000099066 001__ 99066 000099066 005__ 20230526092851.0 000099066 0247_ $$2doi$$a10.1136/bmjopen-2020-038457 000099066 0248_ $$2sideral$$a122321 000099066 037__ $$aART-2020-122321 000099066 041__ $$aeng 000099066 100__ $$0(orcid)0000-0003-2683-7346$$aAguilar-Latorre, A. 000099066 245__ $$aEffectiveness and cost-effectiveness of a lifestyle modification programme in the prevention and treatment of subclinical, mild and moderate depression in primary care: A randomised clinical trial protocol 000099066 260__ $$c2020 000099066 5060_ $$aAccess copy available to the general public$$fUnrestricted 000099066 5203_ $$aIntroduction 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. Methods and analysis 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 to 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. Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of Aragón (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. Trial registration number ClinicalTrials.gov Registry (NCT03951350). 000099066 536__ $$9info:eu-repo/grantAgreement/ES/DGA-FEDER/Another way to make Europe$$9info:eu-repo/grantAgreement/ES/ISCIII/PI18-01336 000099066 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/ 000099066 590__ $$a2.692$$b2020 000099066 591__ $$aMEDICINE, GENERAL & INTERNAL$$b64 / 169 = 0.379$$c2020$$dQ2$$eT2 000099066 592__ $$a1.131$$b2020 000099066 593__ $$aMedicine (miscellaneous)$$c2020$$dQ1 000099066 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000099066 700__ $$aNavarro, C. 000099066 700__ $$0(orcid)0000-0001-6565-9699$$aOliván-Blázquez, B.$$uUniversidad de Zaragoza 000099066 700__ $$aGervilla, E. 000099066 700__ $$0(orcid)0000-0002-5494-6550$$aMagallón Botaya, R.$$uUniversidad de Zaragoza 000099066 700__ $$aCalafat-Villalonga, C. 000099066 700__ $$aGarcía-Toro, M. 000099066 700__ $$0(orcid)0000-0001-5073-4465$$aBoira, S.$$uUniversidad de Zaragoza 000099066 700__ $$aSerrano-Ripoll, M.J. 000099066 7102_ $$14009$$2740$$aUniversidad de Zaragoza$$bDpto. Psicología y Sociología$$cÁrea Psicología Social 000099066 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000099066 7102_ $$14009$$2813$$aUniversidad de Zaragoza$$bDpto. Psicología y Sociología$$cÁrea Trabajo Social y Serv.Soc 000099066 773__ $$g10, 12 (2020), e038457 [10 pp]$$pBMJ Open$$tBMJ Open$$x2044-6055 000099066 8564_ $$s292786$$uhttps://zaguan.unizar.es/record/99066/files/texto_completo.pdf$$yVersión publicada 000099066 8564_ $$s3256034$$uhttps://zaguan.unizar.es/record/99066/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000099066 909CO $$ooai:zaguan.unizar.es:99066$$particulos$$pdriver 000099066 951__ $$a2023-05-26-08:13:20 000099066 980__ $$aARTICLE