Depressive Disorders Clinical Trial
Official title:
Evaluation of the Effectiveness and Efficiency of a Psychoeducational Group Sessions Intervention Program in the Depressive Episode Realized by Primary Health Care Center Nurses in Barcelona City.
The purpose of this study is to compare the effectiveness and efficiency of doing a psychoeducational group program and the conventional treatment versus individual conventional care in patients with a mild/moderate depression disorder,in urban primary healthcare centers in Barcelona city.
Nowadays, the depression is one of the public health major issues, this is because of its
prevalence and its economic and social repercussions. It is fundamental for the Primary Care
to assume the management of these health problems.
Design:A randomised controlled trial of two groups (intervention and control), longitudinal
and prospective.
Population of study: The subjects of the study are patients of 20 to 65 years old attended
in 8 urban primary healthcare centers of Barcelona city, identified by the general
practitioners and nurses with diagnosis of mild/moderate depression disorder according to
the BDI scale.
The intervention group receive weekly a psychoeducational group program during 12 weeks run
by 2 nurses. The program have a structured content where patient is educated about the
illness, pharmacological treatment, the adherence to treatment, diet and physical exercise,
problem solving, and cognitive-behavioral therapy.
In the control group the depression in treated as usual with the conventional care.
Measure's tool: The evolution of patients will be monitoring up to 1 year after the
inclusion by a individual interview (the first visit and 3,6 and 9 months).The Beck
Depression inventory (BDI) is a self-administered questionnaire that measure the
symptomatology and severity of the depression.
The analysis variables are: patient's quality of life (EuroQoL-5D scale) ,clinical variables
of the patient, pharmacological prescription, anxiolytics and antidepressants consumption ,
sociodemographic, number of visits to primary healthcare center, number of days of labour
lost and cost.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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