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van CCT (UK)

van CCT (UK)

Collaborative Care: Depression Initative in the Medical Setting.

- candidate number2331
- NTR NumberNTR818
- Date ISRCTN created1-dec-2006
- date ISRCTN requested1-dec-2006
- Date Registered NTR21-nov-2006
- Secondary IDsN/A 
- Public TitleCollaborative Care: Depression Initative in the Medical Setting.
- Scientific TitleCost-effectiveness of collaborative care for chronic medically ill patients with comorbid depressive disorder in the general hospital setting.
- hypothesisThe collaborative care approach is expected to be more effective and more cost-effective compared to care as usual.
- Healt Condition(s) or Problem(s) studiedComorbid depressive disorder
- Inclusion criteriaAll 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 criteriaSuicidality (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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-dec-2006
- planned closingdate1-dec-2010
- Target number of participants126
- InterventionsA 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.
- Primary outcomeSeverity of depressive symptoms.
- Secondary outcomeThe cost-utility of collaborative care compared to CAU.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C.M. Feltz-Cornelis, van der
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
Onze Lieve Vrouwe Gasthuis (OLVG), Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ)
- PublicationsN/A
- Brief summaryIntroduction Depressive disorder is one of the two most common disorders and is even more prevalent in chronic medically ill patients. The presence of comorbid depression has a negative influence on quality of life, costs, morbidity, and mortality. Early diagnosis and well-organized treatment of depression has a positive influence on these aspects. However, recognition and treatment of depression remains unsatisfactory since the knowledge needed to perform the treatment is still unavailable in various settings. Prior research in the US has shown good results regarding the treatment of depression using a collaborative care approach and an antidepressant algorithm. In the UK ‘Problem Solving Treatment’ has proved to be feasible. In the general hospital setting, this approach has not yet been evaluated. Methods/design CC: DIM (Collaborative Care: Depression Initiative in the Medical setting) is a two armed randomized clinical trial with randomization between patients. Aim of the trial is to evaluate the treatment of depressive disorder in the general hospital in the Netherlands by means of a collaborative care framework including contracting, problem solving treatment, antidepressant algorithm, and manual guided self-help. 150 outpatients with diabetes, COPD, cardiovascular diseases, and HIV are randomised between intervention and control group. Patients are included who are diagnosed with moderate to severe depression based on DSM-IV criteria by a two-step screening method. The intervention group receives treatment based on the collaborative care approach; the control group receives ‘Care As Usual’. Baseline and follow-up measures (3, 6, 9, and 12 months) are done by means of questionnaires. Primary outcome measure is severity of depressive symptoms as measured with the PHQ-9. Secondary outcome measure is the cost-effectiveness of these treatments as measured by the TiC-P, EuroQol and the SF-36. Discussion Prior research has pointed out that depressive disorder is a chronic, mostly recurrent illness, which tends to cluster with physical comorbidity. Furthermore, even though the treatment of depressive disorder as described in the guidelines on depression are proven effective, they are often used insufficiently. Collaborative care and problem solving treatment will be specifically tailored to the medically ill with depressive disorders and evaluated in the Dutch general hospital setting.
- Main changes (audit trail)
- RECORD21-nov-2006 - 12-jan-2007

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