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Tai Chi Training for Treating Depressed Chinese Americans

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Albert Yeung, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01263730
First received: December 6, 2010
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

The goal of this research is to evaluate whether Tai Chi merits further investigation as a non-pharmacological therapy in the treatment of Major Depressive Disorder (MDD). Specifically, this waitlist-controlled study will gather preliminary data evaluating the effectiveness of Tai Chi training as treatment for patients with MDD or a history of MDD, including patients who continue to be depressed despite taking antidepressants and patients who choose not to take antidepressants due to fear of side effects and/or for personal reasons. To test this hypothesis the investigators will compare physical and psychological parameters of a control group and an intervention group, at baseline (Week 0), at the midpoint (Week 6), and at the end of 12 weeks of Tai Chi training.


Condition Intervention
Major Depressive Disorder
 Behavioral: Tai Chi

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Tai Chi Training for Treating Depressed Chinese Americans

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Depressive Symptoms [ Time Frame: 12 weeks of Tai Chi Training ] [ Designated as safety issue: Yes ]
    We will be looking for a decrease in depressive symptoms at the mid- (week 6) and post- (week 12) time point following Tai Chi training as compared to the baseline (week 0).


Secondary Outcome Measures:
  • Psychological questionnaires, specifically the Quality of Life Enjoyment questionnaire. [ Time Frame: 12 weeks of Tai Chi Training ] [ Designated as safety issue: Yes ]
    We will compare psychometric questionnaire results pre-(wk 0), mid- (wk 6), and post- (wk 12) Tai Chi training. The questionnaires administered include the Hamilton Depression Rating Scale, Clinical Global Inventory, Patient Health Questionnaire, Beck Depression Inventory, Quality of Life Enjoyment and Satisfaction, Expectations Tai Chi training on depression, International Physical Activity, and Mimet's Multidimensional Scale of Perceived Social Support.


Enrollment: 38
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tai Chi Training
The active group will be given 12 weeks of tai chi training
 Behavioral: Tai Chi
Tai Chi training consists of a sequence of slow, soft, and graceful movements derived from the martial arts. It is considered as a moving form of yoga and meditation combined. Tai Chi has been considered as one form of oriental healing arts, like acupuncture, which fosters the circulation of this 'chi' or energy within the body.
No Intervention: Waitlist control group
There is a waitlist control group that will receive the training following a 12 week no treatment period of time

Detailed Description:

When a first line treatment for depression fails, clinicians often choose to increase the dosage, or augment with a second agent, prior to considering switching agents altogether (Rosenbaum et al, 1995). Combination of an SSRI/SNRI with other agents such as tricyclic antidepressants (TCAs) or lithium are examples of popular strategies (Fava et al, 1994). In many instances, augmentation with multiple psychotropic agents may not be desirable, because of risk of side effects or drug-drug interactions.

In view of their benign adverse effect profiles, non-pharmacological interventions such as psychotherapy and mind-body intervention have been used to augment treatment for treatment resistant depressed patients. Preliminary studies have shown that meditation is beneficial for the treatment of depression (Smith et al., 2007; Sephton et al., 2007; Finucane and Mercer, 2006; Astin et al., 2003; Speca et al., 2000).

Tai Chi training consists of a sequence of slow, soft, and graceful movements derived from the martial arts. It is considered as a moving form of yoga and meditation combined. Tai Chi has been considered as one form of oriental healing arts, like acupuncture, which fosters the circulation of this 'chi' or energy within the body. By doing so, the health and vitality of the person are enhanced. Tai Chi, with its slow movement synchronized to the person's breathing, has been known to lead to a calm and tranquil mind when the person is focused on the precise execution of these exercises.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

General Inclusion criteria

  • Men and women between the ages of 18 and 65 years;
  • Satisfy DSM-IV criteria for current Major Depressive Disorder (MDD), or have a history of MDD, prior to the initiation of Tai Chi treatment, as determined by the SCID interview;
  • Have not had Tai Chi treatment training and have not started other forms of mind/body intervention in the past 3 months.

General Exclusion criteria

  • Patients with primary diagnosis other than MDD and/or do not have a history of MDD;
  • Conditions that may make it difficult to conclusively determine that depressive symptoms are the result of MDD or having a history of MDD and not some other condition, including any form of substance abuse or dependence within the last 6 months, relevant medical conditions that may be the medical basis of a depression including epilepsy, history of an abnormal EEG, severe head trauma, or stroke;
  • Medical conditions that would preclude entry into a clinical trial, including serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that have not been stable for a minimum of 3 months);
  • Confounding treatments, such as current ongoing treatment other than what is provided by South Cove for depression; plans to receive confounding treatments.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263730

Locations
United States, Massachusetts
South Cove
Boston, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Albert Yeung, MD Massachusetts General Hospital
Study Director: John W. Denninger, MD Massachusetts General Hospital
Study Director: Herbert Benson, MD Massachusetts General Hospital
Study Director: Gregory Fricchione, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Albert Yeung, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263730     History of Changes
Other Study ID Numbers: 2008P000262
Study First Received: December 6, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 21, 2013