NCT01851967

Brief Summary

This study aims to evaluate efficacy and acceptability of the Chinese language version of MoodGYM as a therapeutic intervention in treating symptoms of depression in community dwelling Chinese Americans in the Boston area. Hypothesis 1: Participants enrolled in MoodGYM will show a significant decrease in depressive symptoms after completion of the 5 modules. Hypothesis 2: Participants enrolled in MoodGYM will show significantly improved dysfunctional thinking. Hypothesis 3: Participants enrolled in MoodGym will rate this program as culturally acceptable.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2014

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

January 8, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
11 months 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

1.2 years

First QC Date

January 8, 2013

Last Update Submit

November 30, 2016

Conditions

Keywords

Major depressive disorderCognitive behavioral therapyComputerized CBTOnline CBT

Outcome Measures

Primary Outcomes (1)

  • Change in Center for Epidemiologic Studies Depression Scale (CES-D)

    The CES-D scale is a short self-report scale designed to measure depressive symptomatology in the general population. Each of the 20 items in this instrument is assigned one value of 0, 1, 2 or 3. High scores on the CES-D indicate high levels of distress.

    Weeks 0, 6 (pre/post)

Study Arms (1)

MoodGYM

EXPERIMENTAL

This study is a single-arm intervnetion. All subjects will be assigned to receive six weeks of online CBT through MoodGYM.

Other: MoodGYM

Interventions

MoodGYMOTHER

MoodGYM, a publicly-available online CBT program developed by the Centre for Mental Health Research at The Australian National University has been shown by multiple studies to be effective in reducing symptoms of depression. MoodGYM consists of five interactive modules. Participants will be asked to complete one module each week and progress through the program sequentially.

MoodGYM

Eligibility Criteria

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

You may qualify if:

  • Resident of the US, but self-identified as Chinese origin
  • At least 18 years of age
  • Proficiency in Chinese, including the ability to read Chinese
  • Access to computer and internet
  • Scores \> 10 on the Chinese bilingual patient health questionnaire -9 item (PHQ-9)

You may not qualify if:

  • Current ongoing psychiatric or psychological treatment
  • Using illicit drugs or consumption \> 3 standard drinks in a day
  • Currently experiencing a psychotic illness
  • Past or current history of schizophrenia or bipolar disorder
  • ECT during the last year
  • Current active suicidal or self-injurious potential necessitating immediate face-to-face treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

Ying Wang

Beijing, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator / Psychiatrist

Study Record Dates

First Submitted

January 8, 2013

First Posted

May 13, 2013

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

November 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations