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Tai Chi Intervention for Chinese Americans With Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week Tai Chi intervention
Education control group
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Tai Chi, Alternative medicine, Mind body medicine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Self-identified as being of Chinese ethnicity and fluent in Mandarin and/or Cantonese
  • 18-80 years of age
  • Satisfy DSM-IV criteria for MDD
  • Baseline score of 14-20 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17)
  • No regular (≥ 3 times/week for ≥ 2 months) Tai Chi training/practice or other forms of mind-body intervention in the past 6 months

Exclusion Criteria:

  • Primary psychiatric diagnosis other than MDD
  • History of psychosis, mania, or severe cluster B personality disorder, active ETOH or substance abuse/dependency disorder in the past 6 months
  • Unstable medical conditions as judged by investigators
  • Use or plan to use confounding treatments, including antidepressants and CAM treatments thought to have beneficial effects on mood, such as St. John's Wort, S-Adenosyl methionine (SAMe), omega-3 fatty acids, light therapy, conventional psychotherapy, mind-body interventions (e.g. Qigong, mindfulness training, muscle relaxation training, etc.)
  • Current active suicidal or self-injurious potential necessitating immediate treatment
  • Women who are pregnant

Sites / Locations

  • South Cove Community Health Center
  • Massachusetts General Hospital Depression Clinical and Research Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

12-week Tai Chi intervention

Education control group

Waitlist control group

Arm Description

After 24 weeks, and upon completion of the study, each participant will be offered twelve weeks of Tai Chi twice weekly.

The waitlist control will not receive any intervention during the duration of the study. After 24 weeks, and upon completion of the study, each participant will be offered twelve weeks of Tai Chi twice weekly.

