Ba Duan Jin for CI With Hyperarousal/Anxiety

NCT ID: NCT06969079

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of Ba Duan Jin exercise in treating chronic insomnia (CI) with comorbid hyperarousal and anxiety symptoms.

Detailed Description

Chronic Insomnia (CI) is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep, leading to significant daytime dysfunction. Many CI patients experience hyperarousal, both physiological and psychological, commonly manifested as anxiety, which further exacerbates sleep disturbances and reduces quality of life.

While pharmacotherapy and cognitive behavioral therapy (CBT) are effective for some patients, they are limited by side effects, costs, and accessibility. Traditional mind-body practices such as Ba Duan Jin, a classic Chinese Qigong exercise, have been explored as alternative therapies to improve sleep quality and alleviate anxiety symptoms.

Ba Duan Jin consists of a sequence of gentle and flowing movements designed to promote physical and mental relaxation. Preliminary studies suggest that mind-body exercises like Ba Duan Jin can positively influence sleep patterns, psychological well-being, and overall health.

This randomized controlled trial will recruit 84 participants diagnosed with CI and comorbid hyperarousal/anxiety symptoms. Participants will be randomly assigned to either a Ba Duan Jin plus Sleep Hygiene Education (SHE) group or an SHE-only group.

The intervention will last for 6 weeks, with participants in the Ba Duan Jin group practicing once daily for 50 minutes.

Conditions

Mind-Body Therapies; Insomnia Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ba Duan Jin Exercise plus Sleep Hygiene Education

Group Type: EXPERIMENTAL

Ba Duan Jin Exercise plus Sleep Hygiene Education

Intervention Type: BEHAVIORAL

Participants will receive Ba Duan Jin exercise combined with Sleep Hygiene Education. The Ba Duan Jin intervention consists of eight traditional Chinese Qigong movements performed daily for 6 weeks, with each session lasting 50 minutes, accompanied by structured sleep hygiene counseling.

Sleep Hygiene Education Only

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type: BEHAVIORAL

Participants will receive Sleep Hygiene Education (SHE) alone, consisting of guidance on establishing healthy sleep habits, optimizing sleep environment, adjusting sleep schedules, reducing stimulants (e.g., caffeine, alcohol), and minimizing sleep-disruptive behaviors.

Interventions

Ba Duan Jin Exercise plus Sleep Hygiene Education

Participants will receive Ba Duan Jin exercise combined with Sleep Hygiene Education. The Ba Duan Jin intervention consists of eight traditional Chinese Qigong movements performed daily for 6 weeks, with each session lasting 50 minutes, accompanied by structured sleep hygiene counseling.

Intervention Type: BEHAVIORAL

Sleep Hygiene Education

Participants will receive Sleep Hygiene Education (SHE) alone, consisting of guidance on establishing healthy sleep habits, optimizing sleep environment, adjusting sleep schedules, reducing stimulants (e.g., caffeine, alcohol), and minimizing sleep-disruptive behaviors.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with Insomnia Disorder according to DSM-5 criteria.

2. Pittsburgh Sleep Quality Index (PSQI) total score > 5.

3. Age ≥ 8 years.

4. Educational level of at least junior high school.

5. Voluntarily agree to participate and sign informed consent.

6. Presence of anxiety symptoms, defined as a Hamilton Anxiety Rating Scale (HAMA-14) score ≥ 14.

Exclusion Criteria

1. Presence of severe physical illnesses or major psychiatric disorders, or assessed to be at risk of suicide.

2. Diagnosis or suspicion of sleep breathing disorder, restless legs syndrome, circadian rhythm sleep disorder, or engaged in night-shift work.

3. Pregnancy or breastfeeding.

4. Currently undergoing any form of psychological therapy.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

References

Fan B, Song W, Zhang J, Er Y, Xie B, Zhang H, Liao Y, Wang C, Hu X, Mcintyre R, Lee Y. The efficacy of mind-body (Baduanjin) exercise on self-reported sleep quality and quality of life in elderly subjects with sleep disturbances: a randomized controlled trial. Sleep Breath. 2020 Jun;24(2):695-701. doi: 10.1007/s11325-019-01999-w. Epub 2020 Jan 2.

Reference Type: BACKGROUND

PMID: 31898191 (View on PubMed)

Other Identifiers

CI+HA-BDJ

Identifier Type: -

Identifier Source: org_study_id