Depressive SymptomsNCT05482646
Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs
A study testing Tai Chi and Conventional exercise in people with Depressive Symptoms and Chronic Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depressive Symptoms, Chronic Insomnia
- What is being tested?
- Tai Chi and Conventional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Aug 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tai Chi Versus Conventional Exercise to Alleviate Depressive Symptoms in Older Insomniacs: A Three-arm Randomized Controlled Trial
This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.
Read the 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.
- Conditions
- Depressive Symptoms, Chronic Insomnia
- Being tested
- Tai Chi, Conventional exercise, Health Education Control
- Keywords
- Exercise, Tai Chi, Elderly, Depression, Insomnia
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
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 exerciseBehavioural
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 ControlBehavioural
Participants in the control group will participate in a health education program delivered by research personnel.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | This group will perform 3 months of Tai Chi training Receives: Behavioral: Tai Chi |
| Conventional exercise | Active comparator | This group will perform 3 months of conventional exercise training Receives: Behavioral: Conventional exercise |
| Health Education Control | Other | This group will participate in a 3-month health education program Receives: Behavioral: Health Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 months (6 months post-intervention follow-up)
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Medication usage
The use of medications will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start2 Aug 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
- Investigators
- Parco M Siu, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482646
- Sponsor's protocol ID
- TaiChiTrialHKU2020
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Versus Conventional Exercise to Alleviate Depressive Symptoms in Older Insomniacs: A Three-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05482646
- Acronym / sponsor ID
- TaiChiTrialHKU2020
- Conditions
- Depressive Symptoms, Chronic Insomnia
- Keywords
- Exercise, Tai Chi, Elderly, Depression, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiThis group will perform 3 months of Tai Chi training |
| Conventional exercise | Active comparator | Behavioral: Conventional exerciseThis group will perform 3 months of conventional exercise training |
| Health Education Control | Other | Behavioral: Health Education ControlThis group will participate in a 3-month health education program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiThe Tai Chi intervention will be prescribed as a 3-month program with two 1.5-h sessions weekly instructed by qualified Tai Chi instructors. | Behavioural | Tai Chi |
| Conventional exerciseThe 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. | Behavioural | Conventional exercise |
| Health Education ControlParticipants in the control group will participate in a health education program delivered by research personnel. | Behavioural | Health Education Control |
Primary outcome
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.
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.
20 secondary outcomes
Insomnia severity index
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Pittsburgh Sleep Quality Index
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Patient Health Questionnaire
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
General Anxiety Disorder Scale
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Hospital Anxiety and Depression Scale - Anxiety
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Medication usage
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
The 12-item Short Form Survey
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Short Physical Performance Battery
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Sleep efficiency through actigraph
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Sleep efficiency through sleep diary
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
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 through sleep diary
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Number of awakenings through actigraph
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Number of awakenings through sleep diary
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Sleep onset latency through actigraph
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Sleep onset latency through sleep diary
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Average awake time through actigraph
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Average awake time through sleep diary
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Total sleep time through actigraph
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Total sleep time through sleep diary
Time frame: 3 months (post-intervention) and 9 months (6 months post-intervention follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Related trials for Depressive Symptoms
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parco M Siu, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Conventional exercise in people with Depressive Symptoms and Chronic Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale - Depression (time frame: 3 months (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.