Clinical trial NCT06967974: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: Chronic Insomnia
Tai Chi
hyperawareness
anxiety
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment between the two groups.
timeFrame: Baseline to week 6
Secondary outcomes:
measure: 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.
timeFrame: Baseline to week 6, month 3, month 6, and month 12
measure: 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.
timeFrame: Baseline to week 6, month 3, month 6, and month 12
measure: 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.
timeFrame: Baseline to week 6, month 3, month 6, and month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: