Buddhist Awareness Training Program and Qigong Psychosocial Interventions for People With Insomnia

NCT06910423 | Suspended

• 1 other identifier: RC_ETH_H_274
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Randomised Controlled Trial

Keywords

Mahayana Buddhist Awareness Training Program; Electroencephalography; Qigong; Hong Kong

Outcome Measures

Primary Outcomes (3)

• Changes over the measurement points in the 19-item Pittsburgh Sleep Quality Index

  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.

  Baseline, immediately after the intervention, 7 weeks after the intervention

• Changes over the measurement points in the brain activity during wakefulness

  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).

  Baseline, immediately after the intervention, 7 weeks after the intervention

• Changes over the measurement points in the heart rate variability

  This will be measured by the same wearable UMindSleep device.

  Baseline, immediately after the intervention, 7 weeks after the intervention

Secondary Outcomes (9)

• 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

Other Outcomes (2)

• Demographics

  Baseline

• Treatment Acceptance

  Immediately after the intervention

Study Arms (2)

Mahayana Buddhist Awareness Training Program (ATP)

EXPERIMENTAL

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.

Behavioral: Psychosocial intervention

Qigong Intervention

EXPERIMENTAL

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.

Behavioral: Psychosocial intervention

Interventions

Psychosocial intervention BEHAVIORAL

Culturally relevant psychosocial intervention for people with insomnia

Mahayana Buddhist Awareness Training Program (ATP); Qigong Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• College of Professional and Continuing Education Limited: lead

Study Sites (1)

Division of Social Sciences, Humanities and Design

Hong Kong, Hong Kong

Location

Related Publications (6)

• 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

  BACKGROUND

• 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.

  PMID: 34634445 BACKGROUND

• 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.

  PMID: 38248306 BACKGROUND

• 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.

  PMID: 35936346 BACKGROUND

• 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.

  PMID: 23983785 BACKGROUND

• 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.

  PMID: 37310329 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Victoria Ka-Ying Dr. HUI, PhD

  College of Professional and Continuing Education Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 4, 2025
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)