Depression, T2DM
Conditions
Keywords
Tai Chi, Depression, T2DM, Randomized Controlled Trial
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.
Interventions
BEHAVIORALTai Chi
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).
BEHAVIORALCBT
CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.
Sponsors
University of Electronic Science and Technology of China
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg depression rating scale | change from baseline to 12 weeks after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index | baseline, after intervention (12 weeks), after follow-up (24 weeks) |
| Hamilton Anxiety Rating Scale | baseline, after intervention (12 weeks), after follow-up (24 weeks) |
Countries
China
Outcome results
None listed