Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity

Conditions
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Depressive Disorder

Intervention / Treatment
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* Behavioral: Group psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Behavioral: Group psychoeducation<br>* Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses<br>|
| No Intervention: Control Group<br>Usual clinical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |