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Clinical Trials/NCT03243799
NCT03243799
Unknown
N/A

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country504 target enrollmentNovember 6, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Disorder
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
504
Locations
1
Primary Endpoint
Changes in rate of remission of depression
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2017
End Date
December 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in rate of remission of depression

Time Frame: At 12 months of follow-up

Changes in the score of the BDI-II scale

Secondary Outcomes

  • Quantification of the use of services(At 12 months of follow-up)
  • Changes in rate of remission of depression(At 3 months of follow-up)
  • Changes in the control of asthma(At 12 months of follow-up)
  • Changes in the control of Ischemic heart disease(At 12 months of follow-up)
  • Satisfaction with the intervention(At 3 months of follow-up)
  • Adherence to the intervention(At 3 months of follow-up)
  • Changes in the control of COPD(At 12 months of follow-up)
  • Qualitative changes of the state of health at the end of the intervention(At 3 and 12 months of follow-up)
  • Changes in the control of DM2(At 12 months of follow-up)
  • Record of therapeutic compliance(At 12 months of follow-up)
  • Referrals to mental health(At 12 months of follow-up)
  • Changes in the quality of life(At 12 months of follow-up)
  • Qualitative changes of the state of mind at the end of the intervention(At 3 and 12 months of follow-up)

Study Sites (1)

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