Clinical trial NCT06969079: Ba Duan Jin for CI With Hyperarousal/Anxiety
Official title: Effectiveness of Ba Duan Jin Exercise on Chronic Insomnia (CI) With Hyperarousal/Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mind-Body Therapies
Insomnia Chronic
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: 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
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Scores
timeFrame: Baseline, Week 6, 3 months, 6 months, and 12 months
measure: The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: 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.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References:
citation: 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.