NCT00664885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

4.2 years

First QC Date

April 18, 2008

Last Update Submit

January 8, 2014

Conditions

Depression

Keywords

non-psychiatricclinics

Outcome Measures

Primary Outcomes (1)

  • Depressed patients who receive CSCT have improved treatment outcomes compared to patients who receive usual care.

    2wk,6 wk,10 wk,14 wk,18 wk,22wk,26wk

Study Arms (1)

CSCT

EXPERIMENTAL
Other: Culturally Sensitive Collaborative Treatment

Interventions

Culturally Sensitive Collaborative TreatmentOTHER

a collaborative care model, for treating depressed patients in general medical care

CSCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, 251, Taiwan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Psychiatry

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 23, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

TW(1)