Back to resultsTai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs
Primary Purpose
Depressive Symptoms, Chronic Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tai Chi
Conventional exercise
Health Education Control
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms focused on measuring Exercise, Tai Chi, Elderly, Depression, Insomnia
Eligibility Criteria
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.
Sites / Locations
- LKS Faculty of Medicine, HKURecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Tai Chi
Conventional exercise
Health Education Control
Arm Description
This group will perform 3 months of Tai Chi training
This group will perform 3 months of conventional exercise training
This group will participate in a 3-month health education program
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Medication usage
The use of medications will be recorded.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05482646
First Posted
July 27, 2022
Last Updated
August 2, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05482646
Brief Title
Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs
Official Title
Tai Chi Versus Conventional Exercise to Alleviate Depressive Symptoms in Older Insomniacs: A Three-arm Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Chronic Insomnia
Keywords
Exercise, Tai Chi, Elderly, Depression, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
This group will perform 3 months of Tai Chi training
Arm Title
Conventional exercise
Arm Type
Active Comparator
Arm Description
This group will perform 3 months of conventional exercise training
Arm Title
Health Education Control
Arm Type
Other
Arm Description
This group will participate in a 3-month health education program
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Control
Intervention Description
Participants in the control group will participate in a health education program delivered by research personnel.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale - Depression
Description
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.
Time Frame
3 months (post-intervention)
Title
Hospital Anxiety and Depression Scale - Depression
Description
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.
Time Frame
9 months (6 months post-intervention follow-up)
Secondary Outcome Measure Information:
Title
Insomnia severity index
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Patient Health Questionnaire
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
General Anxiety Disorder Scale
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Hospital Anxiety and Depression Scale - Anxiety
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Medication usage
Description
The use of medications will be recorded.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
The 12-item Short Form Survey
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Short Physical Performance Battery
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Sleep efficiency through actigraph
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Sleep efficiency through sleep diary
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Wake time after sleep onset through actigraph
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Wake time after sleep onset through sleep diary
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Number of awakenings through actigraph
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Number of awakenings through sleep diary
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Sleep onset latency through actigraph
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Sleep onset latency through sleep diary
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Average awake time through actigraph
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Average awake time through sleep diary
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Total sleep time through actigraph
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Title
Total sleep time through sleep diary
Description
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.
Time Frame
3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parco M Siu, PhD
Phone
283
Ext
15262
Email
pmsiu@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Angus Yu, PhD
Phone
67533806
Email
phayu@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco M Siu, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKS Faculty of Medicine, HKU
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angus Yu, PhD
Phone
67533806
Email
phayu@hku.hk
First Name & Middle Initial & Last Name & Degree
Parco M Siu, PhD
12. IPD Sharing Statement
Learn more about this trial
Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs
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