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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Depressive Disorder

Treatments: Behavioral: Group psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03243799

PI16/01272

Details and patient eligibility

About

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.

Enrollment: 504 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

504 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Group psychoeducation

Control Group

No Intervention group

Description:

Usual clinical care