Corresponding Author: Charles M. Morin, PhD, École de Psychologie, Université Laval, 2325, rue des Bibliothèques, Québec, QC G1V 0A6, Canada (cmorin@psy.ulaval.ca).
Accepted for Publication: April 18, 2020.
Published Online: July 8, 2020. doi:10.1001/jamapsychiatry.2020.1767
Author Contributions: Drs Morin and Edinger had access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Morin and Edinger were principal investigators.
Concept and design: Morin, Edinger, Krystal, Belanger.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Morin, Edinger, Beaulieu-Bonneau, Simmons.
Critical revision of the manuscript for important intellectual content: Morin, Beaulieu-Bonneau, Ivers, Krystal, Guay, Belanger, Cartwright, Lamy, Busby.
Statistical analysis: Ivers.
Obtained funding: Morin, Edinger, Krystal.
Administrative, technical, or material support: Morin, Edinger, Beaulieu-Bonneau, Krystal, Simmons, Lamy.
Supervision: Morin, Edinger, Ivers, Guay, Belanger, Lamy.
Conflict of Interest Disclosures: Dr Morin has served as a consultant for Abbot, Eisai, Merck, Philips, and Weight Watchers and received research support from Idorsia and Canopy Health. Dr Edinger has received research support from Merck and Philips/Respironics. Ms Cartwright received research grant support from the National Institutes of Health, Janssen, Jazz Axsome, and Reveal Biosensors and served as a consultant to Eisai, Ferring, Galderma, Harmony Biosciences, Idorsia, Jazz, Janssen, Takeda, Merck, Neurocrine, Pernix, and Physician’s Seal. Dr Krystal reported grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Axsome, and Reveal Biosensors; grants and personal fees from Janssen, Jazz, personal fees from Evecxia; and personal fees from Sage, Ferring, Galderma, Harmony Biosciences, Eisai, Idorsia, Neurocrine, Merck, and Takeda outside the submitted work. No other disclosures were reported.
Funding/Support: This study was funded by the National Institute of Mental Health (MH091053).
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Information: The Data and Safety Monitoring Board (DSMB) was composed of 3 members including Daniel Almirall (Chair), Vaughn McCall, and Richard Bootzin. The DSMB committee was responsible for safeguarding the interests of study participants, assessing the safety and efficacy of study procedures, and monitoring the overall conduct of the study. The DSMB completed an annual review of the trial conduct. This committee was independent from the sponsor and declared no competing interests.