Depressive Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALGroup psychoeducation
Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses
Sponsors
Carlos III Health Institute
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of at least one of the following diseases: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. * Meet major depression criteria at the time of the study: Score above 13 on the BDI-II scale. * Possibility of follow-up of one year by the same primary care team. * At least read and write Spanish or Catalan.
Exclusion criteria
* Diagnosis of dementia or moderate or high cognitive impairment (5 or more errors according to the pfeiffer scale). * Major depression with psychotic symptoms or with other serious psychiatric comorbidities. * Moderate or high risk of suicide (6 or more points on the MINI suicide scale). * Dependency disorders due to alcohol or other drug abuse. * Advanced stage physical disease. * Inability to travel to the center. * Be receiving some psychological therapy by the Center of mental health (CSM) of reference
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in rate of remission of depression | At 12 months of follow-up | Changes in the score of the BDI-II scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the control of DM2 | At 12 months of follow-up | Changes in HbA1c |
| Changes in the control of COPD | At 12 months of follow-up | Changes in FEV1 |
| Changes in the control of asthma | At 12 months of follow-up | Changes in FEV1 |
| Changes in the control of Ischemic heart disease | At 12 months of follow-up | Changes in LDL cholesterol |
| Referrals to mental health | At 12 months of follow-up | Number of visits to mental health centers |
| Record of therapeutic compliance | At 12 months of follow-up | Morisky-Green test |
| Changes in rate of remission of depression | At 3 months of follow-up | Changes in the score of the BDI-II scale |
| Quantification of the use of services | At 12 months of follow-up | Number of hospital admissions |
| Satisfaction with the intervention | At 3 months of follow-up | Survey at the end of the intervention |
| Adherence to the intervention | At 3 months of follow-up | Number of assisted sessions |
| Qualitative changes of the state of mind at the end of the intervention | At 3 and 12 months of follow-up | better, equal or worse |
| Qualitative changes of the state of health at the end of the intervention | At 3 and 12 months of follow-up | better, equal or worse |
| Changes in the quality of life | At 12 months of follow-up | Measured by the EuroQol scale (EQ-5D) |
Countries
Spain
Outcome results
None listed