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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
504
Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses
Centre d'Atenció Primària (CAP) Santa Margarida de Montbui
Santa Margarida de Montbui, Barcelona, Spain
Changes in rate of remission of depression
Changes in the score of the BDI-II scale
Time frame: At 12 months of follow-up
Changes in rate of remission of depression
Changes in the score of the BDI-II scale
Time frame: At 3 months of follow-up
Changes in the control of DM2
Changes in HbA1c
Time frame: At 12 months of follow-up
Changes in the control of COPD
Changes in FEV1
Time frame: At 12 months of follow-up
Changes in the control of asthma
Changes in FEV1
Time frame: At 12 months of follow-up
Changes in the control of Ischemic heart disease
Changes in LDL cholesterol
Time frame: At 12 months of follow-up
Referrals to mental health
Number of visits to mental health centers
Time frame: At 12 months of follow-up
Record of therapeutic compliance
Morisky-Green test
Time frame: At 12 months of follow-up
Changes in the quality of life
Measured by the EuroQol scale (EQ-5D)
Time frame: At 12 months of follow-up
Quantification of the use of services
Number of hospital admissions
Time frame: At 12 months of follow-up
Satisfaction with the intervention
Survey at the end of the intervention
Time frame: At 3 months of follow-up
Adherence to the intervention
Number of assisted sessions
Time frame: At 3 months of follow-up
Qualitative changes of the state of mind at the end of the intervention
better, equal or worse
Time frame: At 3 and 12 months of follow-up
Qualitative changes of the state of health at the end of the intervention
better, equal or worse
Time frame: At 3 and 12 months of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.