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Completed

NCT Number: NCT05482646

Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs

This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Chronic Insomnia Depression Dyssomnias Mental Disorders Motor Activity Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKS Faculty of Medicine, HKU

Hong Kong

About this study

Chinese community-dwelling older adults with mild-to-moderate depressive symptoms and chronic insomnia will be recruited.

Eligible participants will be randomized to health education control, Tai Chi or conventional exercise interventions on a 1:1:1 basis after baseline assessment.

All interventions will last for 3 months. Outcomes will be assessed at baseline, at 3 months and at 6 months after the completion of the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 years or older
  • Can communicate using Cantonese or Mandarin
  • with mild-to-moderate depressive symptoms (HADS-depression score ≥8/21 and PHQ- 9 score ≤14/27)
  • Fulfil the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for chronic insomnia including difficulties in initiating or maintaining sleep, early morning awakening with complaint of significant distress or impairment of daytime functioning, sleep difficulty occurring at least three nights per week and present for at least 3 months.

Exclusion criteria

  • Somatic condition that prevents participation in tai chi or exercise
  • Regular moderate-to-vigorous intensity exercise or mind-body training such as tai chi, yoga, qigong or meditation in the past 3 months
  • Any form (or combination) of exercises amounting to 180 minutes per week in the past 3 months
  • Dementia
  • Diagnosis with schizophrenia or other psychotic disorders, bipolar disorders or alcohol/substance use/abuse
  • Current usage or planning to use potentially confounding treatments, including herbal supplementations (e.g., St. John's Wort), acupuncture treatment, cognitive behavioral therapy or other psychotherapy, mind-body intervention (e.g., mindfulness training and muscle relaxation training) or muscle relaxants such as carisoprodol, cyclobenzaprine, diazepam
  • Current suicidal or self-injurious potential that requires immediate clinical follow-up.

Treatment and study plan

Tai Chi

Behavioral

The Tai Chi intervention will be prescribed as a 3-month program with two 1.5-h sessions weekly instructed by qualified Tai Chi instructors.

Conventional Exercise

Behavioral

The conventional exercise intervention will be prescribed as a 3-month program with two 1.5-h sessions of generic fitness training weekly instructed by qualified instructors.

Health Education Control

Behavioral

Participants in the control group will participate in a health education program delivered by research personnel.

Primary outcomes

  1. Hospital Anxiety and Depression Scale - Depression

    Time frame: 3 months (post-intervention)

    The depression score of the Hospital Anxiety and Depression Scale (HADS-D) will be used to evaluate the severity of depressive symptoms. This consists of a seven-item questionnaire with an overall score ranging from 0 to 21. Higher scores are indicative of more severe depressive symptoms.

  2. Hospital Anxiety and Depression Scale - Depression

    Time frame: 9 months (6 months post-intervention follow-up)

    The depression score of the Hospital Anxiety and Depression Scale (HADS-D) will be used to evaluate the severity of depressive symptoms. This consists of a seven-item questionnaire with an overall score ranging from 0 to 21. Higher scores are indicative of more severe depressive symptoms.

Secondary outcomes

  1. Insomnia severity index

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The Insomnia Severity Index (ISI) will be used to assess perceived insomnia severity. It consists of a seven-item questionnaire with each item being rated from 0 to 4 on a Likert scale (total score range 0-28). Higher scores are representative of a more severe perception of insomnia.

  2. Pittsburgh Sleep Quality Index

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The Pittsburgh Sleep Quality Index (PSQI) will be used to assess subjective sleep quality. It consists of a 19-item questionnaire designed to measure sleep quality and disturbance. The 19 items are grouped into 7 components, and each component yields a score ranging from 0 to 3, with 3 indicating the greatest sleep dysfunction. The total score of the PSQI ranges from 0 to 21, with higher scores indicating worse sleep quality.

  3. Patient Health Questionnaire

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The Patient Health Questionnaire (PHQ-9) will be used to assess the severity of depression. The questionnaire is composed of 9 items, with each item being rated from 0 to 3. The PHQ-9 has a total score ranging from 0 to 27, with higher scores suggesting higher depressive symptom severity.

