Clinical trial NCT01151982: Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial
Official title: Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Primary prevention.
Primary health care.
Randomised controlled trial.
Lead sponsor: The Mediterranean Institute for the Advance of Biotechnology and Health Research
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Carlos III Health Institute
name: Andaluz Health Service
First posted: 2010-06-29
Enrollment: 3326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective is to measure the effectiveness of a new intervention for primary prevention of major depression based on the level and profile of risk of primary care attendees. Among the secondary objectives is to evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised controlled trial of a community intervention with cluster at the level of practice. It will be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The aim is to evaluate a new intervention for primary prevention of major depression based on patients' level and profile of risk. Family doctors in the intervention practices will provide the intervention for patients at risk. Patients at risk who are recruited in control practices will receive usual primary care. The main outcome is the accumulated incidence of major depression (measured by CIDI) during the follow-up. The investigators will assess main outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381 primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and health centre). The investigators shall also undertake multivariate gamma and quantile regression to assess respectively the cost-effectiveness and cost-utility of the new intervention versus usual care, estimating their standard errors by bootstrap.


Eligibility criteria: 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.

Primary outcomes:
measure: Accumulated incidence of major depression
timeFrame: 18 months
Secondary outcomes:
measure: Cost-effectiveness and cost-utility
timeFrame: 18 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Servicio Andaluz de Salud. Distrito Sanitario Málaga
city: Málaga
country: Spain
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.