DepressionNCT04609631
Tai Chi for Comorbid Depression in T2DM Patients
A study testing Tai Chi and CBT in people with Depression and T2DM, run by Chengdu University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
Previous studies suggested that Tai Chi may be beneficial for T2DM patients. However, no studies have investigated the effectiveness of Tai Chi for comorbid depression in T2DM patients, as well as the optimal frequency of Tai Chi. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, T2DM
- What is being tested?
- Tai Chi and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2020to Dec 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with depression by experienced psychiatrist;
- Participants diagnosed with T2DM by experienced endocrinologist;
- Participants aged between 18~75 years;
- Participants with HbA1c ranges from 6.5% to 8.5%;
- Participants with Hamilton Depression Scale (HAMD) (24-item-version) ranges from 20~35 scores;
- Participants passed the Physical Activity Readiness Questionnaire (PAR-Q);
- Participants willing to complete 12-week intervention and 12-week follow-up.
- Participants willing to sign informed consent form.
Who cannot join
- Participants with uncontrolled hypertension (SBP >160mmHg or DBP >100mmHg after taking hypotensive drugs);
- Participants with severe diabetic complications;
- Regular exercisers (at least 20 minutes/time, 3 times/week) in the last 3 months;
- Participants with cognitive impairment (Montreal Cognitive Assessment [MoCA] scores <26);
- Participants with history of bipolar disorder or schizophrenia or other mental illness;
- Participants with contraindications to exercise;
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- Participants with acute, infectious diseases, cancer, or serious neurological disease, cardiovascular disease, pulmonary disease or other serious medical conditions limiting the ability;
- Participants taking psychoactive drugs;
- Participants participating in other clinical trials at the same time.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
Chengdu, Sichuan, 610075
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
Henan University of Chinese Medicine
Zhengzhou, Henan, 450046
About this study
Official title: Tai Chi for Comorbid Depression in T2DM Patients: A Randomized Controlled Trial Protocol
Previous studies suggested that Tai Chi may be beneficial for T2DM patients. However, no studies have investigated the effectiveness of Tai Chi for comorbid depression in T2DM patients, as well as the optimal frequency of Tai Chi. Thus, we intend to investigate the effectiveness of Tai Chi for comorbid depression in T2DM patients and test whether the effectiveness of Tai Chi depends on its frequency.
- Conditions
- Depression, T2DM
- Being tested
- Tai Chi, CBT
- Keywords
- Tai Chi, Depression, T2DM, Randomized Controlled Trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes).
CBTBehavioural
CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi (5 times/week) | Experimental | 5 sessions of Tai Chi per week for 12 weeks Receives: Behavioral: Tai Chi |
| Tai Chi (3 times/week) | Experimental | 3 sessions of Tai Chi per week for 12 weeks Receives: Behavioral: Tai Chi |
| Tai Chi (1 time/week) | Experimental | 1 session of Tai Chi per week for 12 weeks Receives: Behavioral: Tai Chi |
| cognitive behavior therapy (CBT) | Active comparator | 1 session of CBT per week for 12 weeks Receives: Behavioral: CBT |
| Waiting-list | No intervention | Participants will maintain their routine treatment and life style for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg depression rating scale
Measured: change from baseline to 12 weeks after intervention
Secondary outcomes (9)
Montgomery Asberg depression rating scale
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Hamilton Depression Scale (HAMD) (24-item-version)
Measured: change from baseline, after intervention (12 weeks), after follow-up (24 weeks)
Social Disability Screening Schedule
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
EuroQol-5D questionnaire
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Clinical Global Impression scale
Measured: after intervention (12 weeks), after follow-up (24 weeks)
Biochemical indicators
HbA1c
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Fasting plasma glucose
Biochemical indicators
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Postprandial plasma glucose
Biochemical indicators
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
insulin level
Biochemical indicators
Measured: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Jan 2020
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Electronic Science and Technology of China
- Responsible party
- Principal investigator, Di Qin, Chengdu University of Traditional Chinese Medicine
- Investigators
- Youping Liu, PhD, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609631
- Sponsor's protocol ID
- 2019YFC1710302
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Comorbid Depression in T2DM Patients: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04609631
- Acronym / sponsor ID
- 2019YFC1710302
- Conditions
- Depression, T2DM
- Keywords
- Tai Chi, Depression, T2DM, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- University of Electronic Science and Technology of China
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Oct 2020 (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.
Previous studies suggested that Tai Chi may be beneficial for T2DM patients. However, no studies have investigated the effectiveness of Tai Chi for comorbid depression in T2DM patients, as well as the optimal frequency of Tai Chi. Thus, we intend to investigate the effectiveness of Tai Chi for comorbid depression in T2DM patients and test whether the effectiveness of Tai Chi depends on its frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tai Chi (5 times/week) | Experimental | Behavioral: Tai Chi5 sessions of Tai Chi per week for 12 weeks |
| Tai Chi (3 times/week) | Experimental | Behavioral: Tai Chi3 sessions of Tai Chi per week for 12 weeks |
| Tai Chi (1 time/week) | Experimental | Behavioral: Tai Chi1 session of Tai Chi per week for 12 weeks |
| cognitive behavior therapy (CBT) | Active comparator | Behavioral: CBT1 session of CBT per week for 12 weeks |
| Waiting-list | No intervention | –Participants will maintain their routine treatment and life style for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants diagnosed with depression by experienced psychiatrist;
- Participants diagnosed with T2DM by experienced endocrinologist;
- Participants aged between 18~75 years;
- Participants with HbA1c ranges from 6.5% to 8.5%;
- Participants with Hamilton Depression Scale (HAMD) (24-item-version) ranges from 20~35 scores;
Key exclusion criteria (9 listed)
- Participants with uncontrolled hypertension (SBP >160mmHg or DBP >100mmHg after taking hypotensive drugs);
- Participants with severe diabetic complications;
- Regular exercisers (at least 20 minutes/time, 3 times/week) in the last 3 months;
- Participants with cognitive impairment (Montreal Cognitive Assessment [MoCA] scores <26);
- Participants with history of bipolar disorder or schizophrenia or other mental illness;
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 Chi24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes). | Behavioural | Tai Chi (1 time/week), Tai Chi (3 times/week), Tai Chi (5 times/week) |
| CBTCBT will be performed once a week for 12 weeks. Each session lasts for 1 hour. | Behavioural | cognitive behavior therapy (CBT) |
Primary outcome
Montgomery Asberg depression rating scale
Time frame: change from baseline to 12 weeks after intervention
9 secondary outcomes
Montgomery Asberg depression rating scale
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Hamilton Depression Scale (HAMD) (24-item-version)
Time frame: change from baseline, after intervention (12 weeks), after follow-up (24 weeks)
Social Disability Screening Schedule
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
EuroQol-5D questionnaire
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Clinical Global Impression scale
Time frame: after intervention (12 weeks), after follow-up (24 weeks)
Biochemical indicators
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Fasting plasma glucose
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Postprandial plasma glucose
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
insulin level
Time frame: baseline, after intervention (12 weeks), after follow-up (24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Youping Liu, PhD study chair
Chengdu University of Traditional Chinese Medicine
3 sites 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 CBT in people with Depression and T2DM, run by Chengdu University of Traditional Chinese Medicine at 3 sites in China.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
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?
Montgomery Asberg depression rating scale (time frame: change from baseline to 12 weeks after intervention). 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 30 Oct 2020.