Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

Depressive Disorders Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00841737
• Other study ID #: PI07/90712
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2009
• Last updated: August 5, 2009
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2009
• Source: Jordi Gol i Gurina Foundation
• Contact: Rocio Casañas Sánchez, Psychologist
• Phone: 0034. 695560597
• Email: rocio.casanas[@]chmcorts.com; rcasanas[@]gencat.cat
• Is FDA regulated: No
• Health authority: Spain: Ministry of HealthSpain: Ethics CommitteeSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: April 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorders

Intervention

Other:
• Psychoeducational group
The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.
• Control Group
In the control group the depression is treated as usual with the conventional treatment.

Locations

Country	Name	City	State
Spain	Primary Health Care . Catalan Health Institute (ICS)	Barcelona
Spain	Primary health care. Catalan Health Institute (ICS)	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Centre de Higiene Mental Les Corts, Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No