No registrations found.
ID
Source
Brief title
Health condition
The collaborative care approach is compared with well documented Care as Usual (CAU) as provided by General Practitioners (GPs).
Sponsors and support
PO Box 725
3500 AS Utrecht
The Netherlands
Intervention
Outcome measures
Primary outcome
The primary outcome measure is response. Secondary outcome measures are remission as measured by the PHQ9 and IDS-SR, effect of chronic physical illness as an effect modifier, and cost-effectiveness as measured with the TiC-P, EQ-5D and the SF-36.
Secondary outcome
Secondary outcome measures are remission, effect of chronic physical illness and cost-effectiveness.
Background summary
Background:
Depressive disorder is today one of the two most burdensome disorders. Evidence-based treatments of depressive disorder are already available, but are used insufficiently and with less results than possible. Prior research in the USA has shown good results in the treatment of depressive disorder by using a collaborative care approach with Problem Solving Treatment (PST) and an antidepressant treatment algorithm, and prior research in the UK has also shown good results with PST. These treatment strategies may very well work in the Netherlands too, even though health care systems differ between countries.
Methods/design:
The present study is a two armed cluster-randomized clinical trial, with randomization between general practitioner (GP) practices. The aim of the trial is an evaluation of the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework including contracting and adherence improving strategies, and combined with the option of PST and/or an antidepressant medication following a treatment algorithm. Forty GP practices will be randomised between the intervention group or control group. Patients are included who are diagnosed with moderate to severe depression based on DSM-IV criteria. The intervention group receives treatment based on the collaborative care approach, the control group receives care as usual (CAU). Baseline measures and follow up measures (3, 6 and 12 months) are assessed using questionnaires and interview. The primary outcome measure is response as measured by the PHQ9 and IDS-SR. Secondary outcome measures are remission as measured by the PHQ9 and IDS-SR, effect of chronic physical illness as key effect modifier, and cost-effectiveness as measured with the TiC-P, EQ-5D and the SF-36.
Discussion:
In the current study, an American model to enhance care for depressive patients, the collaborative care model, will be evaluated for effectiveness in the primary care setting. If effective across the Atlantic and across different health care systems, it is likely to be a good strategy to implement in the treatment of major depressive disorder in the Netherlands.
Study objective
The aim of the current randomized clinical trial (RCT) is a cost-effectiveness analyses of a collaborative care approach compared to Care as Usual (CAU). The collaborative care approach is expected to be more effective and cost-effective than CAU.
Intervention
The collaborative care approach includes care management, contracting, adherence improving strategies, manual guided self help and lifestyle interventions, Problem Solving Treatment, and an antidepressant treatment algorithm; the treatment plan is set based on patient preferences.
Da Costakade 45,
P.O. Box 725
F.J. Jong de
Utrecht 3500 AS
The Netherlands
+31 (0)30 2971185
mijff@trimbos.nl
Da Costakade 45,
P.O. Box 725
F.J. Jong de
Utrecht 3500 AS
The Netherlands
+31 (0)30 2971185
mijff@trimbos.nl
Inclusion criteria
The aim is to include patients who are diagnosed with major depressive disorder and who dysfunction due to the depressive disorder (i.e. loss of role in daily life).
Exclusion criteria
Patients are excluded from the study if they are suicidal, psychotic or suffering from dementia, have insufficient knowledge of Dutch to fill in the questionnaires, are addicted to drugs or alcohol, already receive psychiatric treatment and/or are less than 18 years old.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL807 |
| NTR-old | NTR820 |
| Other | : N/A |
| ISRCTN | ISRCTN15266438 |
Summary results
Beekman, Leona Hakkaart-Van Rooijen, Frans F Rutten, Jurgen Unutzer,
Christina M van der Feltz-Cornelis. Cost-effectiveness of collaborative
care including PST and an antidepressant treatment algorithm for the
treatment of major depressive disorder in primary care; a randomised
clinical trial BMC Health Services Research 2007;7:34