Condition category
Mental and Behavioural Disorders
Date applied
01/12/2006
Date assigned
01/12/2006
Last edited
05/03/2007
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 Eva Horn

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
ehorn@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CC:DIM

Study hypothesis

The collaborative care approach is expected to be more effective and more cost-effective compared to care as usual.

Ethics approval

The local ethics board of the 'Onze Lieve Vrouwe Gasthuis' (Amsterdam, the Netherlands) is in charge of approval of this study, and ethics approval was approved on the 21st December 2006.

Study design

Randomised controlled parallel armed trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic medically ill, Comorbid depressive disorder

Intervention

A treatment of depression fit in the collaborative care model with problem solving treatment, an antidepressant algorithm, contracting, care management, and a manual guided self-help depression for chronically ill patients.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Severity of depressive symptoms.

Secondary outcome measures

The cost-utility of collaborative care compared to CAU.

Overall trial start date

01/12/2006

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients of the Onze Lieve Vrouwe Gasthuis (OLVG) visiting the participating outpatient clinics:
a. diabetes
b. cardiology
c. Human Immumodeficiency Virus (HIV)
d. part of lung medicine (patients with Chronic Obstructive Pulmonary Disease [COPD])
and who already have a diagnosis specified in their file
2. Patients are included in the study if a cut off score of 15 (moderate to severe depressive disorder) is reached on a the Patient Health Questionnaire (PHQ-9), which measures depression severity
3. The symptoms have to be present for at least six weeks or have to cause marked dysfunctioning (e.g. problems at work, housekeeping)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

126

Participant exclusion criteria

1. Suicidality (in case of a high risk for suicide, patients will be referred)
2. Concerning the following criteria a suggestion is given to the patients concerned a different kind of help:
a. psychotic
b. suffering from dementia or delirium
c. insufficient knowledge of the Dutch language to fill in questionnaires
d. serious mental impairment
e. alcohol or drug addiction
f. already receiving psychiatric treatment
g. pregnancy
h. bipolar disorder
3. Concerning HIV patients:
a. organic psychosyndrome
b. personality change
c. in terminal phase

Recruitment start date

01/12/2006

Recruitment end date

01/12/2010

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

Funder name

Onze Lieve Vrouwe Gasthuis (OLVG) (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

Protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17324283

Publication citations

  1. Protocol

    Horn EK, van Benthem TB, Hakkaart-van Roijen L, van Marwijk HW, Beekman AT, Rutten FF, van der Feltz-Cornelis CM, Cost-effectiveness of collaborative care for chronically ill patients with comorbid depressive disorder in the general hospital setting, a randomised controlled trial., BMC Health Serv Res, 2007, 7, 28, doi: 10.1186/1472-6963-7-28.

Additional files

Editorial Notes