Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

NCT ID: NCT00841737

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Depressive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psychoeducational group intervention

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

Group Type EXPERIMENTAL

Psychoeducational group

Intervention Type OTHER

The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.

Control group

Individual conventional care

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

In the control group the depression is treated as usual with the conventional treatment.

Interventions

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Psychoeducational group

The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.

Intervention Type OTHER

Control Group

In the control group the depression is treated as usual with the conventional treatment.

Intervention Type OTHER

Other Intervention Names

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Psychoeducational group; Depression group intervention. conventional treatment group; usual care group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role collaborator

Centre d'Higiene Mental Les Corts

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Barcelona Primary Care Area . Catalan Health Institute (Institut Catala de la Salut (ICS)).

Principal Investigators

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Rocio Casañas, Psychologist

Role: PRINCIPAL_INVESTIGATOR

Barcelona Primary Care Area. Catalan Health Institute (ICS)

Locations

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Primary Health Care . Catalan Health Institute (ICS)

Barcelona, Barcelona, Spain

Site Status RECRUITING

Primary health care. Catalan Health Institute (ICS)

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rocio Casañas Sánchez, Psychologist

Role: CONTACT

Facility Contacts

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Rocio Casañas, Psychologist

Role: primary

Rocio Casañas, Psychologist

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23249399 (View on PubMed)

Other Identifiers

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PI07/90712

Identifier Type: -

Identifier Source: org_study_id

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