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Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials
  1. Irene Gómez-Gómez1,
  2. Emma Motrico1,2,
  3. Patricia Moreno-Peral2,3,4,
  4. Alina Rigabert1,
  5. Sonia Conejo-Cerón2,3,4,
  6. Manuel Ortega-Calvo5,6,
  7. José-Ignacio Recio2,7,
  8. Juan A Bellón2,3,4,8,9
  1. 1 Department of Psychology, Universidad Loyola Andalucia, Seville, Spain
  2. 2 Prevention and Health Promotion Research Network (redIAPP), ISCIII, Barcelona, Spain
  3. 3 Biomedical Research Institute of Malaga (IBIMA), Málaga, Spain
  4. 4 Research Unit of the Health District of Primary Care Málaga-Guadalhorce, Málaga, Spain
  5. 5 Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid, Spain
  6. 6 Department of Family Medicine, Primary Care Division of Seville, Seville, Spain
  7. 7 Institute of Biomedical Research of Salamanca (IBSAL), Primary Health Care Research Unit, La Alamedilla Health Center, Health Service of Castilla y León (SACyL), Salamanca, Spain
  8. 8 Department of Public Health and Psychiatry, University of Málaga (UMA), Málaga, Spain
  9. 9 El Palo Health Centre, Andalusian Health Service (SAS), Málaga, Spain
  1. Correspondence to Dr Emma Motrico; emotrico{at}


Introduction Many studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits—healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted.

Method and analysis MEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis.

Ethics and dissemination Ethical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression.

PROSPERO registration number CRD42018100253; Pre-results.

  • systematic review
  • meta-analysis
  • protocol study
  • depression
  • lifestyles
  • complex multiple-risk intervention

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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  • Contributors IGG is the guarantor. EM and JAB designed the study and the other authors (IGG, AR, PMP, SCC, MOC and JIR) collaborated in the design of the study. IGG prepared the initial protocol draft and EM and JAB revised the manuscript. All authors read, provided feedback, discussed and approved the final manuscript. All authors gave approval for the manuscript to be submitted.

  • Funding This study is supported by the Carlos III Health Institute, the Spanish Ministry of Economy and Competitiveness via a health research grant (PI15/01151; PI15/00762) through the Primary Care Prevention and Health Promotion Network (redIAPP, RD12/0005/0001; RD16/0007/0001), and by the EU ERDF funds (European Regional Development Fund).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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