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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2019-12-31

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.

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Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Group psychoeducation

Intervention Type BEHAVIORAL

Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses

Control Group

Usual clinical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Group psychoeducation

Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No