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

Official title

Evaluation of Tai Chi for Chronic Insomnia Disorder Combined With Hyperarousal/Anxiety

Overview

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.

Interventions

• Other 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.
• 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.

Primary outcome measures

• 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 6]

Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: Baseline to week 6, month 3, month 6, and month 12]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06967974 · Tai Chi for CI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