- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01151982
Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial (predictD-CCRT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Málaga, Spain
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Málaga, Spain, 29009
- Servicio Andaluz de Salud. Distrito Sanitario Málaga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients among those attending to primary care centers.
Exclusion Criteria:
- Age under 18 or over 75 years.
- Unable to understand or speak Spanish.
- Represented patients (that is, someone else comes to visit on behalf of the patient).
- Cognitive impairment.
- Psychosis.
- Terminal illness.
- Planning to be outside of the the city during 4 or more months during the next 18 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psychosocial Intervention
The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient. We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group. The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors. The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources. |
The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient. We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group. The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors. The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources. |
No Intervention: Usual Care
The kind of care that general practitioners usually provide when not knowing the level and risk profile of depression of the patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accumulated incidence of major depression
Time Frame: 18 months
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18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness and cost-utility
Time Frame: 18 months
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To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.
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18 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Fernandez A, Mendive JM, Conejo-Ceron S, Moreno-Peral P, King M, Nazareth I, Martin-Perez C, Fernandez-Alonso C, Rodriguez-Bayon A, Aiarzaguena JM, Monton-Franco C, Serrano-Blanco A, Ibanez-Casas I, Rodriguez-Sanchez E, Salvador-Carulla L, Garay PB, Ballesta-Rodriguez MI, LaFuente P, Del Mar Munoz-Garcia M, Minguez-Gonzalo P, Araujo L, Palao D, Gomez MC, Zubiaga F, Navas-Campana D, Aranda-Regules JM, Rodriguez-Morejon A, de Dios Luna J, Bellon JA. A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial. BMC Med. 2018 Feb 23;16(1):28. doi: 10.1186/s12916-018-1005-y.
- Bellon JA, Conejo-Ceron S, Moreno-Peral P, King M, Nazareth I, Martin-Perez C, Fernandez-Alonso C, Rodriguez-Bayon A, Fernandez A, Aiarzaguena JM, Monton-Franco C, Ibanez-Casas I, Rodriguez-Sanchez E, Ballesta-Rodriguez MI, Serrano-Blanco A, Gomez MC, LaFuente P, Munoz-Garcia Mdel M, Minguez-Gonzalo P, Araujo L, Palao D, Bully P, Zubiaga F, Navas-Campana D, Mendive J, Aranda-Regules JM, Rodriguez-Morejon A, Salvador-Carulla L, de Dios Luna J. Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized Trial. Ann Intern Med. 2016 May 17;164(10):656-65. doi: 10.7326/M14-2653. Epub 2016 Mar 29.
- Bellon JA, Conejo-Ceron S, Moreno-Peral P, King M, Nazareth I, Martin-Perez C, Fernandez-Alonso C, Ballesta-Rodriguez MI, Fernandez A, Aiarzaguena JM, Monton-Franco C, Ibanez-Casas I, Rodriguez-Sanchez E, Rodriguez-Bayon A, Serrano-Blanco A, Gomez MC, LaFuente P, Del Mar Munoz-Garcia M, Minguez-Gonzalo P, Araujo L, Palao D, Espinosa-Cifuentes M, Zubiaga F, Navas-Campana D, Mendive J, Aranda-Regules JM, Rodriguez-Morejon A, Salvador-Carulla L, de Dios Luna J. Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study). BMC Psychiatry. 2013 Jun 19;13:171. doi: 10.1186/1471-244X-13-171.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS09/00081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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