CClinicalTrials.gg
Status unknownNCT00841737Updated Aug 6, 2009

Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression

An interventional study of Psychoeducational group and Control Group in Depressive Disorders, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 2 sites in Spain. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-08-06.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depressive Disorders

Keywords

  • Depressive Disorders;
  • Primary Health Care;
  • Nurses;
  • Health education.
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 192 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Beck Depression Inventory(BDI)>10 and \<30.
  • Diagnosis of mild/moderate depressive disorders.
  • Signed the Informed Consent.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    Psychoeducational group intervention

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

    Other: Psychoeducational group

  • Active comparator
    Control group

    Individual conventional care

    Other: Control Group

Interventions

  • OtherPsychoeducational group

    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.

  • OtherControl Group

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

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

06

What researchers measure

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.

    Time frame: 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.

    Time frame: First visit and 3,6 and 9 months

07

Study locations

2 of 2 sites recruiting
  • Primary Health Care . Catalan Health Institute (ICS)
    Barcelona, 08023, Spain
    Recruiting
  • Primary health care. Catalan Health Institute (ICS)
    Barcelona, 08023, Spain
    • Rocio Casañas, Psychologist · Contact · rocio.casanas@chmcorts.com; rcasanas@gencat.cat · 0034.695.56.05.97
    • Antonia Raya, Nurse · Sub investigator
    • Inés Falder, Nurse · Sub investigator
    • Maria Antonia Campo, Nurse · Sub investigator
    • Eva Maria Fernandez, Nurse · Sub investigator
    • Elena Puigdevall, Psychologist · Sub investigator
    • Jordi Armengol, Psychologist · Sub investigator
    • Amparo Escudero, Nurse · Sub investigator
    • Teresa Romero, Nurse · Sub investigator
    • Jose Luis del Val, MD · Sub investigator
    • Sergi Valero, Psychologist · Sub investigator
    • Miquel Casas, MD, PhD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23249399 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00841737
Lead 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
First posted
Feb 11, 2009
Start date
Jan 2008
Primary completion
Jul 2009
Completion
Apr 2010 (estimated)
Last update
Aug 6, 2009

Study contacts

Rocio Casañas Sánchez, Psychologist
Contact
rocio.casanas@chmcorts.com; rcasanas@gencat.cat
0034. 695560597
Rocio Casañas, Psychologist
principal investigator · Barcelona Primary Care Area. Catalan Health Institute (ICS)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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