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Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized TrialPreventing Major Depression in Primary Care

Juan Ángel Bellón, MD, PhD; Sonia Conejo-Cerón, PhD; Patricia Moreno-Peral, PhD; Michael King, MD, PhD; Irwin Nazareth, MD, PhD; Carlos Martín-Pérez, MD, PhD; Carmen Fernández-Alonso, MD, PhD; Antonina Rodríguez-Bayón, MD, PhD; Anna Fernández, PhD; José María Aiarzaguena, MD, PhD; Carmen Montón-Franco, MD, PhD; Inmaculada Ibanez-Casas, PhD; Emiliano Rodríguez-Sánchez, MD, PhD; María Isabel Ballesta-Rodríguez, MD, PhD; Antoni Serrano-Blanco, MD, PhD; María Cruz Gómez, PhD; Pilar LaFuente, MD; María del Mar Muñoz-García, PhD; Pilar Mínguez-Gonzalo, PhD; Luz Araujo, PhD; Diego Palao, MD, PhD; Paola Bully, PhD; Fernando Zubiaga, PhD; Desirée Navas-Campaña, PhD; Juan Mendive, MD, PhD; Jose Manuel Aranda-Regules, MD, PhD; Alberto Rodriguez-Morejón, PhD; Luis Salvador-Carulla, MD, PhD; and Juan de Dios Luna, PhD
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This article was published at www.annals.org on 29 March 2016.


From Centros de Salud El Palo y El Torcal, Distrito de Atención Primaria Málaga-Guadalhorce, Instituto de Investigación Biomédica de Málaga, Universidad de Málaga, Málaga, Spain; University College London, London, United Kingdom; Centro de Salud Marquesado, Área Nordeste de Granada, Centro de Investigaciones Biomédicas de Salud Mental de la Universidad de Granada, Universidad de Granada, Granada, Spain; Servicio de Programas Asistenciales, Unidad de Investigación de Atención Primaria, Gerencia Regional de Salud, Valladolid, Spain; Centros de Salud San José (Linares) y Federico del Castillo (Jaén), Servicio Andaluz de Salud, Jaén, Spain; Center for Disability Research and Policy and Brain and Mind Research Institute, University of Sydney, Sydney, Australia; Centro de Salud La Mina, Institut Català de la Salut, Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Hospital Parc Taulí, Servei de Salut Mental, Barcelona, Spain; Centro de Salud San Ignacio, Unidad de Investigación de Atención Primaria, Osakidetza, Bilbao, Spain; Centros de Salud Casablanca (Zaragoza), Arrabal (Zaragoza) y Andorra (Teruel), Unidad de Investigación de Atención Primaria, Instituto Aragonés de Ciencias de la Salud, Instituto de Investigación Sanitaria Aragón, Universidad de Zaragoza, Zaragoza, Spain; and Centro de Salud Miguel Armijo, Salamanca, Spain.

Acknowledgment: The authors thank the Primary Care District of Málaga, particularly Maximiliano Vilaseca, for its support. They also thank the Institute of Health Carlos III, the Biomedical Research Institute of Málaga, the European Union (European Regional Development Fund), the Andalusian Council of Health, and Bonaventura Bolíbar and the Spanish Network of Primary Care Research for their economic and logistic support. The authors thank all the patients and PCPs who participated in the trial.

Grant Support: By the Spanish Ministry of Health, the Institute of Health Carlos III, and the European Regional Development Fund (grants PS09/02272, PS09/02147, PS09/01095, PS09/00849, and PS09/00461); the Andalusian Council of Health (grant PI-0569-2010); the Spanish Network of Primary Care Research (grant RD06/0018); the Aragón group (grant RD06/0018/0020); the Bizkaya group (grant RD06/0018/0018); the Castilla-León group (grant RD06/0018/0027); the Mental Health Barcelona Group (grant RD06/0018/0017); and the Mental Health, Services and Primary Care Málaga group (grant RD06/0018/0039).

Disclosures: Dr. Serrano-Blanco reports grants from Ferrer International outside the submitted work. Authors not named here have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOf InterestForms.do?msNum=M14-2653.

Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.

Reproducible Research Statement:Study protocol: See www.biomedcentral.com/1471-244X/13/171. Statistical code and data set: Available from Dr. Bellón (e-mail, jabellon@uma.es).

Requests for Single Reprints: Juan Ángel Bellón, MD, PhD, Distrito de Atención Primaria Málaga-Guadalhorce, Unidad de Investigación, C/ Sevilla, 23, 3a Planta, 29009 Málaga, Spain; e-mail, jabellon@uma.es.

