Effectiveness of a multi-component programme for managing depression in primary care: a cluster randomized trial. The INDI project.
BACKGROUND
There are significant shortcomings in the management and clinical outcomes of depressed patients. The objective is to assess the effectiveness of a multi-component programme to improve the management of depression in primary care.


METHODS
This is a cluster-randomized controlled trial, conducted between June 2007 and June 2010. Twenty primary care centres were allocated to intervention group or usual care group. The intervention consisted of a multi-component programme with clinical, educational and organizational procedures including primary care nurses working as case-managers. Outcomes were monitored by a blinded interviewer at 0, 3, 6 and 12 months.


BACKGROUND
ISRCTN16384353, at http://isrctn.org.


RESULTS
In total, 338 adult patients with major depression (DSM-IV) were assessed at baseline. At 12 months, 302 patients were assessed, 172 in the intervention group and 130 in the control group. The severity of depression (mean Patient Health Questionnaire-9 score) was 1.76 points lower in the intervention group [7.15 vs. 8.78, 95% CI=-3.53 to 0.02, p=0.053]. The treatment response rate was 15.4% higher in the intervention group than in the controls [66.9% vs. 51.5%, odds ratio 1.9, 95% CI=1.2 to 3.1, p=0.011)], and the remission rate was 13.4% higher [48.8% vs. 35.4%, odds ratio 1.8, 95% CI=1.1 to 2.9, p=0.026)].


CONCLUSIONS
Unblinded physicians diagnosed depression in their patients and decided whether to include them in the study, so we cannot discount a hidden selection bias.


CONCLUSIONS
The programme for managing depression leads to better clinical outcomes in patients with major depression in primary care settings.
Tarragona-Reus Primary Care Area, Catalan Health Institute and IDIAP (Primary Care Research Institute) Jordi Gol, Barcelona, Spain. earagones.tarte.ics@gencat.cat
Enric
E
Aragonès
Josep Lluís
JL
Piñol
Antonia
A
Caballero
Germán
G
López-Cortacans
Pilar
P
Casaus
Josep Maria
JM
Hernández
Waleska
W
Badia
Sílvia
S
Folch
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D019090:Case Management / Q000458:organization & administration; D016000:Cluster Analysis; D003865:Major Depressive Disorder / Q000628:therapy*; D004363:Drug Utilization; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D010349:Patient Compliance; D010353:Patient Education as Topic / Q000458:organization & administration; D017060:Patient Satisfaction; D011320:Primary Health Care / Q000379:methods / Q000458:organization & administration*; D015397:Program Evaluation
D000928:Antidepressive Agents