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

NCT06967974 | Recruiting

• 1 other identifier: Tai Chi for CI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia; Tai Chi; hyperawareness; anxiety

Outcome Measures

Primary Outcomes (1)

• Difference in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment between the two groups.

  Baseline to week 6

Secondary Outcomes (3)

• 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.

  Baseline to week 6, month 3, month 6, and month 12

• 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.

  Baseline to week 6, month 3, month 6, and month 12

• 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.

  Baseline to week 6, month 3, month 6, and month 12

Study Arms (2)

Tai Chi + Sleep Hygiene Education

EXPERIMENTAL

Other: Tai Chi + Sleep Hygiene Education

Sleep Hygiene Education

ACTIVE COMPARATOR

Other: Sleep Hygiene Education

Interventions

Tai Chi + Sleep Hygiene Education 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.

Tai Chi + Sleep Hygiene Education

Sleep Hygiene Education 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.

Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@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)