both physiological and psychological, commonly manifested as anxiety, which further exacerbates sleep disturbances and reduces quality of life.
While pharmacotherapy and cognitive behavioral therapy (CBT) are effective for some patients, they are limited by side effects, costs, and accessibility. Traditional mind-body practices such as Ba Duan Jin, a classic Chinese Qigong exercise, have been explored as alternative therapies to improve sleep quality and alleviate anxiety symptoms.
Ba Duan Jin consists of a sequence of gentle and flowing movements designed to promote physical and mental relaxation. Preliminary studies suggest that mind-body exercises like Ba Duan Jin can positively influence sleep patterns, psychological well-being, and overall health.
This randomized controlled trial will recruit 84 participants diagnosed with CI and comorbid hyperarousal/anxiety symptoms. Participants will be randomly assigned to either a Ba Duan Jin plus Sleep Hygiene Education (SHE) group or an SHE-only group.
The intervention will last for 6 weeks, with participants in the Ba Duan Jin group practicing once daily for 50 minutes.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Insomnia Disorder according to DSM-5 criteria.
- •Pittsburgh Sleep Quality Index (PSQI) total score >
- •Age ≥ 8 years.
- •Educational level of at least junior high school.
- •Voluntarily agree to participate and sign informed consent.
- •Presence of anxiety symptoms, defined as a Hamilton Anxiety Rating Scale (HAMA-14) score ≥ 14.
排除标准
- •Presence of severe physical illnesses or major psychiatric disorders, or assessed to be at risk of suicide.
- •Diagnosis or suspicion of sleep breathing disorder, restless legs syndrome, circadian rhythm sleep disorder, or engaged in night-shift work.
- •Pregnancy or breastfeeding.
- •Currently undergoing any form of psychological therapy.
结局指标
主要结局
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
时间窗: Baseline, 6 weeks
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
次要结局
- The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months(Baseline, 3 months, 6 months, 12 months)
- The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Scores(Baseline, Week 6, 3 months, 6 months, and 12 months)
- The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)