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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR818 |
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Date of registration:
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21/11/2006 |
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Primary sponsor: |
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Public title:
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Collaborative Care: Depression Initative in the Medical Setting.
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Scientific title:
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Cost-effectiveness of collaborative care for chronic medically ill patients with comorbid depressive disorder in the general hospital setting. - CC: DIM |
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Date of first enrolment:
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1/12/2006 |
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Target sample size:
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126 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=818 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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C.M.
Feltz-Cornelis, van der |
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Address:
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Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Department of Diagnosis en Treatment,
P.O. Box 725, Da Costakade 45
3500 AS
Utrecht
The Netherlands |
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Telephone:
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Email:
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cfeltz@trimbos.nl |
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Affiliation:
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Name:
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Eva
Horn |
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Address:
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Trimbos-instituut / Netherlands institute of Mental Health and Addiction,
Da Costakade 45,
P.O. Box 725
3500 AS
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2959303 |
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Email:
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ehorn@trimbos.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients of the Onze Lieve Vrouwe Gasthuis visiting the participating outpatient clinics (diabetes, cardiology, HIV, and part of lung medicine [patients with COPD]) and who already have a diagnosis specified in their file. Patients are included in the study if a cut off score of 15 (moderate to severe depressive disorder) is reached on a the PHQ-9, which measures depression severity. The symptoms have to be present for at least six weeks or have to cause marked dysfunctioning (e.g. problems at work, housekeeping).
Exclusion criteria: Suicidality (in case of a high risk for suicide, patients will be referred.)
(Concerning the following criteria a suggestion is given to the patients concerning a different kind of help:)
-Psychotic
-Suffering from dementia or delirium
-Insufficient knowledge of the Dutch language to fill in questionnaires
-Serious mental impairment
-Alcohol or drug addiction
-Already receiving psychiatric treatment
-Pregnancy
-Bipolar disorder
Concerning HIV patients:
-Organic psychosyndrome
-Personality change
-In terminal phase
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Comorbid depressive disorder
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Intervention(s)
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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.
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Primary Outcome(s)
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Severity of depressive symptoms.
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Secondary Outcome(s)
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The cost-utility of collaborative care compared to CAU.
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Secondary ID(s)
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ISRCTN95575369
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N/A
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Source(s) of Monetary Support
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Onze Lieve Vrouwe Gasthuis (OLVG), Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ)
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