Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

Sponsor
Jordi Gol i Gurina Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT00841737
Collaborator
Hospital Universitari Vall d'Hebron Research Institute (Other), Centre d'Higiene Mental Les Corts (Other)
192
2
2
27
96
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Psychoeducational group
  • Other: Control Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jul 1, 2009
Anticipated Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.
Other Names:
  • Psychoeducational group;
  • Depression group intervention.
  • Active Comparator: Control group

    Individual conventional care

    Other: Control Group
    In the control group the depression is treated as usual with the conventional treatment.
    Other Names:
  • conventional treatment group;
  • usual care group
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [First visit and 3, 6 and 9 months.]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Beck Depression Inventory(BDI)>10 and <30.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Primary Health Care . Catalan Health Institute (ICS) Barcelona Spain 08023
    2 Primary health care. Catalan Health Institute (ICS) Barcelona Spain 08023

    Sponsors and Collaborators

    • Jordi Gol i Gurina Foundation
    • Hospital Universitari Vall d'Hebron Research Institute
    • Centre d'Higiene Mental Les Corts

    Investigators

    • Principal Investigator: Rocio CasaƱas, Psychologist, Barcelona Primary Care Area. Catalan Health Institute (ICS)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00841737
    Other Study ID Numbers:
    • PI07/90712
    First Posted:
    Feb 11, 2009
    Last Update Posted:
    Aug 6, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 6, 2009