Ba Duan Jin for CI With Hyperarousal/Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ba Duan Jin Exercise plus Sleep Hygiene Education, Sleep Hygiene Education.
- Who it may be relevant to
- Registry conditions: Mind-Body Therapies, Insomnia Chronic. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Ba Duan Jin Exercise on Chronic Insomnia (CI) With Hyperarousal/Anxiety
Overview
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.
Interventions
- Behavioral 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. - 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.
Primary outcome measures
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks [Time frame: Baseline, 6 weeks]
Secondary outcome measures (12)
- The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months [Time frame: Baseline, 3 months, 6 months, 12 months]
- The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Scores [Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months]
- The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
Eligibility criteria
Inclusion criteria
- Diagnosed with Insomnia Disorder according to DSM-5 criteria.
- Pittsburgh Sleep Quality Index (PSQI) total score > 5.
- Age ≥ 8 years.
- Educational level of at least junior high school.
- Voluntarily agree to participate and sign informed consent.
- Presence of anxiety symptoms, defined as a Hamilton Anxiety Rating Scale (HAMA-14) score ≥ 14.
Exclusion criteria
- Presence of severe physical illnesses or major psychiatric disorders, or assessed to be at risk of suicide.
- Diagnosis or suspicion of sleep breathing disorder, restless legs syndrome, circadian rhythm sleep disorder, or engaged in night-shift work.
- Pregnancy or breastfeeding.
- Currently undergoing any form of psychological therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Publications
- 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. PMID 31898191
Identifiers
NCT: NCT06969079 · CI+HA-BDJ