Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity
- Conditions
- Depressive Disorder
- Registration Number
- NCT03243799
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 504
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in rate of remission of depression At 12 months of follow-up Changes in the score of the BDI-II scale
- Secondary Outcome Measures
Name Time Method Changes in rate of remission of depression At 3 months of follow-up Changes in the score of the BDI-II scale
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
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
Quantification of the use of services At 12 months of follow-up Number of hospital admissions
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 control of DM2 At 12 months of follow-up Changes in HbA1c
Record of therapeutic compliance At 12 months of follow-up Morisky-Green test
Referrals to mental health At 12 months of follow-up Number of visits to mental health centers
Changes in the quality of life At 12 months of follow-up Measured by the EuroQol scale (EQ-5D)
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
Changes in the control of COPD At 12 months of follow-up Changes in FEV1
Trial Locations
- Locations (1)
Centre d'Atenció Primària (CAP) Santa Margarida de Montbui
🇪🇸Santa Margarida de Montbui, Barcelona, Spain
Centre d'Atenció Primària (CAP) Santa Margarida de Montbui🇪🇸Santa Margarida de Montbui, Barcelona, Spain