Clinical trial NCT06910423: Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Randomised Controlled Trial
Keywords: Mahayana Buddhist Awareness Training Program
Electroencephalography
Qigong
Hong Kong
Lead sponsor: College of Professional and Continuing Education Limited
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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) pregnancy

Primary outcomes:
measure: Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the brain activity during wakefulness
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the heart rate variability
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
Secondary outcomes:
measure: Changes over the measurement points in the 7-item Insomnia Severity Index
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the 16-item Pre-Sleep Arousal Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the 5-item item Santa Clara Brief Compassion Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the PROMIS® 2-item Global Physical Health-2 Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the PROMIS® 2-item Global Mental Health-2 Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the 6-item Qi Stagnation Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the 6-item Qi Deficiency Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the 2-item Generalized Anxiety Disorder-2 Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
measure: Changes over the measurement points in the 2-item Patient Health Questionnaire-2 Scale
timeFrame: Baseline, immediately after the intervention, 7 weeks after the intervention
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Treatment Acceptance
timeFrame: Immediately after the intervention
Locations:
city: Hong Kong
country: Hong Kong
facility: Division of Social Sciences, Humanities and Design
Study officials:
affiliation: College of Professional and Continuing Education Limited
name: Victoria Ka-Ying Dr. HUI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu BWY, Gao J, Leung HK, Sik HH. A randomized controlled trial of Awareness Training Program (ATP), a group based Mahayana Buddhist intervention. Mindfulness. 2019;10:1280 1293. https://doi.org/10.1007/s12671-018-1082-1
citation: Ng SM, Yin MXC, Chan JSM, Chan CHY, Fong TCT, Li A, So KF, Yuen LP, Chen JP, Chung KF, Chan CLW. Impact of mind-body intervention on proinflammatory cytokines interleukin 6 and 1beta: A three-arm randomized controlled trial for persons with sleep disturbance and depression. Brain Behav Immun. 2022 Jan;99:166-176. doi: 10.1016/j.bbi.2021.09.022. Epub 2021 Oct 8.
citation: Lee KCG, Gao J, Leung HK, Wu BWY, Roberts A, Thach TQ, Sik HH. Modulating Consciousness through Awareness Training Program and Its Impacts on Psychological Stress and Age-Related Gamma Waves. Brain Sci. 2024 Jan 17;14(1):91. doi: 10.3390/brainsci14010091.
citation: Gao J, Leung HK, Fan J, Wu BWY, Sik HH. The neurophysiology of the intervention strategies of Awareness Training Program on emotion regulation. Front Psychol. 2022 Jul 22;13:891656. doi: 10.3389/fpsyg.2022.891656. eCollection 2022.
citation: Chan JS, Ho RT, Wang CW, Yuen LP, Sham JS, Chan CL. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:485341. doi: 10.1155/2013/485341. Epub 2013 Jul 31.
citation: Chan CS, Wong CYF, Yu BYM, Hui VKY, Ho FYY, Cuijpers P. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial. Psychol Med. 2023 Apr;53(5):1799-1813. doi: 10.1017/S0033291721003421. Epub 2021 Aug 23.