Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/16552
Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic A randomized clinical trial protocol
Identifiers
ISSN: 0025-7974
eISSN: 1536-5964
WOS ID: 000588168200031
Scopus EID: 2-s2.0-85095801161
PMID: 33157937
Embase PUI: L633368617
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2020-11-06Document type
research articleCitation
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).Abstract
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.
Publisher version
https://dx.doi.org/10.1097/MD.0000000000022958Keywords
COVID-19mindfulness-based cognitive therapy
multicomponent lifestyle program
treatment-resistant depression
MeSH
Coronavirus InfectionsPragmatic Clinical Trials as Topic
Humans
Mindfulness
Pandemics
Depressive Disorder, Treatment-Resistant
Quality of Life
Cognitive Behavioral Therapy
Health Promotion
Healthy Lifestyle
Telemedicine
COVID-19
Surveys and Questionnaires
Pneumonia, Viral
DeCS
Ensayos Clínicos Pragmáticos como AsuntoTelemedicina
Promoción de la Salud
Atención Plena
COVID-19
Terapia Cognitivo-Conductual
Trastorno Depresivo Resistente al Tratamiento
Humanos
Calidad de Vida
Estilo de Vida Saludable
Encuestas y Cuestionarios
Neumonía Viral
Infecciones por Coronavirus
Pandemias
This item appears in following Docusalut collections
Atención Primaria de Mallorca - APMALL > Comunicación científicaInstituto de Investigación Sanitaria Islas Baleares - IDISBA > Comunicación científica