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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01851967
Other study ID # 2012-P-002340
Secondary ID
Status Completed
Phase N/A
First received January 8, 2013
Last updated November 30, 2016
Start date September 2014
Est. completion date November 2016

Study information

Verified date November 2016
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date November 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
MoodGYM
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.

Locations

Country Name City State
China Ying Wang Beijing
United States Massachusetts General Hospital Depression Clinical and Research Program Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
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