Effects of Tai Chi on Chronic Insomnia Disorder Combined With Hyperarousal/Anxiety
ConditionChronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
This study focuses on individuals with chronic insomnia combined with excessive arousal/anxiety, with the main objective of investigating the effectiveness of Tai Chi in treating CI with excessive arousal/anxiety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
meet DSM-5 diagnostic criteria for insomnia disorder;
Pittsburgh Sleep Quality Index (PSQI) total score >5;
age ≥18 years old with junior high school education or above;
voluntarily participate in this study by signing an informed consent form; and 5) HAMA ≥14 was required for those who had chronic insomnia disorder with anxiety symptoms.
Disqualifiers
people with comorbid serious physical or severe mental illnesses, suicide risk;
clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers;
pregnant and breastfeeding women; and
people who are currently undergoing any psychological treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Tai Chi + Sleep Hygiene Education
Other interventionConduct simplified training on the 24 style Tai Chi; Sleep hygiene education includes adjusting sleep time, maintaining regular lifestyle habits, optimizing bedroom environment, reducing nighttime stimulation, avoiding thinking when going to bed, adjusting alarm clock positions, and reducing daytime napping.
Sleep Hygiene Education
Other interventionParticipants will receive Sleep Hygiene Education, 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
80 Participants
are divided into 2 treatment groupsGroup A: Tai Chi + Sleep Hygiene EducationExperimental treatment 1 intervention
Group B: Sleep Hygiene EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment between the two groups.
Time frame
Baseline to week 6Secondary outcomes
1
Differences in the values of change from baseline in Hamilton Anxiety Scale (HAMA) scores at the end of treatment, and at 3 months, 6 months, and 12 months of follow-up between the two groups.
The scale consists of 14 items, and each item is rated on a 5-point scale from 0-4, with a total score of ≥29 for probable severe anxiety, a total score of ≥21 for definite significant anxiety, a total score of ≥14 for definite anxiety, a total score of ≥7 for probable anxiety, and \<7 for no symptoms of anxiety.
Time frame
Baseline to week 6, month 3, month 6, and month 122
Differences in change from baseline in Beck Anxiety Inventory (BAI) scores at the end of treatment, and at 3 months, 6 months and 12 months of follow-up between the two groups.
The scale contains 21 items and uses a 4-point scale method, with a total score of 15-25 as mild anxiety, 26-35 as moderate anxiety, and 36 or more as severe anxiety.
Time frame
Baseline to week 6, month 3, month 6, and month 123
Differences in the change from baseline in the insomnia severity index (ISI) scores at the end of treatment and at 3, 6 and 12 months of follow-up between the two groups.
The scale is divided into 7 sections with a total score of 0-28, with higher scores indicating more severe insomnia. The degree of insomnia is classified according to the scores: 0-7 indicates no insomnia, 8-14 is mild insomnia, 15-21 is moderate insomnia, and 22-28 is severe insomnia.
Time frame
Baseline to week 6, month 3, month 6, and month 12Sponsors and contacts
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Source ClinicalTrials.gov