2026-05-17T00:18:33Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/229332024-11-28T20:21:46Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967

00925njm 22002777a 4500 dc Navarro, Capilla author Yáñez, Aina M author Garcia, Aurora author Seguí, Andrea author Gazquez, Francisco author Marino, Jose Antonio author Ibarra, Olga author Serrano-Ripoll, Maria Jesus author Gomez-Juanes, Rocío author Bennasar-Veny, Miquel author Salva, Joan author Olivan, Barbara author Roca, Miquel author Gili, Margalida author Garcia Toro, Mauro author 2020-11-06 Introduction: Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions. Objective: The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD. Methods: This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire. Discussion: Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures. Navarro C, Yañez AM, Garcia A, Segui A, Gazquez F, Marino JA, et al. Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic A randomized clinical trial protocol. Medicine (Baltimore). 2020 Nov 06;99(45). 10.1097/MD.0000000000022958 1536-5964 0025-7974 Medicine http://hdl.handle.net/20.500.13003/16552 33157937 L633368617 2-s2.0-85095801161 https://hdl.handle.net/20.500.12105/22933 588168200031 COVID-19 Mindfulness-based cognitive therapy Multicomponent lifestyle program Treatment-resistant depression Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic A randomized clinical trial protocol