000097147 001__ 97147 000097147 005__ 20210902121853.0 000097147 0247_ $$2doi$$a10.1097/MD.0000000000022958 000097147 0248_ $$2sideral$$a121121 000097147 037__ $$aART-2020-121121 000097147 041__ $$aeng 000097147 100__ $$aNavarro, C. 000097147 245__ $$aEffectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol 000097147 260__ $$c2020 000097147 5060_ $$aAccess copy available to the general public$$fUnrestricted 000097147 5203_ $$aINTRODUCTION: 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. 000097147 536__ $$9info:eu-repo/grantAgreement/ES/MCIU/RTI2018-093590-B-I00 000097147 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000097147 590__ $$a1.889$$b2020 000097147 591__ $$aMEDICINE, GENERAL & INTERNAL$$b99 / 169 = 0.586$$c2020$$dQ3$$eT2 000097147 592__ $$a0.59$$b2020 000097147 593__ $$aMedicine (miscellaneous)$$c2020$$dQ2 000097147 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000097147 700__ $$aYáñez, A.M. 000097147 700__ $$aGarcia, A. 000097147 700__ $$aSeguí, A. 000097147 700__ $$aGazquez, F. 000097147 700__ $$aMarino, J.A. 000097147 700__ $$aIbarra, O. 000097147 700__ $$aSerrano-Ripoll, M.J. 000097147 700__ $$aGomez-Juanes, R. 000097147 700__ $$aBennasar-Veny, M. 000097147 700__ $$aSalva, J. 000097147 700__ $$0(orcid)0000-0001-6565-9699$$aOliván, B.$$uUniversidad de Zaragoza 000097147 700__ $$aRoca, M. 000097147 700__ $$aGili, M. 000097147 700__ $$aGarcia-Toro, M. 000097147 7102_ $$14009$$2740$$aUniversidad de Zaragoza$$bDpto. Psicología y Sociología$$cÁrea Psicología Social 000097147 773__ $$g99, 45 (2020), e22958 [8 pp]$$pMedicine (Baltim.)$$tMedicine$$x0025-7974 000097147 8564_ $$s257503$$uhttps://zaguan.unizar.es/record/97147/files/texto_completo.pdf$$yVersión publicada 000097147 8564_ $$s36793$$uhttps://zaguan.unizar.es/record/97147/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000097147 909CO $$ooai:zaguan.unizar.es:97147$$particulos$$pdriver 000097147 951__ $$a2021-09-02-10:31:18 000097147 980__ $$aARTICLE