NCT01619631

Brief Summary

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) that provides the feasibility, safety, and preliminary efficacy data required to design a large scale trial evaluating Tai Chi for Chinese Americans with major depressive disorder (MDD) who are not on antidepressant medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

June 12, 2012

Last Update Submit

November 30, 2016

Conditions

Depression

Keywords

DepressionTai ChiAlternative medicineMind body medicine

Outcome Measures

Primary Outcomes (2)

  • Major depressive disorder response rate, as determined by Hamilton Rating Scale for Depression (HAM-D 17-item)

    Response will be defined as having a 50% or greater improvement in HAM-D-17 score at the conclusion fo treatment, compared to baseline.

    Baseline, 12-weeks, 24-weeks

  • Major depressive disorder remission as measured by DSM-IV and Hamilton Rating Scale for Depression (HAM-D 17-item)

    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.

    Week 12, week 24

Study Arms (3)

12-week Tai Chi intervention

EXPERIMENTAL
Behavioral: 12-week Tai Chi intervention

Education control group

ACTIVE COMPARATOR

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

Waitlist control group

NO INTERVENTION

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.

Interventions

12-week Tai Chi interventionBEHAVIORAL

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.

12-week Tai Chi intervention
Education control groupBEHAVIORAL

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.

Education control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified as being of Chinese ethnicity and fluent in Mandarin and/or Cantonese
  • years of age
  • Satisfy DSM-IV criteria for MDD
  • Baseline score of 14-20 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17)
  • No regular (≥ 3 times/week for ≥ 2 months) Tai Chi training/practice or other forms of mind-body intervention in the past 6 months

You may not qualify if:

  • Primary psychiatric diagnosis other than MDD
  • History of psychosis, mania, or severe cluster B personality disorder, active ETOH or substance abuse/dependency disorder in the past 6 months
  • Unstable medical conditions as judged by investigators
  • Use or plan to use confounding treatments, including antidepressants and CAM treatments thought to have beneficial effects on mood, such as St. John's Wort, S-Adenosyl methionine (SAMe), omega-3 fatty acids, light therapy, conventional psychotherapy, mind-body interventions (e.g. Qigong, mindfulness training, muscle relaxation training, etc.)
  • Current active suicidal or self-injurious potential necessitating immediate treatment
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South Cove Community Health Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Short KH, Johnston C. Stress, maternal distress, and children's adjustment following immigration: the buffering role of social support. J Consult Clin Psychol. 1997 Jun;65(3):494-503. doi: 10.1037//0022-006x.65.3.494.

    PMID: 9170773BACKGROUND

  • Taylor-Piliae RE, Froelicher ES. Measurement properties of Tai Chi exercise self-efficacy among ethnic Chinese with coronary heart disease risk factors: a pilot study. Eur J Cardiovasc Nurs. 2004 Dec;3(4):287-94. doi: 10.1016/j.ejcnurse.2004.09.001.

    PMID: 15572017BACKGROUND

  • Zhang J, Norvilitis JM. Measuring Chinese psychological well-being with Western developed instruments. J Pers Assess. 2002 Dec;79(3):492-511. doi: 10.1207/S15327752JPA7903_06.

    PMID: 12511017BACKGROUND

  • Yeung AS, Feng R, Kim DJH, Wayne PM, Yeh GY, Baer L, Lee OE, Denninger JW, Benson H, Fricchione GL, Alpert J, Fava M. A Pilot, Randomized Controlled Study of Tai Chi With Passive and Active Controls in the Treatment of Depressed Chinese Americans. J Clin Psychiatry. 2017 May;78(5):e522-e528. doi: 10.4088/JCP.16m10772.

    PMID: 28570792DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Albert Yeung, MD, ScD

    Massachusetts General Hospital Depression Clinical and Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychiatrist

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

US(2)