Tai Chi Intervention for Chinese Americans With Depression
|ClinicalTrials.gov Identifier: NCT01619631|
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : December 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: 12-week Tai Chi intervention Behavioral: Education control group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tai Chi Intervention for Chinese Americans With Depression|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||November 2016|
|Experimental: 12-week Tai Chi intervention||
Behavioral: 12-week Tai Chi intervention
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.
Active Comparator: Education control group
After 24 weeks, and upon completion of the study, each participant will be offered twelve weeks of Tai Chi twice weekly.
Behavioral: Education control group
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.
No Intervention: Waitlist control group
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.
- Major depressive disorder response rate, as determined by Hamilton Rating Scale for Depression (HAM-D 17-item) [ Time Frame: Baseline, 12-weeks, 24-weeks ]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) [ Time Frame: Week 12, week 24 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619631
|United States, Massachusetts|
|South Cove Community Health Center|
|Boston, Massachusetts, United States, 02111|
|Massachusetts General Hospital Depression Clinical and Research Program|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Albert Yeung, MD, ScD||Massachusetts General Hospital Depression Clinical and Research Program|