Tai Chi for Comorbid Depression in T2DM Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04609631
• Other study ID #: 2019YFC1710302
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• T2DM

Intervention

Behavioral:
• Tai 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).
• CBT
CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.

Locations

Country	Name	City	State
China	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)	Chengdu	Sichuan
China	Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	Henan University of Chinese Medicine	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh sleep quality index		baseline, after intervention (12 weeks), after follow-up (24 weeks)
Other	Hamilton Anxiety Rating Scale		baseline, after intervention (12 weeks), after follow-up (24 weeks)
Primary	Montgomery Asberg depression rating scale		change from baseline to 12 weeks after intervention
Secondary	Montgomery Asberg depression rating scale		baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	Hamilton Depression Scale (HAMD) (24-item-version)		change from baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	Social Disability Screening Schedule		baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	EuroQol-5D questionnaire		baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	Clinical Global Impression scale		after intervention (12 weeks), after follow-up (24 weeks)
Secondary	Biochemical indicators	HbA1c	baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	Fasting plasma glucose	Biochemical indicators	baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	Postprandial plasma glucose	Biochemical indicators	baseline, after intervention (12 weeks), after follow-up (24 weeks)
Secondary	insulin level	Biochemical indicators	baseline, after intervention (12 weeks), after follow-up (24 weeks)