Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

August 5, 2009 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08023
      • Barcelona, Spain, 08023
        • Recruiting
        • Primary health care. Catalan Health Institute (ICS)
        • Contact:
        • Sub-Investigator:
          • Antonia Raya, Nurse
        • Sub-Investigator:
          • Inés Falder, Nurse
        • Sub-Investigator:
          • Maria Antonia Campo, Nurse
        • Sub-Investigator:
          • Eva Maria Fernandez, Nurse
        • Sub-Investigator:
          • Elena Puigdevall, Psychologist
        • Sub-Investigator:
          • Jordi Armengol, Psychologist
        • Sub-Investigator:
          • Amparo Escudero, Nurse
        • Sub-Investigator:
          • Teresa Romero, Nurse
        • Sub-Investigator:
          • Jose Luis del Val, MD
        • Sub-Investigator:
          • Sergi Valero, Psychologist
        • Sub-Investigator:
          • Miquel Casas, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
First visit and 3, 6 and 9 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
First visit and 3,6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Hospital Universitari Vall d'Hebron Research Institute
Centre d'Higiene Mental Les Corts

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 5, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI07/90712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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