  4. General Anxiety Disorder Scale

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The General Anxiety Disorder Scale (GAD-7) will be used to assess the severity of anxiety. The GAD-7 is composed of 7 items, each being rated from 0 to 3 and with a total score range of 0-21. Higher scores are representative of greater anxiety symptoms.

  5. Hospital Anxiety and Depression Scale - Anxiety

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The anxiety score of the Hospital Anxiety and Depression Scale (HADS-A) will be used to assess the severity of anxiety symptoms. The HADS-A consists of a seven-item questionnaire with an overall score ranging from 0 to 21. Higher scores are indicative of greater anxiety symptoms.

  6. Medication usage

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The use of medications will be recorded.

  7. The 12-item Short Form Survey

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The 12-item Short Form Survey (SF-12) will be used to measure health-related quality of life. It consists of 12 items that are aggregated to form 2 summary scores: mental component score (MCS) and physical component score (PCS). Both MCS and PCS have a scoring range of 0 to 100, with higher scores indicating better mental and physical functioning.

  8. Short Physical Performance Battery

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The Short Physical Performance Battery (SPPB) will be used to assess physical function and balancing performance. The SPPB involves repeated timed chair stands and a 4-meter walk to measure gait speed. Scores ranging from 1 to 4 are assigned based on test results, with higher scores indicating better physical function and balance.

  9. Sleep efficiency through actigraph

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Sleep efficiency will be objectively evaluated by means of an actigraph. Sleep efficiency is the ratio between the time spent asleep and the total time spent in bed (expressed as %). Higher rates are indicative of healthier sleep patterns.

  10. Sleep efficiency through sleep diary

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Sleep efficiency will be subjectively evaluated by means of a sleep diary. Sleep efficiency is the ratio between the time spent asleep and the total time spent in bed (expressed as %). Higher rates are indicative of healthier sleep patterns.

  11. Wake time after sleep onset through actigraph

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Wake time after sleep onset will be objectively measured by means of an actigraph. It represents the total number of minutes that a person is awake after having initially fallen asleep (expressed as minutes). Higher values are indicative of more severe sleep problems.

  12. Wake time after sleep onset through sleep diary

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Wake time after sleep onset will be subjectively measured by means of a sleep diary. It represents the total number of minutes that a person is awake after having initially fallen asleep (expressed as minutes). Higher values are indicative of more severe sleep problems.

  13. Number of awakenings through actigraph

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The number of awakenings will be objectively measured by means of an actigraph. It represents the total number of times that the participant woke up throughout the night (expressed as N). Higher values indicate worse sleep patterns.

  14. Number of awakenings through sleep diary

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    The number of awakenings will be subjectively measured by means of a sleep diary. It represents the total number of times that the participant woke up throughout the night (expressed as N). Higher values indicate worse sleep patterns.

  15. Sleep onset latency through actigraph

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Sleep onset latency will be objectively measured by means of an actigraph. It represents the time that it takes for a participant to fall asleep and is expressed in minutes. Higher values are indicative of worse sleep patterns.

  16. Sleep onset latency through sleep diary

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Sleep onset latency will be subjectively measured by means of a sleep diary. It represents the time that it takes for a participant to fall asleep and is expressed in minutes. Higher values are indicative of worse sleep patterns.

  17. Average awake time through actigraph

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Average awake time will be objectively measured by means of an actigraph. It is expressed as wake time after sleep onset divided by the number of awakenings, and is expressed in minutes. Higher values represent worse sleep patterns.

  18. Average awake time through sleep diary

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Average awake time will be subjectively measured by means of a sleep diary. It is expressed as wake time after sleep onset divided by the number of awakenings, and is expressed in minutes. Higher values represent worse sleep patterns.

  19. Total sleep time through actigraph

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Total sleep time will be objectively measured by means of an actigraph. It represents the total number of minutes spent asleep during the sleep period (expressed as minutes). Higher values are indicative of healthier sleep patterns.

  20. Total sleep time through sleep diary

    Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

    Total sleep time will be subjectively measured by means of a sleep diary. It represents the total number of minutes spent asleep during the sleep period (expressed as minutes). Higher values are indicative of healthier sleep patterns.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Tai Chi Versus Conventional Exercise to Alleviate Depressive Symptoms in Older Insomniacs: A Three-arm Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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