Tai Chi Training for Treating Depressed Chinese Americans

This study has been completed.
Sponsor:
Collaborator:
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

December 6, 2010
April 18, 2012
February 2008
August 2010   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01263730 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Tai Chi Training for Treating Depressed Chinese Americans
Tai Chi Training for Treating Depressed Chinese Americans

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Major Depressive Disorder
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.
  • Active Comparator: Tai Chi Training
    The active group will be given 12 weeks of tai chi training
    Intervention: Behavioral: Tai Chi
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01263730
2008P000262
No
Albert Yeung, Massachusetts General Hospital
Massachusetts General Hospital
Centers for Disease Control and Prevention
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
Massachusetts General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP