Tai Chi for Comorbid Depression in T2DM Patients
1 other identifier
interventional
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 30, 2020
October 1, 2020
1.4 years
October 26, 2020
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery Asberg depression rating scale
change from baseline to 12 weeks after intervention
Secondary Outcomes (9)
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)
- +4 more secondary outcomes
Other Outcomes (2)
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)
Study Arms (5)
Tai Chi (5 times/week)
EXPERIMENTAL5 sessions of Tai Chi per week for 12 weeks
Tai Chi (3 times/week)
EXPERIMENTAL3 sessions of Tai Chi per week for 12 weeks
Tai Chi (1 time/week)
EXPERIMENTAL1 session of Tai Chi per week for 12 weeks
cognitive behavior therapy (CBT)
ACTIVE COMPARATOR1 session of CBT per week for 12 weeks
Waiting-list
NO INTERVENTIONParticipants will maintain their routine treatment and life style for 12 weeks.
Interventions
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 will be performed once a week for 12 weeks. Each session lasts for 1 hour.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040, China
Henan University of Chinese Medicine
Zhengzhou, Henan, 450046, China
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
Chengdu, Sichuan, 610075, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Youping Liu, PhD
Chengdu University of Traditional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chengdu University of Traditional Chinese Medicine
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 30, 2020
Study Start
January 1, 2020
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
October 30, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share