DepressionNCT00664885
Effectiveness of Cultural Sensitive Collaborative Treatment of Depressed Chinese
A study testing Culturally Sensitive Collaborative Treatment in people with Depression, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is a randomized controlled trial to test whether Culturally Sensitive Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting non-psychiatric settings in Taiwan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Culturally Sensitive Collaborative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2012
- 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
- Patients who attend non-psychiatric clinics at the above site.
- Patients with Major Depressive Disorder (MDD), defined as a positive screen using the PHQ-9, confirmed with the SCAN interview.
- Men or women aged 18 or older.
- Able to participate in a clinical diagnostic interview in either Mandarin or Fukienese dialects.
- Individuals who are willing to be followed up concerning their depression symptoms.
- Individuals who have completed a written consent form.
Who cannot join
- Women who are pregnant, breast-feeding, or planning pregnancy within the next year.
- Patients with serious suicidal risk.
- Patients with unstable medical illnesses.
- Clinical or laboratory evidence of hypothyroidism.
- Patients with comorbid severe mental disorders
- Patients with history of treatment by a psychiatrist in the past 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cultural Sensitive Collaborative Treatment of Depressed Chinese in Primary Care
This study is a randomized controlled trial to test whether Culturally Sensitive Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting non-psychiatric settings in Taiwan.
- Conditions
- Depression
- Being tested
- Culturally Sensitive Collaborative Treatment
- Keywords
- non-psychiatric, clinics
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Sensitive Collaborative TreatmentOther
a collaborative care model, for treating depressed patients in general medical care
| Study group | Role | What they receive |
|---|---|---|
| CSCT | Experimental | Not described Receives: Other: Culturally Sensitive Collaborative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressed patients who receive CSCT have improved treatment outcomes compared to patients who receive usual care.
Measured: 2wk,6 wk,10 wk,14 wk,18 wk,22wk,26wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2012
- Study completionDec 2012
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Shen-Ing,Liu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664885
- Sponsor's protocol ID
- NHRI-EX97-9706PI
- Status last verified
- Jan 2014
- First submitted
- 18 Apr 2008
- Last updated
- 9 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cultural Sensitive Collaborative Treatment of Depressed Chinese in Primary Care
- ClinicalTrials.gov ID
- NCT00664885
- Acronym / sponsor ID
- NHRI-EX97-9706PI
- Conditions
- Depression
- Keywords
- non-psychiatric, clinics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jan 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Apr 2008 (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 is a randomized controlled trial to test whether Culturally Sensitive Collaborative Treatment (CSCT) would improve the outcome of depressed patients visiting non-psychiatric settings in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSCT | Experimental | Other: Culturally Sensitive Collaborative Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who attend non-psychiatric clinics at the above site.
- Patients with Major Depressive Disorder (MDD), defined as a positive screen using the PHQ-9, confirmed with the SCAN interview.
- Men or women aged 18 or older.
- Able to participate in a clinical diagnostic interview in either Mandarin or Fukienese dialects.
- Individuals who are willing to be followed up concerning their depression symptoms.
Key exclusion criteria (6 listed)
- Women who are pregnant, breast-feeding, or planning pregnancy within the next year.
- Patients with serious suicidal risk.
- Patients with unstable medical illnesses.
- Clinical or laboratory evidence of hypothyroidism.
- Patients with comorbid severe mental disorders
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 |
|---|---|---|
| Culturally Sensitive Collaborative Treatmenta collaborative care model, for treating depressed patients in general medical care | Other | CSCT |
Primary outcome
Depressed patients who receive CSCT have improved treatment outcomes compared to patients who receive usual care.
Time frame: 2wk,6 wk,10 wk,14 wk,18 wk,22wk,26wk
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 9 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Sensitive Collaborative Treatment in people with Depression, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 6 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 9 Jan 2014. 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 Taiwan. 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?
Depressed patients who receive CSCT have improved treatment outcomes compared to patients who receive usual care. (time frame: 2wk,6 wk,10 wk,14 wk,18 wk,22wk,26wk). 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 9 Jan 2014.