Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression
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.
1 other identifier
interventional
192
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 6, 2009
August 1, 2009
1.5 years
February 3, 2009
August 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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
Study Arms (2)
Psychoeducational group intervention
EXPERIMENTALPsychoeducational group received weekly a psychoeducational intervention during a period of 12 weeks run by a nurses.
Control group
ACTIVE COMPARATORIndividual conventional care
Interventions
The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.
In the control group the depression is treated as usual with the conventional treatment.
Eligibility Criteria
You may qualify if:
- Beck Depression Inventory(BDI)\>10 and \<30.
- Diagnosis of mild/moderate depressive disorders.
- Signed the Informed Consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Primary Health Care . Catalan Health Institute (ICS)
Barcelona, Barcelona, 08023, Spain
Primary health care. Catalan Health Institute (ICS)
Barcelona, Barcelona, 08023, Spain
Related Publications (1)
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.
PMID: 23249399DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rocio Casañas, Psychologist
Barcelona Primary Care Area. Catalan Health Institute (ICS)
Central Study Contacts
Rocio Casañas Sánchez, Psychologist
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 11, 2009
Study Start
January 1, 2008
Primary Completion
July 1, 2009
Study Completion
April 1, 2010
Last Updated
August 6, 2009
Record last verified: 2009-08