NCT01263730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

2.5 years

First QC Date

December 6, 2010

Last Update Submit

April 18, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 weeks of Tai Chi Training

Secondary Outcomes (1)

  • Psychological questionnaires, specifically the Quality of Life Enjoyment questionnaire.

    12 weeks of Tai Chi Training

Study Arms (2)

Tai Chi Training

ACTIVE COMPARATOR

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

Behavioral: Tai Chi

Waitlist control group

NO INTERVENTION

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

Interventions

Tai ChiBEHAVIORAL

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.

Tai Chi Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Cove

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Albert Yeung, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
  • John W. Denninger, MD

    Massachusetts General Hospital

    STUDY DIRECTOR
  • Herbert Benson, MD

    Massachusetts General Hospital

    STUDY DIRECTOR
  • Gregory Fricchione, MD

    Massachusetts General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 21, 2010

Study Start

February 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations