Depressive DisordersNCT00841737
Evaluation of a Psychoeducation Group Program for Mild/Moderate Depression
A study testing Psychoeducational group in people with Depressive Disorders, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depressive Disorders
- What is being tested?
- Psychoeducational group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Beck Depression Inventory(BDI)>10 and <30.
- Diagnosis of mild/moderate depressive disorders.
- Signed the Informed Consent.
Who cannot join
- 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,
Show all 10Show fewer
- sensory or cognitive disabilities,
- illiteracy,
- does not know or not give consent to participate in the study,
- temporary residents.
Trial locations and contacts
2 sites in 1 country.
Rocio Casañas Sánchez, Psychologist contact
Spain2 sites, 2 recruiting
- Recruiting
Primary Health Care . Catalan Health Institute (ICS)
Barcelona, Barcelona, 08023
Rocio Casañas, Psychologist, 0034.695.56.05.97, rocio.casanas@chmcorts.com; rcasanas@gencat.cat
Rocio Casañas
- Recruiting
Primary health care. Catalan Health Institute (ICS)
Barcelona, Barcelona, 08023
Rocio Casañas, Psychologist, 0034.695.56.05.97, rocio.casanas@chmcorts.com; rcasanas@gencat.cat
Antonia Raya, Nurse
About this study
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.
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.
- Conditions
- Depressive Disorders
- Being tested
- Psychoeducational group, Control Group
- Keywords
- Depressive Disorders;, Primary Health Care;, Nurses;, Health education.
- Medical subject headings
- Depressive Disorder, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational groupOther
Also called Psychoeducational group;, Depression group intervention.
The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend.
Control GroupOther
Also called conventional treatment group;, usual care group
In the control group the depression is treated as usual with the conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational group intervention | Experimental | Psychoeducational group received weekly a psychoeducational intervention during a period of 12 weeks run by a nurses. Receives: Other: Psychoeducational group |
| Control group | Active comparator | Individual conventional care Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First visit and 3,6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute, Centre d'Higiene Mental Les Corts
- Investigators
- Rocio Casañas, Psychologist, Principal investigator, Barcelona Primary Care Area. Catalan Health Institute (ICS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841737
- Sponsor's protocol ID
- PI07/90712
- Status last verified
- Aug 2009
- First submitted
- 3 Feb 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00841737
- Acronym / sponsor ID
- PI07/90712
- Conditions
- Depressive Disorders
- Keywords
- Depressive Disorders;, Primary Health Care;, Nurses;, Health education.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute, Centre d'Higiene Mental Les Corts
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2010 (estimated)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational group intervention | Experimental | Other: Psychoeducational groupPsychoeducational group received weekly a psychoeducational intervention during a period of 12 weeks run by a nurses. |
| Control group | Active comparator | Other: Control GroupIndividual conventional care |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Beck Depression Inventory(BDI)>10 and <30.
- Diagnosis of mild/moderate depressive disorders.
- Signed the Informed Consent.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational groupAlso: Psychoeducational group;, Depression group intervention.The intervention group receive weekly a psychoeducational group during 12 weeks run by 2 nurses. The program have a structures contend. | Other | Psychoeducational group intervention |
| Control GroupAlso: conventional treatment group;, usual care groupIn the control group the depression is treated as usual with the conventional treatment. | Other | Control group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Derived from this study: PubMed 23249399Casanas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocio Casañas Sánchez, Psychologist contact
Rocio Casañas, Psychologist principal investigator
Barcelona Primary Care Area. Catalan Health Institute (ICS)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational group in people with Depressive Disorders, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocio Casañas Sánchez, Psychologist (0034. 695560597, rocio.casanas@chmcorts.com; rcasanas@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.