Effects of Tai Chi on Chronic Insomnia Disorder Combined With Hyperarousal/Anxiety

NCT ID: NCT06967974

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

Brief Summary

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.

Detailed Description

Patients with chronic insomnia often experience both daytime fatigue and difficulty falling asleep at night, as well as shallow sleep and easy awakening, which is a manifestation of 24-hour excessive wakefulness. Additionally, insomnia is often associated with anxiety and tension. Therefore, for patients with chronic insomnia accompanied by anxiety, relieving anxiety is often an important means of treating insomnia. In recent years, an increasing number of studies have shown that Tai Chi has potential therapeutic value in treating mental disorders such as insomnia and anxiety. Tai Chi is a coordinated and unified physical and mental exercise that regulates the body's functional state through rhythmic and regular physical activities, and is combined with psychological "relaxation" activities. Therefore, the investigators propose the hypothesis that Tai Chi training may improve chronic insomnia with excessive arousal/anxiety through intermediate pathways such as neuroendocrine, immune function, neurochemistry, etc. This study aims to explore the effects of Tai Chi on chronic insomnia combined with excessive arousal/anxiety, broaden new ideas for non pharmacological treatment of sleep problems, and provide data reference for the development of more precise sleep aid exercise plans in the future.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tai Chi + Sleep Hygiene Education

Group Type: EXPERIMENTAL

Tai Chi + Sleep Hygiene Education

Intervention Type: OTHER

Conduct 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

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type: OTHER

Participants 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.

Interventions

Tai Chi + Sleep Hygiene Education

Conduct 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.

Intervention Type: OTHER

Sleep Hygiene Education

Participants 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. meet DSM-5 diagnostic criteria for insomnia disorder;

2. Pittsburgh Sleep Quality Index (PSQI) total score >5;

3. age ≥18 years old with junior high school education or above;

4. 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.

Exclusion Criteria

1. people with comorbid serious physical or severe mental illnesses, suicide risk;

2. clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers;

3. pregnant and breastfeeding women; and

4. people who are currently undergoing any psychological treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Other Identifiers

Tai Chi for CI

Identifier Type: -

Identifier Source: org_study_id