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Clinical Trials/NCT00841737
NCT00841737
Unknown
N/A

Evaluation of the Effectiveness and Efficiency of a Psychoeducational Group Sessions Intervention Program in the Depressive Episode Realized by Primary Health Care Center Nurses in Barcelona City.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 sites in 1 country192 target enrollmentJanuary 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Disorders
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
192
Locations
2
Primary Endpoint
To measure the symptomatology of the depression by Beck Depression Inventory (BDI) It's a self-administered questionnaire with 21 items (multiple-choice)to measure the intensity, severity and depth of depression.
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to compare the effectiveness and efficiency of doing a psychoeducational group program and the conventional treatment versus individual conventional care in patients with a mild/moderate depression disorder,in urban primary healthcare centers in Barcelona city.

Detailed Description

Nowadays, the depression is one of the public health major issues, this is because of its prevalence and its economic and social repercussions. It is fundamental for the Primary Care to assume the management of these health problems. Design:A randomised controlled trial of two groups (intervention and control), longitudinal and prospective. Population of study: The subjects of the study are patients of 20 to 65 years old attended in 8 urban primary healthcare centers of Barcelona city, identified by the general practitioners and nurses with diagnosis of mild/moderate depression disorder according to the BDI scale. The intervention group receive weekly a psychoeducational group program during 12 weeks run by 2 nurses. The program have a structured content where patient is educated about the illness, pharmacological treatment, the adherence to treatment, diet and physical exercise, problem solving, and cognitive-behavioral therapy. In the control group the depression in treated as usual with the conventional care. Measure's tool: The evolution of patients will be monitoring up to 1 year after the inclusion by a individual interview (the first visit and 3,6 and 9 months).The Beck Depression inventory (BDI) is a self-administered questionnaire that measure the symptomatology and severity of the depression. The analysis variables are: patient's quality of life (EuroQoL-5D scale) ,clinical variables of the patient, pharmacological prescription, anxiolytics and antidepressants consumption , sociodemographic, number of visits to primary healthcare center, number of days of labour lost and cost.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
April 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • Beck Depression Inventory(BDI)\>10 and \<
  • Diagnosis of mild/moderate depressive disorders.
  • Signed the Informed Consent.

Exclusion Criteria

  • Patients diagnosed of severe mental psychiatric disorder,
  • Patients diagnosed of a major depressive disorders,
  • Patients with acute illness or near-terminal medical illness,
  • using secondary mental health services,
  • suicidal ideation or intentions,
  • don't speak and understand spanish or/and catalan language,
  • sensory or cognitive disabilities,
  • illiteracy,
  • does not know or not give consent to participate in the study,
  • temporary residents.

Outcomes

Primary Outcomes

To measure the symptomatology of the depression by Beck Depression Inventory (BDI) It's a self-administered questionnaire with 21 items (multiple-choice)to measure the intensity, severity and depth of depression.

Time Frame: First visit and 3, 6 and 9 months.

Secondary Outcomes

  • To measure the patient's quality of life by the EuroQoL questionnaire; number of visits to primary health care center( doctor and nurse); number of days of labour lost; pharmacological prescription; antidepressant and anxiolytics consumption.(First visit and 3,6 and 9 months)

Study Sites (2)

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