Investigating Placebos and Controls Used in Large Language Model–Based Chatbot Intervention Trials: Protocol for a Methodological Review

Leo Druart   ^{1, 2} , PT, PhD ;   Vanda Faria   ^{1, 3, 4} , PhD ;   Marco Annoni   ⁵ , PhD ;   John Torous   ⁶ , MD ;   Moa Pontén   ^{7, 8} , PhD ;   Charlotte Blease   ^{1, 6} , PhD

¹ Participatory eHealth and Health Data Research Group, Department of Women’s and Children’s Health, Uppsala University, Uppsala, Uppsala, Sweden

² Department of Radiology, Warren Alpert Medical School, Brown University, Providence, RI, United States

³ Brain and Eye Pain Imaging Lab, Pain and Affective Neuroscience Center, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children’s Hospital and Harvard Medical School, Harvard University, Boston, MA, United States

⁴ Comprehensive Pain Center, Faculty of Medicine, University Hospital Carl Gustav Carus, Dresden, Saxony, Germany

⁵ Interdepartmental Center for Research Ethics and Integrity, National Research Council, Milan, Lazio, Italy

⁶ Department of Psychiatry, Beth Israel Deaconess Medical Center, Division of Digital Psychiatry, Harvard Medical School, Boston, MA, United States

⁷ Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Stockholm, Sweden

⁸ Stockholm Health Care Services, Stockholm, Stockholm, Sweden