Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- 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. ] [ Designated as safety issue: No ]
- 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. [ Time Frame: First visit and 3,6 and 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||April 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Psychoeducational group intervention
Psychoeducational group received weekly a psychoeducational intervention during a period of 12 weeks run by a nurses.
Other: Psychoeducational group
The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.
Active Comparator: Control group
Individual conventional care
Other: Control Group
In the control group the depression is treated as usual with the conventional treatment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841737
|Primary Health Care . Catalan Health Institute (ICS)|
|Barcelona, Spain, 08023|
|Primary health care. Catalan Health Institute (ICS)|
|Barcelona, Spain, 08023|
|Principal Investigator:||Rocio Casañas, Psychologist||Barcelona Primary Care Area. Catalan Health Institute (ICS)|