Major Depressive DisorderNCT01851967
Effectiveness and Acceptability of MoodGYM in Treating Depressive Symptoms in Chinese Americans
A study testing MoodGYM in people with Major Depressive Disorder, run by Massachusetts General Hospital at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- MoodGYM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Massachusetts General Hospital Depression Clinical and Research Program
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Major Depressive Disorder
- Being tested
- MoodGYM
- Keywords
- Major depressive disorder, Cognitive behavioral therapy, Computerized CBT, Online CBT
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MoodGYM | Experimental | This study is a single-arm intervnetion. All subjects will be assigned to receive six weeks of online CBT through MoodGYM. Receives: Other: MoodGYM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0, 6 (pre/post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Yeung, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851967
- Sponsor's protocol ID
- 2012-P-002340
- Status last verified
- Nov 2016
- First submitted
- 8 Jan 2013
- Last updated
- 1 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Acceptability of MoodGYM in Treating Depressive Symptoms in Chinese Americans
- ClinicalTrials.gov ID
- NCT01851967
- Acronym / sponsor ID
- 2012-P-002340
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Cognitive behavioral therapy, Computerized CBT, Online CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MoodGYM | Experimental | Other: MoodGYMThis study is a single-arm intervnetion. All subjects will be assigned to receive six weeks of online CBT through MoodGYM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoodGYMMoodGYM, 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. | Other | MoodGYM |
Primary outcome
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Weeks 0, 6 (pre/post)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoodGYM in people with Major Depressive Disorder, run by Massachusetts General Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center for Epidemiologic Studies Depression Scale (CES-D) (time frame: Weeks 0, 6 (pre/post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.