Tai Chi for Comorbid Depression in T2DM Patients
Not Applicable
- Conditions
- DepressionT2DM
- Interventions
- Behavioral: Tai ChiBehavioral: CBT
- Registration Number
- NCT04609631
- Lead Sponsor
- Chengdu University of Traditional Chinese Medicine
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tai Chi (1 time/week) Tai Chi 1 session of Tai Chi per week for 12 weeks Tai Chi (5 times/week) Tai Chi 5 sessions of Tai Chi per week for 12 weeks Tai Chi (3 times/week) Tai Chi 3 sessions of Tai Chi per week for 12 weeks cognitive behavior therapy (CBT) CBT 1 session of CBT per week for 12 weeks
- Primary Outcome Measures
Name Time Method Montgomery Asberg depression rating scale change from baseline to 12 weeks after intervention
- Secondary Outcome Measures
Name Time Method 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 baseline, after intervention (12 weeks), after follow-up (24 weeks) HbA1c
Fasting plasma glucose baseline, after intervention (12 weeks), after follow-up (24 weeks) Biochemical indicators
Postprandial plasma glucose baseline, after intervention (12 weeks), after follow-up (24 weeks) Biochemical indicators
insulin level baseline, after intervention (12 weeks), after follow-up (24 weeks) Biochemical indicators
Trial Locations
- Locations (3)
Heilongjiang University of Chinese Medicine
🇨🇳Harbin, Heilongjiang, China
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
🇨🇳Chengdu, Sichuan, China
Henan University of Chinese Medicine
🇨🇳Zhengzhou, Henan, China