Comparative Effectiveness of the Mahayana Buddhist Awareness Training Program and Qigong Intervention on the Psychological and Neurological Outcomes for People With Insomnia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index
研究概览
简要总结
This study aims to compare the efficacy of the Mahayana Buddhist Awareness Training Program (ATP) with a Qigong group in treating people with insomnia in Hong Kong. It also aims to investigate the underlying mechanisms, including changes in brain activity and heart rate variability during wakefulness, through which these two Eastern mind body interventions improve sleep quality. It is expected that ATP will be as efficacious as Qigong in enhancing sleep quality. Compared to the Qigong intervention, the more mind-based ATP will lead to more improvement in mental health and greater reductions in hyperarousal brain activity. Compared to ATP, the more body-based Qigong will lead to greater improvement in physical health and heart rate variability.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) being a resident of Hong Kong;
- •(2) age between 50 and 75 years old;
- •(3) possessing the ability to read and write in Chinese;
- •(4) obtaining a Pittsburgh Sleep Quality Index (PSQI) score > 5 at baseline
- •(5) demonstrating willingness to provide informed consent and adherence to study protocol.
排除标准
- •(1) Beck Depression Inventory-II suicidal ideation score >= 2;
- •(2) current use of hypnotic medications or any prescription medications that may influence sleep;
- •(3) necessity to take such medications during the trial period;
- •(4) ongoing therapies or clinical trials for insomnia;
- •(5) intention to undergo such clinical interventions during the trial period;
- •(6) working in shifts;
- •(7) engagement in considerable mindfulness practices exceeding 15 minutes per day;
- •(8) regular participation in different forms of Qigong, aerobics, yoga, Tai Chi, or martial arts practice at least once a week in the past six months;
- •(9) limited mobility or health conditions that hinder the performance of specific Qigong movements;
- •(10) currently receiving psychological, psychiatric or counselling services at least once a month;
- •(11) having been diagnosed with schizophrenia or psychosis by a clinician;
- •(12) having an active metal implant, pacemaker, or defibrillator in the body that affects objective assessment;
- •(13) impaired skin integrity or allergies to electrode gel or adhesive at the wearable EEG device placement site;
- •(14) pregnancy
研究组 & 干预措施
Mahayana Buddhist Awareness Training Program (ATP)
The 8-session ATP intervention consists of six 3-hour workshops plus two full day retreats. It will be delivered by instructors, who are trained by ATP co-founders. Participants will be guided to cultivate wisdom of non-attachment and compassion progressively by learning, contemplation, and practice. They will learn and memorize a core Buddhist mantra "Om mani padme hum," attend lectures, practice meditation, participate in experiential and reflective learning activities, and join the group discussions. Each workshop will typically begin with a sharing session followed by a Q&A segment to address participants' questions and concerns. To deepen their learning experience, revision exercises and corrections to revision exercises will be embedded at the end of each workshop. Participants will also receive guided meditation audio tracks, handouts, and weekly homework assignment to support their practice outside of workshop sessions.
干预措施: Psychosocial intervention (Behavioral)
Qigong Intervention
The 8-session Qigong intervention, with reference to the Five Elements Balance Qigong, will be delivered by instructors, who are trained by an experienced Daoist Qigong master teacher. It consists of six-3 hour workshops plus two full day retreats. Each workshop will typically begin with an introduction to some basic Traditional Chinese Medicine and Qigong concepts, or precautions in doing Qigong exercises and addressing participants' inquiries. Participants will progressively learn ten forms of simple Qigong movements that aim to enhance the flow of qi .The participants will also be asked to practice Qigong at home for 30 minutes at least three times per week and complete a practice log. Participants will also receive handouts to support their learning after each session.
干预措施: Psychosocial intervention (Behavioral)
结局指标
主要结局
Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index
时间窗: Baseline, immediately after the intervention, 7 weeks after the intervention
It measures sleep quality and disturbances experienced within a 1-month time frame. Scores range from 0 to 21, where a higher score represents poorer sleep quality.
Changes over the measurement points in the brain activity during wakefulness
时间窗: Baseline, immediately after the intervention, 7 weeks after the intervention
Spectral power analysis for participants' theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-50 Hz) bands during a 10-minute resting state wakefulness will be measured by the UMindSleep device (http://www.eegsmart.com/en/UMindSleep.html).
Changes over the measurement points in the heart rate variability
时间窗: Baseline, immediately after the intervention, 7 weeks after the intervention
This will be measured by the same wearable UMindSleep device.
次要结局
- Changes over the measurement points in the 6-item Qi Deficiency Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the 7-item Insomnia Severity Index(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the 16-item Pre-Sleep Arousal Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the 5-item item Santa Clara Brief Compassion Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the PROMIS® 2-item Global Physical Health-2 Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the PROMIS® 2-item Global Mental Health-2 Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the 6-item Qi Stagnation Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the 2-item Generalized Anxiety Disorder-2 Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)
- Changes over the measurement points in the 2-item Patient Health Questionnaire-2 Scale(Baseline, immediately after the intervention, 7 weeks after the intervention)