Current Author Addresses: Drs. Bellón, Conejo-Cerón, Moreno-Peral, Muñoz-García, Araujo, and Navas-Campaña: Distrito de Atención Primaria Málaga-Guadalhorce, Unidad de Investigación, C/ Sevilla, 23, 3a Planta, 29009 Málaga, Spain.

Dr. King: Division of Psychiatry, University College London, Charles Bell House, 67-73 Riding House Street, London W1W 7EH, United Kingdom.

Dr. Nazareth: Department of Primary Care & Population Health, University College London, Royal Free Site, Rowland Hill Street, London NW3, United Kingdom.

Dr. Martín-Pérez: Centro de Salud Marquesado, Distrito Sanitario Granada Nordeste, Avenida Mariana Pineda s/n, 18500 Granada, Spain.

Dr. Fernández-Alonso: Gerencia Regional de Salud de Castilla y León, Paseo de Zorrilla, 1, 47007 Valladolid, Spain.

Dr. Rodríguez-Bayón: Centro de Salud San José, Plaza Juanfra Garrido Romera s/n, 23700 Linares, Jaén, Spain.

Drs. Fernández and Salvador-Carulla: Centre for Disability Research and Policy, Brain and Mind Research Institute, Faculty of Health Sciences, University of Sydney, Cumberland Campus 75 East Street, Lidcombe NSW 2141, Australia.

Dr. Aiarzaguena: Centro de Salud San Ignacio, Larrakotorre Kalea, 9, 48015 Bilbao, Bizkaia, Spain.

Dr. Montón-Franco: Centro de Salud Casablanca, C/ Viñedo Viejo, 10, 50009 Zaragoza, Spain.

Dr. Ibanez-Casas: Centro de Investigación Biomédica en Red de Salud Mental de la Universidad de Granada, Facultad de Medicina PTS Avda. de la Investigación (Departamento de Psiquiatría Torre A Planta 9a), 11, 18016 Granada, Spain.

Dr. Rodríguez-Sánchez: Centro de Salud La Alamedilla, Unidad Investigación, Avenida Comuneros 27-31, 37003 Salamanca, Spain.

Dr. Ballesta-Rodríguez: Centro de Salud Federico del Castillo, C/ Ramón Espantaleón s/n, 23005 Jaén, Spain.

Dr. Serrano-Blanco: Parc Sanitari Sant Joan de Déu, C/ Dr. Antoni Pujadas, 42, 08830 Sant Boi de Llobregat, Barcelona, Spain.

Drs. Gómez and Bully: Unidad de Investigación de Atención Primaria, C/ Luis Power, 18-4o Planta, 48014 Bilbao, Spain.

Dr. LaFuente: Centro de Salud Andorra, C/ de Huesca, 0, 44500, Teruel, Spain.

Dr. Mínguez-Gonzalo: Gerencia Regional de Salud de Castilla y León, Unidad de Investigación, Paseo de Zorrilla, 1, 47007 Valladolid, Spain.

Dr. Palao: Hospital Parc Taulí, Servei de Salut Mental, Parc Taulí, 1, 08208 Sabadell, Barcelona, Spain.

Dr. Zubiaga: Centro de Salud Arrabal, Unidad de Investigación de Atención Primaria, Andador Aragues Puerto, 2-4, 50015, Zaragoza, Spain.

Dr. Mendive: Centro de Salud La Mina, C/ Mar s/n, 08930 Barcelona, Spain.

Dr. Aranda-Regules: Centro San Andrés-Torcal, C/ José Palanca, 29003 Málaga, Spain.

Dr. Rodriguez-Morejón: Departamento de Personalidad, Evaluación y Tratamiento Psicologico de la Facultad de Psicologia de la Universidad de Málaga, Campus Teatinos s/n, 29590 Málaga, Spain.

Dr. Luna: Departamento de Bioestadística, Facultad de Medicina, Universidad de Granada Parque Tecnológico de Ciencias de la Salud, Avda de la Investigación 11 18016, Granada, Spain.

Author Contributions: Conception and design: J.Á. Bellón, S. Conejo-Cerón, P. Moreno-Peral, M. King, I. Nazareth, C. Martín-Pérez, C. Fernández-Alonso, A. Rodríguez-Bayón, A. Fernández, J.M. Aiarzaguena, C. Montón-Franco, M.I. Ballesta-Rodríguez, I. Ibanez-Casas, E. Rodríguez-Sánchez, A. Serrano-Blanco, M.C. Gómez, P. LaFuente, M.M. Muñoz-García, P. Mínguez-Gonzalo, L. Araujo, D. Palao, P. Bully, F. Zubiaga, D. Navas-Campaña, J. Mendive, J.M. Aranda-Regules, A. Rodriguez-Morejón, L. Salvador-Carulla, J.D. Luna.

