Condition category
Mental and Behavioural Disorders
Date applied
01/12/2006
Date assigned
01/12/2006
Last edited
23/08/2012
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

Ms M C Vlasveld

ORCID ID

Contact details

Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2959303
mvlasveld@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CC:DOC

Study hypothesis

A collaborative care intervention for patients with major depressive disorder who are on sick leave will result in more reduction in depressive symptoms and a faster return to work than usual care.

Ethics approval

Ethics approval received from the Ethics Committee of the VUmc (METc, VUmc, Amsterdam) on the 3rd August 2007 (ref: 2006/246).

Study design

Randomised controlled parallel armed trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depressive disorders

Intervention

The intervention follows a collaborative care model with adherence and compliance enhancing techniques, contracting, Problem Solving Treatment (PST), antidepressant medication, a workplace intervention, and manual guided self help aimed at return to work and healthy lifestyle.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the extent of reduction in depressive symptoms, as measured by the PHQ-9.

Secondary outcome measures

The secondary outcome measure is time to return to work, which will be acquired upon inquiry with company doctor and patient and which refers to the duration of absence through illness until work is resumed.

Overall trial start date

01/03/2007

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Employees on sick leave lasting between 4 to 12 weeks with major depressive disorder and who do not have the prospect of full return to work yet.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

126

Participant exclusion criteria

1. Patients who are suicidal, psychotic or have dementia, as noticed by the company doctor
2. Addicted to drugs or alcohol, as assessed by the Mini International Neuropsychiatric Interview (MINI)
3. Patients who do not speak Dutch sufficiently to fill in the questionnaires

Patients who are already receiving psychiatric treatment can be included in the study, in case of mutual agreement with the current care giver.

Recruitment start date

01/03/2007

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos-institute/Netherlands Institute of Mental Health and Addiction (The Netherlands)

Sponsor details

P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
info@trimbos.nl

Sponsor type

Hospital/treatment centre

Website

http://www.trimbos.nl/default37.html

Funders

Funder type

Research organisation

Funder name

Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22116977

Publication citations

  1. Results

    Vlasveld MC, van der Feltz-Cornelis CM, Adèr HJ, Anema JR, Hoedeman R, van Mechelen W, Beekman AT, Collaborative care for major depressive disorder in an occupational healthcare setting., Br J Psychiatry, 2012, 200, 6, 510-511, doi: 10.1192/bjp.bp.111.095687.

Additional files

Editorial Notes