Effectiveness of collaborative care for depressed Chinese people in primary care
| ISRCTN | ISRCTN87321950 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87321950 |
| Secondary identifying numbers | NHRI-EX97-9706PI |
- Submission date
- 05/04/2008
- Registration date
- 01/05/2008
- Last edited
- 04/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shen-Ing Liu
Scientific
Scientific
Department of Psychiatry
Mackay Memorial Hospital
No 45
Ming-Shan Road
Tam-Shui
Chu-Wui
Taipei County
25115
Taiwan
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Effectiveness of culturally sensitive collaborative treatment of depressed Chinese people in primary care: a randomised controlled trial |
| Study objectives | 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(s) | Mackay Memorial Hospital Institutional Review Board. Date of approval: 24/04/2007 (ref: MMH-I-S-241 [2]) |
| Health condition(s) or problem(s) studied | Depressive disorder |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/05/2008 |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Department of Psychiatry
Taipei County
25115
Taiwan
25115
Taiwan
Sponsor information
National Health Research Institutes (Taiwan)
Government
Government
35 Keyan Road
Zhunan
Miaoli County
350
Taiwan
| Website | http://english.nhri.org.tw |
|---|---|
"ROR" |
https://ror.org/02r6fpx29 |
Funders
Funder type
Government
National Health Research Institutes (Taiwan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2018 | Yes | No |
Editorial Notes
04/02/2019: Publication reference added.
