Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs

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

Detailed Description
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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.

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

Conditions
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Depressive Symptoms, Chronic Insomnia

Intervention / Treatment
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* Behavioral: Tai Chi
* Behavioral: Conventional exercise
* Behavioral: Health Education Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>This group will perform 3 months of Tai Chi training | Behavioral: Tai Chi<br>* 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.<br>|
| Active Comparator: Conventional exercise<br>This group will perform 3 months of conventional exercise training | Behavioral: Conventional exercise<br>* 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.<br>|
| Other: Health Education Control<br>This group will participate in a 3-month health education program | Behavioral: Health Education Control<br>* Participants in the control group will participate in a health education program delivered by research personnel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale - Depression | 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. | 3 months (post-intervention) | 
| Hospital Anxiety and Depression Scale - Depression | 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. | 9 months (6 months post-intervention follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity index | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Pittsburgh Sleep Quality Index | 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 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Patient Health Questionnaire | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| General Anxiety Disorder Scale | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Hospital Anxiety and Depression Scale - Anxiety | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Medication usage | The use of medications will be recorded. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| The 12-item Short Form Survey | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Short Physical Performance Battery | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Sleep efficiency through actigraph | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Sleep efficiency through sleep diary | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Wake time after sleep onset through actigraph | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Wake time after sleep onset through sleep diary | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Number of awakenings through actigraph | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Number of awakenings through sleep diary | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Sleep onset latency through actigraph | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Sleep onset latency through sleep diary | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Average awake time through actigraph | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Average awake time through sleep diary | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Total sleep time through actigraph | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 
| Total sleep time through sleep diary | 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. | 3 months (post-intervention) and 9 months (6 months post-intervention follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Tai Chi, Elderly, Depression, Insomnia