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Tai Chi Training for Treating Depressed Chinese Americans

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • South Cove

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Tai Chi Training

Waitlist control group

Arm Description

The active group will be given 12 weeks of tai chi training

There is a waitlist control group that will receive the training following a 12 week no treatment period of time

Outcomes

Primary Outcome Measures

Depressive Symptoms
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.
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.

Full Information

First Posted
December 6, 2010
Last Updated
April 18, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01263730
Brief Title
Tai Chi Training for Treating Depressed Chinese Americans
Official Title
Tai Chi Training for Treating Depressed Chinese Americans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi Training
Arm Type
Active Comparator
Arm Description
The active group will be given 12 weeks of tai chi training
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
There is a waitlist control group that will receive the training following a 12 week no treatment period of time
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive Symptoms
Description
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).
Time Frame
12 weeks of Tai Chi Training
Secondary Outcome Measure Information:
Title
Psychological questionnaires, specifically the Quality of Life Enjoyment questionnaire.
Description
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.
Time Frame
12 weeks of Tai Chi Training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Yeung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John W. Denninger, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Herbert Benson, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gregory Fricchione, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
South Cove
City
Boston
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

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Tai Chi Training for Treating Depressed Chinese Americans

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