Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia (NCT06910423) | Clinical Trial Compass
SuspendedNot Applicable
Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia
Stopped: Funding not available
Hong Kong86 participantsStarted 2030-01-01
Plain-language summary
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.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (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.
Exclusion Criteria:
* (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) p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index
Timeframe: Baseline, immediately after the intervention, 7 weeks after the intervention
2
Changes over the measurement points in the brain activity during wakefulness
Timeframe: Baseline, immediately after the intervention, 7 weeks after the intervention
3
Changes over the measurement points in the heart rate variability
Timeframe: Baseline, immediately after the intervention, 7 weeks after the intervention
Trial details
NCT IDNCT06910423
SponsorCollege of Professional and Continuing Education Limited