NCT00841737

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1.5 years

First QC Date

February 3, 2009

Last Update Submit

August 5, 2009

Conditions

Keywords

Depressive Disorders;Primary Health Care;Nurses;Health education.

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

EXPERIMENTAL

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

Other: Psychoeducational group

Control group

ACTIVE COMPARATOR

Individual conventional care

Other: Control Group

Interventions

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

Also known as: Psychoeducational group;, Depression group intervention.
Psychoeducational group intervention

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

Also known as: conventional treatment group;, usual care group
Control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Primary health care. Catalan Health Institute (ICS)

Barcelona, Barcelona, 08023, Spain

RECRUITING

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.

MeSH Terms

Conditions

Depressive DisorderHealth Education

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Rocio Casañas, Psychologist

    Barcelona Primary Care Area. Catalan Health Institute (ICS)

    PRINCIPAL INVESTIGATOR

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

Locations