DepressionNCT00227929
Culturally Sensitive Collaborative Treatment for Depressed Chinese Americans
A study testing Care Management in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of culturally sensitive treatment versus regular care in treating depressed Chinese Americans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Care Management
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jun 2008
- 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
- Chinese ethnicity
- Currently depressed as determined by a total score of at least 16 on the CBCI scale
- Speaks and understands English or Chinese (including Mandarin, Cantonese, and Taiwanese dialect)
- Willing to participate in follow-up phone calls
Who cannot join
- Currently at risk for suicide
- Current unstable medical illness
- Current clinical or laboratory evidence of hypothyroidism
- Diagnosed with any of the following in addition to depression: organic mental disorder; schizophrenia; delusional disorder; psychotic disorder; bipolar disorder; mood congruent or mood incongruent psychotic features
- History of treatment by a psychiatrist within 4 months of study entry
- History of alcohol or substance abuse within 1 year of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
South Cove Community Health Center
Boston, Massachusetts, 02111
About this study
Official title: Effectiveness of Culturally Sensitive Collaborative Treatment (CSCT) of Depressed Chinese Americans in Primary Care
This study will evaluate the effectiveness of culturally sensitive treatment versus regular care in treating depressed Chinese Americans.
Read the detailed description
Depression is a complex illness that impacts an individual's thoughts, behavior, mood, and physical health. Research has shown that many Asian Americans with depression do not complain about their symptoms or seek treatment, which has lead to an under-recognition of depression in this population. Furthermore, even when a primary care physician does diagnose depression in an Asian American, adequate treatment does not often follow. There is a clear need to understand the cultural reasons for why treatment is not sought out by Asian Americans. There is also a need for developing new treatments that specifically target the Asian American population. Offering culturally sensitive therapies combined with traditional medical care may make depressed Asian Americans more comfortable in seeking treatment for their illness. Culturally Sensitive Collaborative Treatment (CSCT) is a comprehensive approach to treating depression. It incorporates consultation with a culturally trained psychiatrist, medical treatment provided by a primary care provider, and care management provided by a bilingual and bicultural care manager. The purpose of this study is to evaluate the effectiveness of CSCT versus traditional medical care for the treatment of depression in Chinese Americans.
This 24-week study will enroll depressed Chinese Americans. Potential participants will be interviewed in primary care clinics to screen for depression. Once enrolled, all participants will attend a consultation with a psychiatrist trained in cultural sensitivity to introduce the concept and treatment of depression. Participants will then be randomly assigned to either CSCT or standard care. Both groups of participants will receive regular care from their primary care provider, but the CSCT group will also meet with a bilingual and bicultural care manager to learn how to fully manage their depression. Outcome measurements will include symptoms of depression; adherence to appointments with primary care providers; adherence to medication treatment; and adverse events. All measurements will be assessed during follow-up phone calls at Weeks 2, 6, 10, 14, 18, 22, and 24.
- Conditions
- Depression
- Being tested
- Care Management
- Keywords
- Major Depressive Disorder, MDD
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care ManagementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of depression; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Secondary outcomes (4)
Adherence to clinic visits with the primary care physicians; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Quality of life; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Adherence to medication treatment; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Adverse events; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionSep 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Albert Yeung, Massachusetts General Hospital
- Investigators
- Albert Yeung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227929
- Sponsor's protocol ID
- K23MH067085
- Other IDs
- K23MH067085, DSIR 8K-RTSE
- Status last verified
- Dec 2013
- First submitted
- 26 Sep 2005
- Last updated
- 10 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Culturally Sensitive Collaborative Treatment (CSCT) of Depressed Chinese Americans in Primary Care
- ClinicalTrials.gov ID
- NCT00227929
- Acronym / sponsor ID
- K23MH067085
- Conditions
- Depression
- Keywords
- Major Depressive Disorder, MDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 28 Sep 2005 (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 will evaluate the effectiveness of culturally sensitive treatment versus regular care in treating depressed Chinese Americans.
Detailed description
Depression is a complex illness that impacts an individual's thoughts, behavior, mood, and physical health. Research has shown that many Asian Americans with depression do not complain about their symptoms or seek treatment, which has lead to an under-recognition of depression in this population. Furthermore, even when a primary care physician does diagnose depression in an Asian American, adequate treatment does not often follow. There is a clear need to understand the cultural reasons for why treatment is not sought out by Asian Americans. There is also a need for developing new treatments that specifically target the Asian American population. Offering culturally sensitive therapies combined with traditional medical care may make depressed Asian Americans more comfortable in seeking treatment for their illness. Culturally Sensitive Collaborative Treatment (CSCT) is a comprehensive approach to treating depression. It incorporates consultation with a culturally trained psychiatrist, medical treatment provided by a primary care provider, and care management provided by a bilingual and bicultural care manager. The purpose of this study is to evaluate the effectiveness of CSCT versus traditional medical care for the treatment of depression in Chinese Americans.
This 24-week study will enroll depressed Chinese Americans. Potential participants will be interviewed in primary care clinics to screen for depression. Once enrolled, all participants will attend a consultation with a psychiatrist trained in cultural sensitivity to introduce the concept and treatment of depression. Participants will then be randomly assigned to either CSCT or standard care. Both groups of participants will receive regular care from their primary care provider, but the CSCT group will also meet with a bilingual and bicultural care manager to learn how to fully manage their depression. Outcome measurements will include symptoms of depression; adherence to appointments with primary care providers; adherence to medication treatment; and adverse events. All measurements will be assessed during follow-up phone calls at Weeks 2, 6, 10, 14, 18, 22, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese ethnicity
- Currently depressed as determined by a total score of at least 16 on the CBCI scale
- Speaks and understands English or Chinese (including Mandarin, Cantonese, and Taiwanese dialect)
- Willing to participate in follow-up phone calls
Key exclusion criteria (6 listed)
- Currently at risk for suicide
- Current unstable medical illness
- Current clinical or laboratory evidence of hypothyroidism
- Diagnosed with any of the following in addition to depression: organic mental disorder; schizophrenia; delusional disorder; psychotic disorder; bipolar disorder; mood congruent or mood incongruent psychotic features
- History of treatment by a psychiatrist within 4 months of study entry
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 |
|---|---|---|
| Care Management | Procedure or surgery | – |
Primary outcome
Symptoms of depression; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
4 secondary outcomes
Adherence to clinic visits with the primary care physicians; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Quality of life; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Adherence to medication treatment; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
Adverse events; measured at Weeks 2, 6, 10, 14, 18, 22, and 24
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 10 Dec 2013.
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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.
Albert Yeung, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Management in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
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 4 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Symptoms of depression; measured at Weeks 2, 6, 10, 14, 18, 22, and 24. 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 10 Dec 2013.