Ba Duan Jin for CI With Hyperarousal/Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ba Duan Jin Exercise plus Sleep Hygiene Education
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Ba Duan Jin Exercise plus Sleep Hygiene EducationExperimental treatment 1 intervention
Group B: Sleep Hygiene Education OnlyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 6 weeksSecondary outcomes
1
The change of PSQI total scores from baseline to 3 months, 6 months, and 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.
Time frame
Baseline, 3 months, 6 months, 12 months2
The change of Insomnia severity index (ISI) total scores from baseline to 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.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months3
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
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.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months4
The change of sleep efficiency from baseline to 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).
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov