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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from Primary Care, consisting of health education on chronic physical illness and depressive symptoms. Group psychoeducation. |
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| Control Group | No Intervention | Usual clinical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group psychoeducation | Behavioral | Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in rate of remission of depression | Changes in the score of the BDI-II scale | At 12 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in rate of remission of depression | Changes in the score of the BDI-II scale | At 3 months of follow-up |
| Changes in the control of DM2 | Changes in HbA1c |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Atenció Primà ria (CAP) Santa Margarida de Montbui | Santa Margarida de Montbui | Barcelona | 08710 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31242892 | Derived | Casanas R, Martin Royo J, Fernandez-San-Martin MI, Raya Tena A, Mendioroz J, Sauch Valmana G, Masa-Font R, Casajuana-Closas M, Fernandez Linares EM, Cols-Sagarra C, Gonzalez Tejon S, Foguet-Boreu Q, Martin Lopez LM. Effectiveness of a psychoeducation group intervention conducted by primary healthcare nurses in patients with depression and physical comorbidity: study protocol for a randomized, controlled trial. BMC Health Serv Res. 2019 Jun 26;19(1):427. doi: 10.1186/s12913-019-4198-7. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| At 12 months of follow-up |
| Changes in the control of COPD | Changes in FEV1 | At 12 months of follow-up |
| Changes in the control of asthma | Changes in FEV1 | At 12 months of follow-up |
| Changes in the control of Ischemic heart disease | Changes in LDL cholesterol | At 12 months of follow-up |
| Referrals to mental health | Number of visits to mental health centers | At 12 months of follow-up |
| Record of therapeutic compliance | Morisky-Green test | At 12 months of follow-up |
| Changes in the quality of life | Measured by the EuroQol scale (EQ-5D) | At 12 months of follow-up |
| Quantification of the use of services | Number of hospital admissions | At 12 months of follow-up |
| Satisfaction with the intervention | Survey at the end of the intervention | At 3 months of follow-up |
| Adherence to the intervention | Number of assisted sessions | At 3 months of follow-up |
| Qualitative changes of the state of mind at the end of the intervention | better, equal or worse | 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 | At 3 and 12 months of follow-up |