Condition category
Mental and Behavioural Disorders
Date applied
05/04/2008
Date assigned
01/05/2008
Last edited
05/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shen-Ing Liu

ORCID ID

Contact details

Department of Psychiatry
Mackay Memorial Hospital
No 45
Ming-Shan Road
Tam-Shui
Chu-Wui
Taipei County
25115
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NHRI-EX97-9706PI

Study information

Scientific title

Effectiveness of culturally sensitive collaborative treatment of depressed Chinese people in primary care: a randomised controlled trial

Acronym

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2008

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant 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

Recruitment start date

01/05/2008

Recruitment end date

31/07/2012

Locations

Countries of recruitment

Taiwan

Trial participating centre

Department of Psychiatry
Taipei County
25115
Taiwan

Sponsor information

Organisation

National Health Research Institutes (Taiwan)

Sponsor details

35 Keyan Road
Zhunan
Miaoli County
350
Taiwan

Sponsor type

Government

Website

http://english.nhri.org.tw

Funders

Funder type

Government

Funder name

National Health Research Institutes (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes