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Background: An estimated 280 million individuals suffer from depression. Brief group interventions in Primary Healthcare Centres (PHCs) are recommended. One goal of these interventions is to educate people about healthy lifestyle habits, as they prevent the development of depression. This study aims to analyse the one-year follow-up results about the effectiveness of a Lifestyle Modification Programme (LMP) and an LMP plus Information and Communication Technologies (LMP + ICTs) when compared to Treatment as Usual (TAU)., Methods: We conducted an open-label, multicentre, pragmatic, randomised clinical trial. A total of 188 individuals that visited a general practitioner and met the inclusion criteria were randomised. LMP consisted of six weekly 90-minute group sessions focusing on lifestyle improvement. LMP + ICTs was a hybrid of the LMP format with the inclusion of a wearable smartwatch. We used linear mixed models (with a random intercept and an unstructured covariance) to evaluate the effectiveness of the interventions, and an intention-to-treat analysis and Multiple Imputation technique for handling missing data., Results: LMP + ICTs showed a statistically significant reduction on depressive symptoms (b = -2.68, 95 % CI = [-4.239, -1.133] p = .001) and sedentarism (b = -37.38, 95 % CI [-62.930, -11.833], p = .004) compared to TAU., Limitations: Most of the dropouts were due to time restrictions., Conclusions: In long-term, LMPs plus ICTs administered in PHCs to people suffering from depression were effective in reducing depressive symptomatology and sedentarism comparing to TAU. More research is needed to enhance adherence to lifestyle recommendations. These promising programmes could be easily implemented in PHCs., Trial Registration Number: ClinicalTrials.gov Registry (NCT03951350)., Competing Interests: Conflict of interest None., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

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)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)