Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Universitari Vall d'Hebron Research Institute
Centre de Higiene Mental Les Corts
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00841737
First received: February 3, 2009
Last updated: August 5, 2009
Last verified: August 2009
  Purpose

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 Intervention
Depressive Disorders
Other: Psychoeducational group
Other: Control Group

Study Type: Interventional
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.

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 192
Study Start Date: January 2008
Estimated Study Completion Date: April 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841737

Contacts
Contact: Rocio Casañas Sánchez, Psychologist 0034. 695560597 rocio.casanas@chmcorts.com; rcasanas@gencat.cat

Locations
Spain
Primary Health Care . Catalan Health Institute (ICS) Recruiting
Barcelona, Spain, 08023
Contact: Rocio Casañas, Psychologist    0034.695.56.05.97    rocio.casanas@chmcorts.com; rcasanas@gencat.cat   
Principal Investigator: Rocio Casañas         
Primary health care. Catalan Health Institute (ICS) Recruiting
Barcelona, Spain, 08023
Contact: Rocio Casañas, Psychologist    0034.695.56.05.97    rocio.casanas@chmcorts.com; rcasanas@gencat.cat   
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         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Hospital Universitari Vall d'Hebron Research Institute
Centre de Higiene Mental Les Corts
Investigators
Principal Investigator: Rocio Casañas, Psychologist Barcelona Primary Care Area. Catalan Health Institute (ICS)
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rocio Casañas, Barcelona Primary Care Area . Catalan Health Institute (Institut Catala de la Salut (ICS)).
ClinicalTrials.gov Identifier: NCT00841737     History of Changes
Other Study ID Numbers: PI07/90712
Study First Received: February 3, 2009
Last Updated: August 5, 2009
Health Authority: Spain: Ministry of Health
Spain: Ethics Committee
Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Depressive Disorders;
Primary Health Care;
Nurses;
Health education.

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 30, 2014