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Tai Chi for Comorbid Depression in T2DM Patients

Primary Purpose

Depression, T2DM

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tai Chi
CBT
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Tai Chi, Depression, T2DM, Randomized Controlled Trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heilongjiang University of Chinese Medicine
  • Henan University of Chinese Medicine
  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Tai Chi (5 times/week)

Tai Chi (3 times/week)

Tai Chi (1 time/week)

cognitive behavior therapy (CBT)

Waiting-list

Arm Description

5 sessions of Tai Chi per week for 12 weeks

3 sessions of Tai Chi per week for 12 weeks

1 session of Tai Chi per week for 12 weeks

1 session of CBT per week for 12 weeks

Participants will maintain their routine treatment and life style for 12 weeks.

Outcomes

Primary Outcome Measures

Montgomery Asberg depression rating scale

Secondary Outcome Measures

Montgomery Asberg depression rating scale
Hamilton Depression Scale (HAMD) (24-item-version)
Social Disability Screening Schedule
EuroQol-5D questionnaire
Clinical Global Impression scale
Biochemical indicators
HbA1c
Fasting plasma glucose
Biochemical indicators
Postprandial plasma glucose
Biochemical indicators
insulin level
Biochemical indicators

Full Information

First Posted
October 26, 2020
Last Updated
October 29, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
University of Electronic Science and Technology of China
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1. Study Identification

Unique Protocol Identification Number
NCT04609631
Brief Title
Tai Chi for Comorbid Depression in T2DM Patients
Official Title
Tai Chi for Comorbid Depression in T2DM Patients: A Randomized Controlled Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
University of Electronic Science and Technology of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, T2DM
Keywords
Tai Chi, Depression, T2DM, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi (5 times/week)
Arm Type
Experimental
Arm Description
5 sessions of Tai Chi per week for 12 weeks
Arm Title
Tai Chi (3 times/week)
Arm Type
Experimental
Arm Description
3 sessions of Tai Chi per week for 12 weeks
Arm Title
Tai Chi (1 time/week)
Arm Type
Experimental
Arm Description
1 session of Tai Chi per week for 12 weeks
Arm Title
cognitive behavior therapy (CBT)
Arm Type
Active Comparator
Arm Description
1 session of CBT per week for 12 weeks
Arm Title
Waiting-list
Arm Type
No Intervention
Arm Description
Participants will maintain their routine treatment and life style for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.
Primary Outcome Measure Information:
Title
Montgomery Asberg depression rating scale
Time Frame
change from baseline to 12 weeks after intervention
Secondary Outcome Measure Information:
Title
Montgomery Asberg depression rating scale
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
Hamilton Depression Scale (HAMD) (24-item-version)
Time Frame
change from baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
Social Disability Screening Schedule
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
EuroQol-5D questionnaire
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
Clinical Global Impression scale
Time Frame
after intervention (12 weeks), after follow-up (24 weeks)
Title
Biochemical indicators
Description
HbA1c
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
Fasting plasma glucose
Description
Biochemical indicators
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
Postprandial plasma glucose
Description
Biochemical indicators
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
insulin level
Description
Biochemical indicators
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Other Pre-specified Outcome Measures:
Title
Pittsburgh sleep quality index
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)
Title
Hamilton Anxiety Rating Scale
Time Frame
baseline, after intervention (12 weeks), after follow-up (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youping Liu, PhD
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Henan University of Chinese Medicine
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450046
Country
China
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Tai Chi for Comorbid Depression in T2DM Patients

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