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Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol

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, m...

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Autores principales: Navarro, Capilla, Yáñez, Aina M., Garcia, Aurora, Seguí, Andrea, Gazquez, Francisco, Marino, Jose Antonio, Ibarra, Olga, Serrano-Ripoll, Maria J., Gomez-Juanes, Rocio, Bennasar-Veny, Miquel, Salva, Joan, Oliván, Bárbara, Roca, Miquel, Gili, Margalida, Garcia-Toro, Mauro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7647547/
https://www.ncbi.nlm.nih.gov/pubmed/33157937
http://dx.doi.org/10.1097/MD.0000000000022958
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author Navarro, Capilla
Yáñez, Aina M.
Garcia, Aurora
Seguí, Andrea
Gazquez, Francisco
Marino, Jose Antonio
Ibarra, Olga
Serrano-Ripoll, Maria J.
Gomez-Juanes, Rocio
Bennasar-Veny, Miquel
Salva, Joan
Oliván, Bárbara
Roca, Miquel
Gili, Margalida
Garcia-Toro, Mauro
author_facet Navarro, Capilla
Yáñez, Aina M.
Garcia, Aurora
Seguí, Andrea
Gazquez, Francisco
Marino, Jose Antonio
Ibarra, Olga
Serrano-Ripoll, Maria J.
Gomez-Juanes, Rocio
Bennasar-Veny, Miquel
Salva, Joan
Oliván, Bárbara
Roca, Miquel
Gili, Margalida
Garcia-Toro, Mauro
author_sort Navarro, Capilla
collection PubMed
description 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. CLINICALTRIALS REGISTRATION NUMBER: NCT04428099
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spelling pubmed-76475472020-11-09 Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol Navarro, Capilla Yáñez, Aina M. Garcia, Aurora Seguí, Andrea Gazquez, Francisco Marino, Jose Antonio Ibarra, Olga Serrano-Ripoll, Maria J. Gomez-Juanes, Rocio Bennasar-Veny, Miquel Salva, Joan Oliván, Bárbara Roca, Miquel Gili, Margalida Garcia-Toro, Mauro Medicine (Baltimore) 5000 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. CLINICALTRIALS REGISTRATION NUMBER: NCT04428099 Lippincott Williams & Wilkins 2020-11-06 /pmc/articles/PMC7647547/ /pubmed/33157937 http://dx.doi.org/10.1097/MD.0000000000022958 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.
spellingShingle 5000
Navarro, Capilla
Yáñez, Aina M.
Garcia, Aurora
Seguí, Andrea
Gazquez, Francisco
Marino, Jose Antonio
Ibarra, Olga
Serrano-Ripoll, Maria J.
Gomez-Juanes, Rocio
Bennasar-Veny, Miquel
Salva, Joan
Oliván, Bárbara
Roca, Miquel
Gili, Margalida
Garcia-Toro, Mauro
Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol
title Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol
title_full Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol
title_fullStr Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol
title_full_unstemmed Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol
title_short Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol
title_sort effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during covid 19 pandemic: a randomized clinical trial protocol
topic 5000
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7647547/
https://www.ncbi.nlm.nih.gov/pubmed/33157937
http://dx.doi.org/10.1097/MD.0000000000022958
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