Tai Chi for Comorbid Depression in T2DM Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; T2DM
• Intervention / Treatment: Behavioral: Tai Chi; Behavioral: CBT

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Heilongjiang University of Chinese Medicine
  • Henan
    • Zhengzhou, Henan, China, 450046
      • Henan University of Chinese Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi (5 times/week); 5 sessions of Tai Chi per week for 12 weeks	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).
Experimental: Tai Chi (3 times/week); 3 sessions of Tai Chi per week for 12 weeks	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).
Experimental: Tai Chi (1 time/week); 1 session of Tai Chi per week for 12 weeks	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).
Active Comparator: cognitive behavior therapy (CBT); 1 session of CBT per week for 12 weeks	Behavioral: CBT; CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.
No Intervention: Waiting-list; Participants will maintain their routine treatment and life style for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Collaborators: University of Electronic Science and Technology of China
• Investigators: Study Chair: Youping Liu, PhD, Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Tai Chi; Randomized Controlled Trial; T2DM
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2019YFC1710302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No