Study of Ba Duan Jin Exercise to Improve Chronic Insomnia with Anxiety and Hyperarousal
Led by Xuanwu Hospital, Beijing · Updated on 2025-05-23
84
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate how well Ba Duan Jin exercise works in treating chronic insomnia CI in people who also have hyperarousal and anxiety symptoms. Chronic insomnia causes ongoing trouble falling or staying asleep, leading to problems during the day. Many patients with CI experience increased physical and mental alertness, often with anxiety, which worsens sleep quality and daily life. This trial is designed as a randomized controlled study involving 84 participants to compare different approaches for managing these symptoms.
Participants will be randomly assigned to one of two groups one group will practice Ba Duan Jin, a traditional Chinese Qigong exercise consisting of eight gentle movements designed to promote relaxation, combined with Sleep Hygiene Education SHE. They will practice Ba Duan Jin daily for 50 minutes over 6 weeks. The other group will receive only Sleep Hygiene Education, which includes advice on healthy sleep habits, environment, and reducing stimulants. This design allows researchers to assess the added effects of Ba Duan Jin on sleep and anxiety symptoms.
During the study, participants will have their sleep quality measured using the Pittsburgh Sleep Quality Index PSQI at the start and after 6 weeks. Additional assessments will track changes in insomnia severity, beliefs about sleep, sleep efficiency, mood, anxiety, depression, and quality of life at multiple points up to 12 months. This thorough monitoring helps evaluate both short- and longer-term effects. The study includes safety checks and follow-up visits to ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
Ba Duan Jin for CI With Hyperarousal/Anxiety
Research Team
H
Hongxing Wang, MD & PhD
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Diagnosed with Insomnia Disorder according to DSM-5 criteria
Pittsburgh Sleep Quality Index (PSQI) total score greater than 5
Age 8 years or older
Educational level of at least junior high school
Voluntarily agree to participate and sign informed consent
Presence of anxiety symptoms with Hamilton Anxiety Rating Scale (HAMA-14) score of 14 or higher
You will not qualify if you...
Presence of severe physical illnesses or major psychiatric disorders, or risk of suicide
Diagnosis or suspicion of sleep breathing disorder, restless legs syndrome, circadian rhythm sleep disorder, or night-shift work
Pregnancy or breastfeeding
Currently undergoing any form of psychological therapy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 6 weeks
Participants either practice Ba Duan Jin exercise daily combined with Sleep Hygiene Education or receive Sleep Hygiene Education alone to improve sleep quality and reduce anxiety symptoms.
Daily practice for 50 minutes (for Ba Duan Jin group)
Follow-up
Duration - Up to 12 months after treatment
Participants are assessed for sleep quality and anxiety symptoms up to 12 months after treatment completion.
Visits at 3 months, 6 months, and 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.