{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T13:48:34Z","timestamp":1776952114786,"version":"3.51.4"},"reference-count":80,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2020,12,28]],"date-time":"2020-12-28T00:00:00Z","timestamp":1609113600000},"content-version":"unspecified","delay-in-days":27,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI18\/01336"],"award-info":[{"award-number":["PI18\/01336"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,11,19]]},"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programmes (LMPs), taking into account personal factors and facilitators. The main objective of this protocol is to analyse the clinical effectiveness, cost-effectiveness and cost utility of an LMP and an LMP with information and communication technologies (ICTs) as adjunctive treatment for depression in primary care patients. The secondary objectives are to analyse the clinical effectiveness in the subgroup that presents comorbidity and to analyse the correlation between personal factors on health behaviour and lifestyle patterns.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A randomised, multicenter pragmatic clinical trial with three parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: (1) Usual antidepressant treatment with psychological advice and\/or psychotropic drugs prescribed by the general practitioner (treatment as usual (TAU)). (2) TAU+LMP. A programme to be imparted in six weekly 90-minute group sessions, intended to improve the following aspects: behavioural activation+daily physical activity+adherence\u2009to the Mediterranean diet pattern+sleep hygiene+careful exposure to sunlight. (3) TAU+LMP+ICTs: healthy lifestyle recommendations (TAU+LMP)+monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal factors on health behaviour, social support, lifestyle patterns and chronic comorbid pathology. Data will be collected before and after the intervention, with 6-month and 12-month follow-ups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has been approved by the Clinical Research Ethics Committee of Arag\u00f3n (approval number: C.P.-C.I. PI18\/286) and the Research Ethics Committee of the Balearic Islands (IB3950\/19 PI). Data distribution will be anonymous. Results will be disseminated via conferences and papers published in peer-reviewed, open-access journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Registry (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT03951350\">NCT03951350<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-038457","type":"journal-article","created":{"date-parts":[[2020,12,28]],"date-time":"2020-12-28T12:37:30Z","timestamp":1609159050000},"page":"e038457","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["Effectiveness and cost-effectiveness of a lifestyle modification programme in the prevention and treatment of subclinical, mild and moderate depression in primary care: a randomised clinical trial protocol"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct03951350","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2683-7346","authenticated-orcid":false,"given":"Alejandra","family":"Aguilar-Latorre","sequence":"first","affiliation":[{"name":"Primary Health Care Research Group of Arag\u00f3n (GAIAP), Institute for Health Research Arag\u00f3n (IIS Arag\u00f3n), Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Capilla","family":"Navarro","sequence":"additional","affiliation":[{"name":"Department of Psychology, University of the Balearic Islands, Palma de Mallorca, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B\u00e1rbara","family":"Oliv\u00e1n-Bl\u00e1zquez","sequence":"additional","affiliation":[{"name":"Primary Health Care Research Group of Arag\u00f3n (GAIAP), Institute for Health Research Arag\u00f3n (IIS Arag\u00f3n), Zaragoza, Spain"},{"name":"Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Gervilla","sequence":"additional","affiliation":[{"name":"Department of Psychology, University of the Balearic Islands, Palma de Mallorca, Spain"},{"name":"Statistic and psychometric procedures implemented in Health Sciences Research Group, Balearic Islands Health Research Institute (IdISBa), Palma de Mallorca, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa","family":"Magall\u00f3n Botaya","sequence":"additional","affiliation":[{"name":"Primary Health Care Research Group of Arag\u00f3n (GAIAP), Institute for Health Research Arag\u00f3n (IIS Arag\u00f3n), Zaragoza, Spain"},{"name":"Department of Medicine, Psychiatry and Dermatology, University of Zaragoza, Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catalina","family":"Calafat-Villalonga","sequence":"additional","affiliation":[{"name":"Department of Psychology, University of the Balearic Islands, Palma de Mallorca, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mauro","family":"Garc\u00eda-Toro","sequence":"additional","affiliation":[{"name":"Mental disorders of high prevalence Research Group (TRAMAP), Balearic Islands Health Research Institute (IdISBa), Palma de Mallorca, Spain"},{"name":"Department of Medicine, University of the Balearic Islands, Palma de Mallorca, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Santiago","family":"Boira","sequence":"additional","affiliation":[{"name":"Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Jes\u00fas","family":"Serrano-Ripoll","sequence":"additional","affiliation":[{"name":"Department of Psychology, University of the Balearic Islands, Palma de Mallorca, Spain"},{"name":"Research in Preventive Activities and Promotion and in Cancer Illes Balears (GRAPP-CAIB), Balearic Islands Health Research Institute (IdISBa), Palma de Mallorca, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,12,28]]},"reference":[{"key":"2025121601190132000_10.12.e038457.1","doi-asserted-by":"crossref","unstructured":"Ferrari AJ , Charlson FJ , Norman RE , et al . 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