Tai Chi for Comorbid Depression in T2DM Patients

Study Overview
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Brief Summary
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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.

Official Title
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Tai Chi for Comorbid Depression in T2DM Patients: A Randomized Controlled Trial Protocol

Conditions
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Depression, T2DM

Intervention / Treatment
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* Behavioral: Tai Chi
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 (5 times/week)<br>5 sessions of Tai Chi per week for 12 weeks | Behavioral: Tai Chi<br>* 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).<br>|
| Experimental: Tai Chi (3 times/week)<br>3 sessions of Tai Chi per week for 12 weeks | Behavioral: Tai Chi<br>* 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).<br>|
| Experimental: Tai Chi (1 time/week)<br>1 session of Tai Chi per week for 12 weeks | Behavioral: Tai Chi<br>* 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).<br>|
| Active Comparator: cognitive behavior therapy (CBT)<br>1 session of CBT per week for 12 weeks | Behavioral: CBT<br>* CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.<br>|
| No Intervention: Waiting-list<br>Participants will maintain their routine treatment and life style for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg depression rating scale |  | change from baseline to 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg depression rating scale |  | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| Hamilton Depression Scale (HAMD) (24-item-version) |  | change from baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| Social Disability Screening Schedule |  | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| EuroQol-5D questionnaire |  | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| Clinical Global Impression scale |  | after intervention (12 weeks), after follow-up (24 weeks) | 
| Biochemical indicators | HbA1c | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| Fasting plasma glucose | Biochemical indicators | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| Postprandial plasma glucose | Biochemical indicators | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 
| insulin level | Biochemical indicators | baseline, after intervention (12 weeks), after follow-up (24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, Tai Chi, Depression, Randomized Controlled Trial