Analysis and interpretation of the data: J.Á. Bellón, M. King, I. Nazareth, A. Fernández, J.D. Luna.

Drafting of the article: J.Á. Bellón.

Critical revision of the article for important intellectual content: J.Á. Bellón, S. Conejo-Serón, P. Moreno-Peral, M. King, I. Nazareth, C. Martín-Pérez, C. Fernández-Alonso, A. Rodríguez-Bayón, A. Fernández, J.M. Aiarzaguena, C. Montón-Franco, I. Ibanez-Casas, E. Rodríguez-Sánchez, M.I. Ballesta-Rodríguez, A. Serrano-Blanco, D. Palao, J. Mendive, J.M. Aranda-Regules, A. Rodríguez-Morejón, L. Salvador-Carulla, J.D. Luna.

Final approval of the article: J.Á Bellón, S. Conejo-Cerón, P. Moreno-Peral, M. King, I. Nazareth, C. Martín-Pérez, C. Fernández-Alonso, A. Rodríguez-Bayón, A. Fernández, J.M. Aiarzaguena, C. Montón-Franco, I. Ibanez-Casas, E. Rodríguez-Sánchez, M.I. Ballesta-Rodríguez, A. Serrano-Blanco, M.C. Gómez, P. LaFuente, M.M. Muñoz-García, P. Mínguez-Gonzalo, L. Araujo, D. Palao, P. Bully, F. Zubiaga, D. Navas-Campaña, J. Mendive, J.M. Aranda-Regules, A. Rodriguez-Morejón, L. Salvador-Carulla, J.D. Luna.

Statistical expertise: J.A. Bellón, A. Fernández, J.D. Luna.

Obtaining of funding: J.Á. Bellón, C. Martín-Pérez, C. Fernández-Alonso, L. Salvador-Carulla, C. Montón-Franco, J.M. Aiarzaguena.

Administrative, technical, or logistic support: S. Conejo-Cerón, P. Moreno-Peral, I. Ibanez-Casas, M.C. Gómez, M.M. Muñoz-García, P. Bully, D. Navas-Campaña, P. LaFuente, P. Mínguez-Gonzalo, L. Araujo, F. Zubiaga.

Collection and assembly of data: S. Conejo-Cerón, P. Moreno-Peral, I. Ibanez-Casas, M.C. Gómez, P. LaFuente, M.M. Muñoz-García, P. Mínguez-Gonzalo, L. Araujo, F. Zubiaga, P. Bully, D. Navas-Campaña.


Ann Intern Med. 2016;164(10):656-665. doi:10.7326/M14-2653
© 2016 American College of Physicians
Text Size: A A A

Background: Not enough is known about universal prevention of depression in adults.

Objective: To evaluate the effectiveness of an intervention to prevent major depression.

Design: Multicenter, cluster randomized trial with sites randomly assigned to usual care or an intervention. (ClinicalTrials.gov: NCT01151982)

Setting: 10 primary care centers in each of 7 cities in Spain.

Participants: Two primary care physicians (PCPs) and 5236 nondepressed adult patients were randomly sampled from each center; 3326 patients consented and were eligible to participate.

Intervention: For each patient, PCPs communicated individual risk for depression and personal predictors of risk and developed a psychosocial program tailored to prevent depression.

Measurements: New cases of major depression, assessed every 6 months for 18 months.

Results: At 18 months, 7.39% of patients in the intervention group (95% CI, 5.85% to 8.95%) developed major depression compared with 9.40% in the control (usual care) group (CI, 7.89% to 10.92%) (absolute difference, −2.01 percentage points [CI, −4.18 to 0.16 percentage points]; P = 0.070). Depression incidence was lower in the intervention centers in 5 cities and similar between intervention and control centers in 2 cities.

Limitation: Potential self-selection bias due to nonconsenting patients.

Conclusion: Compared with usual care, an intervention based on personal predictors of risk for depression implemented by PCPs provided a modest but nonsignificant reduction in the incidence of major depression. Additional study of this approach may be warranted.

Primary Funding Source: Institute of Health Carlos III.

Figures

Grahic Jump Location
Figure 1.

Study flow diagram.

CIDI = Composite International Diagnostic Interview; PCP = primary care physician.

* Systematic random sampling from the PCPs' appointment lists at random starting points for each day and without replacement.

† Patients who attended the respective evaluation point but did not attend any previous one.

‡ Analyses done with multiple imputation to account for missing outcomes (269 intervention and 279 control patients had missing outcomes at 18 mo).

Grahic Jump Location
Grahic Jump Location
Figure 2.

Proportion of patients with depression at 18 mo adjusted for probability of depression at baseline and stratified by city and center.

Ctrl = control; Int = intervention.

Grahic Jump Location

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