Ba Duan Jin for CI With Hyperarousal/Anxiety

May 19, 2025 updated by: Xuanwu Hospital, Beijing

Effectiveness of Ba Duan Jin Exercise on Chronic Insomnia (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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ba Duan Jin Exercise plus Sleep Hygiene Education
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.
Active Comparator: Sleep Hygiene Education Only
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 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.
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 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.
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 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.
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 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.
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 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.
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
Baseline, Week 6, 3 months, 6 months, and 12 months
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.
Baseline, 3 months, 6 months, 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
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Baseline, 6 weeks, 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 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).
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 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
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
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.
Baseline, 6 weeks, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CI+HA-BDJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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