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

NCT ID: NCT06910423

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia Randomised Controlled Trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Psychosocial intervention

Intervention Type BEHAVIORAL

Culturally relevant psychosocial intervention for people with insomnia

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.

Group Type EXPERIMENTAL

Psychosocial intervention

Intervention Type BEHAVIORAL

Culturally relevant psychosocial intervention for people with insomnia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychosocial intervention

Culturally relevant psychosocial intervention for people with insomnia

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

College of Professional and Continuing Education Limited

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victoria Ka-Ying Dr. HUI, PhD

Role: PRINCIPAL_INVESTIGATOR

College of Professional and Continuing Education Limited

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Social Sciences, Humanities and Design

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr. Victoria Ka-Ying HUI, PhD

Role: CONTACT

+852 3746 0299

Dr. Stephanie Wing LEE, PhD

Role: CONTACT

+852 3746 0063

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Victoria Ka-Ying HUI, PhD

Role: primary

+852 3749 0299

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 34634445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38248306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35936346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23983785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37310329 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC_ETH_H_274

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Somatic Tracking for Tinnitus
NCT06895824 RECRUITING NA
Mindfulness-Based Approaches to Insomnia
NCT00768781 COMPLETED PHASE2