Corresponding Authors: Ricardo Araya, MD, PhD, Centre for Global Mental Health, King’s College London, Five De Crespigny Park, London SE5 8AF, United Kingdom (firstname.lastname@example.org); Jaime Miranda, MD, PhD, Centro de Excelencia en Enfermedades Crónicas, Universidad Peruana Cayetano Heredia, Av Armendáriz 445, Miraflores, Lima 18, Perú (email@example.com).
Accepted for Publication: March 8, 2021.
Author Contributions: Dr Araya had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Joint first authors: Drs Araya and Menezes. Joint senior authors: Drs Mohr and Miranda.
Concept and design: Araya, Menezes, Garcia Claro, Diez-Canseco, Peters, Martins Castro, Begale, Mohr, Miranda.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Araya, Menezes, Garcia Claro, Daley, Quayle, Diez-Canseco, Santos, Rocha, Scotton, Fernandes, Begale, Mohr, Miranda.
Critical revision of the manuscript for important intellectual content: Araya, Menezes, Garcia Claro, Brandt, Diez-Canseco, Peters, Toyama, Aschar, Hidalgo-Padilla, Martins Castro, Cavero, Fernandes, Mohr, Miranda.
Statistical analysis: Araya, Menezes, Garcia Claro, Peters, Scotton, Fernandes.
Obtained funding: Araya, Menezes, Mohr, Miranda.
Administrative, technical, or material support: Araya, Menezes, Garcia Claro, Brandt, Quayle, Diez-Canseco, Santos, Aschar, Hidalgo-Padilla, Martins Castro, Cavero, Rocha, Scotton, Begale, Mohr, Miranda.
Supervision: Araya, Menezes, Garcia Claro, Brandt, Quayle, Diez-Canseco, Cavero, Miranda.
Other - quantitative aspects of the trial design: Peters.
Conflict of Interest Disclosures: Dr Araya reported a pending patent for CONEMO (the digital intervention used in both studies). Dr Menezes reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Brandt reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Diez-Canseco reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Hidalgo-Padilla reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Cavero reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Rocha reported receipt of grants from NIMH during the conduct of the study. Dr Scotton reported receipt of grants from NIMH during the conduct of the study. Dr Mohr reported receipt of grants from NIMH during the conduct of the study; personal fees from Otsuka Pharmaceuticals, from Apple Inc, Pear Therapeutics, and One Mind Foundation; and other from Adaptive Health Inc Equity Interest outside the submitted work. Dr Miranda reported receipt of grants from NIMH during the conduct of the study. No other disclosures were reported.
Funding/Support: This project was funded by NIMH (U19MH098780).
Role of the Funder/Sponsor: NIMH researchers composed the data and safety monitoring board (DSMB) and executive committee and took part in reviewing and approving research protocols and DSMB reports. The funder did not take part in the data collection or analysis. Funders did not participate in the preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank all of the staff, especially the nurses, and the study participants.
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