Levin, Jennifer B. http://orcid.org/0000-0003-1214-0636
Briggs, Farren http://orcid.org/0000-0002-4037-4731
Blixen, Carol
Bauer, Mark
Einstadter, Douglas
Albert, Jeffrey M.
Weise, Celeste
Woods, Nicole
Fuentes-Casiano, Edna
Cassidy, Kristin A.
Rentsch, Julie
Sarna, Kaylee
Sajatovic, Martha
Funding for this research was provided by:
Foundation for the National Institutes of Health (R01MH119487)
Article History
Received: 12 April 2022
Accepted: 6 July 2022
First Online: 4 August 2022
Declarations
:
: Case Western Reserve University’s (CWRU) IRB will serve as the IRB of Record (IRB ID STUDY20210857). The Metro IRB will rely on the CWRU IRB (IRB21-00681). Informed consent will be obtained from all SAB members, RCT participants, and qualitative interview participants by a research assistant, and all work will be conducted consistent with IRB approval at the relevant sites. Any substantial protocol modification will be approved by the NIMH prior to obtaining IRB approval. Amendments will be submitted to the IRB for all protocol modifications and the Clinical Trials Registry will be updated subsequent to IRB approval.
: Not applicable.
: M.S. has research grants from Otsuka, Alkermes, Nuromate, the International Society of Bipolar Disorders (ISBD), National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC). M.S. is a consultant to Alkermes, Otsuka, Janssen, Neurocrine, Bracket, Health Analytics and Frontline Medical Communications and has received publication royalties from Springer Press, Johns Hopkins University Press, Oxford Press, UpToDate. J. L. has research grant support from the National Institutes of Health (NIH). The remaining authors declare that they have no competing interests.