NCT06969079

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 5, 2025

Last Update Submit

May 19, 2025

Conditions

Mind-Body TherapiesInsomnia Chronic

Outcome Measures

Primary Outcomes (1)

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 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 Outcomes (12)

  • The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months

    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

    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

    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

    Baseline, 6 weeks, 3 months, 6 months, and 12 months

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

    Baseline, Week 6, 3 months, 6 months, and 12 months

  • +7 more secondary outcomes

Study Arms (2)

Ba Duan Jin Exercise plus Sleep Hygiene Education

EXPERIMENTAL
Behavioral: Ba Duan Jin Exercise plus Sleep Hygiene Education

Sleep Hygiene Education Only

ACTIVE COMPARATOR
Behavioral: Sleep Hygiene Education

Interventions

Ba Duan Jin Exercise plus Sleep Hygiene EducationBEHAVIORAL

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.

Ba Duan Jin Exercise plus Sleep Hygiene Education
Sleep Hygiene EducationBEHAVIORAL

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.

Sleep Hygiene Education Only

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Related Publications (1)

  • 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: 31898191BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385wanghongxing@xwh.ccmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

November 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)