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NCT Number: NCT06969079

Ba Duan Jin for CI With Hyperarousal/Anxiety

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.

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Key information

Conditions

Mind-Body Therapies Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location status: Recruiting

Location contact

Hongxing Wang, MD & PhD

CONTACT

[email protected]

+86 13911127385

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ba Duan Jin Exercise plus Sleep Hygiene Education

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

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.

Primary outcomes

  1. The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks

    Time frame: Baseline, 6 weeks

    The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

Secondary outcomes

  1. 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 PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

  2. 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 ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.

  3. 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 DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.

  4. 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

    Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).

  5. Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Scores

    Time frame: Baseline, Week 6, 3 months, 6 months, and 12 months

  6. 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 SF-36 quantifying the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).

  7. 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 PHQ-4 comprises a 2-item depression scale and a 2-item anxiety scale. Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.

  8. 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 BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.

  9. 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 BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.

  10. 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 PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress

  11. 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 PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.

  12. 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

    The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxing Wang, MD & PhD

CONTACT

[email protected]

+86 13911127385

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Effectiveness of Ba Duan Jin Exercise on Chronic Insomnia (CI) With Hyperarousal/Anxiety

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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