How Does Psilocybin Affect Daily Life Experience and Behavior? Protocol For a Multimethod Ambulatory Assessment Study Within a Clinical Trial of Psilocybin for Depression
Year: 2026
Type: preprint
Study design: Study Protocol
Abstract: Introduction: Although psilocybin has shown promise for treating depression, responses vary considerably, with some individuals experiencing limiting improvement and even adverse effects. Research has largely relied on assessments conducted at discrete time points, providing limited insight into how post-psilocybin change unfolds in everyday life. The Dial-In study aims to characterize daily-life processes associated with differential responses to psilocybin, including factors associated with improvement or worsening following challenging dosing experiences. Methods and Analysis: Dial-In is a prospective, observational, multi-method longitudinal study embedded within a clinical trial administering 25 mg of psilocybin to up to 141 adults with major depressive disorder. Ambulatory assessments combine ecological momentary assessment (EMA) and voice diaries for 14 days pre- and post- dosing, and passive audio sampling via the Electronically Activated Recorder (EAR) for three four-day periods to characterize everyday affect, behavior, reflections, and social interactions. Outcomes include depressive symptoms, psychological well-being, and psychedelic-related adverse effects assessed through eight weeks post-dose. Analyses will examine whether affective sudden gains and losses, social support, interpersonal conflict, conversational focus, reflection and rigidity predict differential outcomes. Additional analyses will test whether these factors moderate associations between challenging dosing experiences and clinical outcomes. Ethics and Dissemination: The project was approved by WCG Institutional Review Board, with Emory University relying on WCG as the reviewing board. All participants provide written informed consent. Findings will be disseminated through peer-reviewed publications and scientific presentations.
Source: medRxiv
Language: English
Subfield: Clinical Psychology
Field: Psychology
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7225880331
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