Outcomes

Primary Outcome Measures

Major depressive disorder response rate, as determined by Hamilton Rating Scale for Depression (HAM-D 17-item)
Response will be defined as having a 50% or greater improvement in HAM-D-17 score at the conclusion fo treatment, compared to baseline.
Major depressive disorder remission as measured by DSM-IV and Hamilton Rating Scale for Depression (HAM-D 17-item)
Remission will require jointly the absence of the core symptoms of depression, with neither of the core features of DSM-IV depression (depressed mood or anhedonia) being reported at the threshold or subthershold level (using Chinese Bilingual SCID I/P interview) and HAM-D-17 score <8.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2012
Last Updated
November 30, 2016
Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01619631
Brief Title
Tai Chi Intervention for Chinese Americans With Depression
Official Title
Tai Chi Intervention for Chinese Americans With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to conduct a pilot randomized controlled trial (RCT) that provides the feasibility, safety, and preliminary efficacy data required to design a large scale trial evaluating Tai Chi for Chinese Americans with major depressive disorder (MDD) who are not on antidepressant medications.
Detailed Description
Aim #1: To evaluate the feasibility and safety of conducting a RCT of Tai Chi for Chinese American adults with MDD who are not on antidepressant medications. The investigators hypothesize that: a) the investigators can develop a Tai Chi intervention and depression-related measurement protocol for Chinese Americans with MDD; b) the investigators will be able to recruit non-pharmacologically treated Chinese Americans with MDD to participate in a randomized controlled Tai Chi study; c) participants will be compliant with the Tai Chi intervention and all testing protocols; d) the Tai Chi intervention will be safe and study staff will be able to effectively monitor participants' depressive symptoms and assure their safety during the study. Aim #2: To collect preliminary data on the efficacy of a 12-week Tai Chi group intervention for Chinese Americans with MDD who are not on antidepressant medications to determine the effect size needed for a definitive RCT. The investigators hypothesize that at the conclusion of 12-weeks, Tai Chi participants, as compared to control subjects, will demonstrate a) greater improvement in depressive symptoms (Hamilton Depression Severity Index-17, Beck Depression Inventory), b) greater improvement in functional status, general health, and well being (Clinical Global Impressions Scale, The SF-36 Health Survey (SF-36®) for social functioning, Exercise Self-Efficacy, Mindfulness), and c) greater social support (Multidimensional Scale of Perceived Social Support). Aim #3: To characterize participants' experience in a trial of Tai Chi for Chinese Americans with MDD in order to optimally design a subsequent, more definitive study. Using mixed methods (qualitative and quantitative analyses), the investigators will identify the ethnocultural experience of Tai Chi among Chinese Americans with MDD, assess whether they view Tai Chi a more culturally acceptable alternative to conventional antidepressant therapy, explore the facilitators and barriers to adherence to the Tai Chi training protocol, identify characteristics of responders and non-responders to the Tai Chi intervention, and assess participants' willingness/intention to continue practice of Tai Chi beyond the study period. The investigators hypothesize that a) characteristics such as severity of illness, age, co-morbidities, and education level may distinguish responders from non-responders; b) participants with greater levels of class attendance and home practice will exhibit greater improvements in depressive symptoms; and c) participants who continue to practice Tai Chi after the 12-week training will maintain clinical improvements in depressive symptoms and a lower rate of relapse at the end of 3 additional months of follow-up compared to those who do not continue Tai Chi practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Tai Chi, Alternative medicine, Mind body medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12-week Tai Chi intervention
Arm Type
Experimental
Arm Title
Education control group
Arm Type
Active Comparator
Arm Description
After 24 weeks, and upon completion of the study, each participant will be offered twelve weeks of Tai Chi twice weekly.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
The waitlist control will not receive any intervention during the duration of the study. After 24 weeks, and upon completion of the study, each participant will be offered twelve weeks of Tai Chi twice weekly.
Intervention Type
Behavioral
Intervention Name(s)
12-week Tai Chi intervention
Intervention Description
Tai Chi classes will be conducted weekly for one hour each for 12 weeks. Classes will begin with warm-up exercises designed to loosen the body, increase awareness of alignment and structural integration, improve efficiency of breathing, incorporate mindfulness and imagery into movement.
Intervention Type
Behavioral
Intervention Name(s)
Education control group
Intervention Description
The education control group will meet twice weekly for 12 weeks for one hour, and research staff will present didactic information modified from psychoeducation curriculums created by the Benson Henry Institute and a stress reduction study for depressed minority patients.
Primary Outcome Measure Information:
Title
Major depressive disorder response rate, as determined by Hamilton Rating Scale for Depression (HAM-D 17-item)
Description
Response will be defined as having a 50% or greater improvement in HAM-D-17 score at the conclusion fo treatment, compared to baseline.
Time Frame
Baseline, 12-weeks, 24-weeks
Title
Major depressive disorder remission as measured by DSM-IV and Hamilton Rating Scale for Depression (HAM-D 17-item)
Description
Remission will require jointly the absence of the core symptoms of depression, with neither of the core features of DSM-IV depression (depressed mood or anhedonia) being reported at the threshold or subthershold level (using Chinese Bilingual SCID I/P interview) and HAM-D-17 score <8.
Time Frame
Week 12, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-identified as being of Chinese ethnicity and fluent in Mandarin and/or Cantonese 18-80 years of age Satisfy DSM-IV criteria for MDD Baseline score of 14-20 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) No regular (≥ 3 times/week for ≥ 2 months) Tai Chi training/practice or other forms of mind-body intervention in the past 6 months Exclusion Criteria: Primary psychiatric diagnosis other than MDD History of psychosis, mania, or severe cluster B personality disorder, active ETOH or substance abuse/dependency disorder in the past 6 months Unstable medical conditions as judged by investigators Use or plan to use confounding treatments, including antidepressants and CAM treatments thought to have beneficial effects on mood, such as St. John's Wort, S-Adenosyl methionine (SAMe), omega-3 fatty acids, light therapy, conventional psychotherapy, mind-body interventions (e.g. Qigong, mindfulness training, muscle relaxation training, etc.) Current active suicidal or self-injurious potential necessitating immediate treatment Women who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Yeung, MD, ScD
Organizational Affiliation
Massachusetts General Hospital Depression Clinical and Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Cove Community Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital Depression Clinical and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9170773
Citation
Short KH, Johnston C. Stress, maternal distress, and children's adjustment following immigration: the buffering role of social support. J Consult Clin Psychol. 1997 Jun;65(3):494-503. doi: 10.1037//0022-006x.65.3.494.
Results Reference
background
PubMed Identifier
15572017
Citation
Taylor-Piliae RE, Froelicher ES. Measurement properties of Tai Chi exercise self-efficacy among ethnic Chinese with coronary heart disease risk factors: a pilot study. Eur J Cardiovasc Nurs. 2004 Dec;3(4):287-94. doi: 10.1016/j.ejcnurse.2004.09.001.
Results Reference
background
PubMed Identifier
12511017
Citation
Zhang J, Norvilitis JM. Measuring Chinese psychological well-being with Western developed instruments. J Pers Assess. 2002 Dec;79(3):492-511. doi: 10.1207/S15327752JPA7903_06.
Results Reference
background
PubMed Identifier
28570792
Citation
Yeung AS, Feng R, Kim DJH, Wayne PM, Yeh GY, Baer L, Lee OE, Denninger JW, Benson H, Fricchione GL, Alpert J, Fava M. A Pilot, Randomized Controlled Study of Tai Chi With Passive and Active Controls in the Treatment of Depressed Chinese Americans. J Clin Psychiatry. 2017 May;78(5):e522-e528. doi: 10.4088/JCP.16m10772.
Results Reference
derived

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Tai Chi Intervention for Chinese Americans With Depression

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