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

Introduction 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 dif...

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Autores principales:	Alejandra Aguilar-Latorre, Capilla Navarro, Bárbara Oliván-Blázquez, Elena Gervilla, Rosa Magallón Botaya, Catalina Calafat-Villalonga, Mauro García-Toro, Santiago Boira, María Jesús Serrano-Ripoll
Formato:	article
Lenguaje:	EN
Publicado:	BMJ Publishing Group 2020
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/b8727a6bd4f3475d8e558823d233af8c
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spelling	oai:doaj.org-article:b8727a6bd4f3475d8e558823d233af8c2021-11-18T02:30:07ZEffectiveness 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 protocol10.1136/bmjopen-2020-0384572044-6055https://doaj.org/article/b8727a6bd4f3475d8e558823d233af8c2020-12-01T00:00:00Zhttps://bmjopen.bmj.com/content/10/12/e038457.fullhttps://doaj.org/toc/2044-6055Introduction 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).Alejandra Aguilar-LatorreCapilla NavarroBárbara Oliván-BlázquezElena GervillaRosa Magallón BotayaCatalina Calafat-VillalongaMauro García-ToroSantiago BoiraMaría Jesús Serrano-RipollBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 10, Iss 12 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Alejandra Aguilar-Latorre Capilla Navarro Bárbara Oliván-Blázquez Elena Gervilla Rosa Magallón Botaya Catalina Calafat-Villalonga Mauro García-Toro Santiago Boira María Jesús Serrano-Ripoll 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
description	Introduction 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).
format	article
author	Alejandra Aguilar-Latorre Capilla Navarro Bárbara Oliván-Blázquez Elena Gervilla Rosa Magallón Botaya Catalina Calafat-Villalonga Mauro García-Toro Santiago Boira María Jesús Serrano-Ripoll
author_facet	Alejandra Aguilar-Latorre Capilla Navarro Bárbara Oliván-Blázquez Elena Gervilla Rosa Magallón Botaya Catalina Calafat-Villalonga Mauro García-Toro Santiago Boira María Jesús Serrano-Ripoll
author_sort	Alejandra Aguilar-Latorre
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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMJ Publishing Group
publishDate	2020
url	https://doaj.org/article/b8727a6bd4f3475d8e558823d233af8c
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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

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