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Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

Primary Purpose

Depressive Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychoeducational group
Control Group
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorders focused on measuring Depressive Disorders;, Primary Health Care;, Nurses;, Health education.

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Primary Health Care . Catalan Health Institute (ICS)Recruiting
  • Primary health care. Catalan Health Institute (ICS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychoeducational group intervention

Control group

Arm Description

Psychoeducational group received weekly a psychoeducational intervention during a period of 12 weeks run by a nurses.

Individual conventional care

Outcomes

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.

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.

Full Information

First Posted
February 3, 2009
Last Updated
August 5, 2009
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
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1. Study Identification

Unique Protocol Identification Number
NCT00841737
Brief Title
Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorders
Keywords
Depressive Disorders;, Primary Health Care;, Nurses;, Health education.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducational group intervention
Arm Type
Experimental
Arm Description
Psychoeducational group received weekly a psychoeducational intervention during a period of 12 weeks run by a nurses.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Individual conventional care
Intervention Type
Other
Intervention Name(s)
Psychoeducational group
Other Intervention Name(s)
Psychoeducational group;, Depression group intervention.
Intervention Description
The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
conventional treatment group;, usual care group
Intervention Description
In the control group the depression is treated as usual with the conventional treatment.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rocio Casañas Sánchez, Psychologist
Phone
0034. 695560597
Email
rocio.casanas@chmcorts.com; rcasanas@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocio Casañas, Psychologist
Organizational Affiliation
Barcelona Primary Care Area. Catalan Health Institute (ICS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Care . Catalan Health Institute (ICS)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Casañas, Psychologist
Phone
0034.695.56.05.97
Email
rocio.casanas@chmcorts.com; rcasanas@gencat.cat
First Name & Middle Initial & Last Name & Degree
Rocio Casañas
Facility Name
Primary health care. Catalan Health Institute (ICS)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Casañas, Psychologist
Phone
0034.695.56.05.97
Email
rocio.casanas@chmcorts.com; rcasanas@gencat.cat
First Name & Middle Initial & Last Name & Degree
Antonia Raya, Nurse
First Name & Middle Initial & Last Name & Degree
Inés Falder, Nurse
First Name & Middle Initial & Last Name & Degree
Maria Antonia Campo, Nurse
First Name & Middle Initial & Last Name & Degree
Eva Maria Fernandez, Nurse
First Name & Middle Initial & Last Name & Degree
Elena Puigdevall, Psychologist
First Name & Middle Initial & Last Name & Degree
Jordi Armengol, Psychologist
First Name & Middle Initial & Last Name & Degree
Amparo Escudero, Nurse
First Name & Middle Initial & Last Name & Degree
Teresa Romero, Nurse
First Name & Middle Initial & Last Name & Degree
Jose Luis del Val, MD
First Name & Middle Initial & Last Name & Degree
Sergi Valero, Psychologist
First Name & Middle Initial & Last Name & Degree
Miquel Casas, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23249399
Citation
Casanas R, Catalan R, del Val JL, Real J, Valero S, Casas M. Effectiveness of a psycho-educational group program for major depression in primary care: a randomized controlled trial. BMC Psychiatry. 2012 Dec 18;12:230. doi: 10.1186/1471-244X-12-230.
Results Reference
derived

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Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

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