Depressive Disorder Clinical Trial
Official title:
Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity
The primary aim is to evaluate the effectiveness of an intervention based on a
psychoeducational program carried out by primary care nurses, to improve the rate of
remission and response of depression in patients with physical chronic illness (diabetes,
COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness
of the intervention, the effectiveness to improve the control of physical pathology, the
impact on quality of life and the feasibility of the intervention.
Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up
evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over
50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural)
with major depression and with at least one of the diseases: diabetes mellitus type 2,
chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be
distributed randomly into two groups. The intervention group will participate in
psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting
of health education on chronic physical illness and depressive symptoms.
Main measurements: clinical remission of depression and / or response to intervention (Beck
depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease
(blood test and physical parameters), drug compliance (test Morinsky-Green and number of
packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital
admissions due to complications) and feasibility of the intervention (satisfaction and
compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months,
patients will receive a call from nurses.
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