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07 August 2008
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| [ Print-friendly version ] |
| Effectiveness of collaborative care for depressed Chinese people in primary care |
| ISRCTN | ISRCTN87321950 |
| ClinicalTrials.gov identifier | |
| Public title | Effectiveness of collaborative care for depressed Chinese people in primary care |
| Scientific title | Effectiveness of culturally sensitive collaborative treatment of depressed Chinese people in primary care: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | NHRI-EX97-9706PI |
| Study hypothesis |
1. Depressed patients who receive intervention have improved treatment outcomes compared to patients who receive usual care
2. Depressed patients who perceive biomedical causes of depression have improved treatment outcomes compared to patients who perceive non-medical causes of depression 3. Depressed patients with history of seeking medical treatment have improved treatment outcomes compared to patients with history of seeking non-medical treatment 4. Depressed patients with low stigmatisation have improved treatment outcomes compared to patients with high stigmatisation |
| Ethics approval | Mackay Memorial Hospital Institutional Review Board. Date of approval: 24/04/2007 (ref: MMH-I-S-241 [2]) |
| Study design | Randomised controlled trial. |
| Countries of recruitment | Taiwan |
| Disease/condition/study domain | Depressive disorder |
| Participants - inclusion criteria |
1. Patients who attend non-psychiatric clinics
2. Patients with Major Depressive Disorder (MDD), defined as a positive screen using the Patient Health Questionnaire (PHQ-9), confirmed with the Schedules of Clinical Assessment in Neuropsychiatry (SCAN) interview 3. Men or women aged 18 or older 4. Able to participate in a clinical diagnostic interview in either Mandarin or Fukienese dialects 5. Individuals who are willing to be followed up concerning their depression symptoms 6. Individuals who have completed a written consent form |
| Participants - exclusion criteria |
1. Women who are pregnant, breast-feeding or planning pregnancy within the next year
2. Patients with serious suicidal risk 3. Patients with unstable medical illnesses 4. Clinical or laboratory evidence of hypothyroidism 5. Patients with comorbid severe mental disorders including: 5.1. Organic mental disorders 5.2. Alcohol or substance abuse disorders active within the last year 5.3. Schizophrenia 5.4. Delusional disorder 5.5. Psychotic disorders not elsewhere classified 5.6. Bipolar disorder 5.7. Mood congruent or mood incongruent psychotic features 6. Patients with history of treatment by a psychiatrist in the past 4 months |
| Anticipated start date | 01/05/2008 |
| Anticipated end date | 31/07/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 400 |
| Interventions |
The intervention includes consultation to depressed patients by a psychiatrist, treatment of depression by general medical doctors based on established guidelines, and Care Management by a Care Manager under the supervision of a psychiatrist.
The control group of participants will receive the "standard care." Duration of interventions: 24 weeks |
| Primary outcome measure(s) | Rate of adherence to treatment initiation, assessed by blind assessors at baseline and every four weeks from week 2 until week 26 or end point. |
| Secondary outcome measure(s) |
The following will be assessed by blind assessors at baseline and every four weeks from week 2 until week 26 or end point:
1. Rate of adherence to medication treatment 2. Rate of treatment completers 3. Rate of responders 4. Overall life satisfaction |
| Sources of funding | National Health Research Institutes (Taiwan) |
| Trial website | |
| Publications | |
| Contact name | Dr Shen-Ing Liu |
| Address |
Department of Psychiatry
Mackay Memorial Hospital No 45 Ming-Shan Road Tam-Shui Chu-Wui |
| City/town | Taipei County |
| Zip/Postcode | 25115 |
| Country | Taiwan |
| Sponsor | National Health Research Institutes (Taiwan) |
| Address |
35 Keyan Road
Zhunan |
| City/town | Miaoli County |
| Zip/Postcode | 350 |
| Country | Taiwan |
| Sponsor website: | http://english.nhri.org.tw |
| Date applied | 05/04/2008 |
| Last edited | 05/08/2008 |
| Date ISRCTN assigned | 01/05/2008 |
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