Identifying optimal responses to challenges related to expanding the perception box in psilocybin-assisted therapy
Abstract
Aims of the Project Psychedelics provide a unique opportunity to better understand the complex interplay of benefits and risks that accompany transformative, perception box-expanding experiences, and to maximize benefits while reducing risks. Such an understanding is essential to bringing psychedelics, as well as other perception box-expanding modalities, to scale as optimally and safely as possible. To address this need, here we seek funding to incorporate a suite of highly innovative assessment strategies into a large, planned and funded upcoming study of high dose psilocybin for major depressive disorder (MDD) (Study name elided for review: Hereafter referred to as “parent study”). Specifically, the novel work proposed in this project aims to (1) characterize precursors to deterioration vs. improvement (2) identify modifiable real-world variables linked with differential outcomes of psilocybin-induced perception box expansion, and (3) apply these to identify when challenging experiences lead to better vs. worse outcomes. The parent study that makes the proposed work possible will administer a single 25-mg dose of psilocybin to 141 adults with Major Depressive Disorder (MDD). Participants will be ethnically and socioeconomically diverse, recruited from community clinics associated with a behavioral health center in the US (location elided for review). The work being proposed in this application would add intensive, multi-modal ecological assessment of real-world social behaviors and psychological experiences during the 2 weeks prior to, and 2 weeks following, psilocybin administration. Using the resulting well-powered dataset, we will apply complex dynamic systems modeling, a method uniquely suited to computing sudden gains, losses, and their early warning signs, to meet study aims. Alongside traditional self-report measures, our dynamic systems analyses will be enriched by a cutting-edge assessment toolkit: Empirically observed real-world behavior: participants will wear the Electronically Activated Recorder (EAR), a method used extensively by our team, two weeks before, and at 1 and 4 weeks after dosing. The EAR is a smartphone app that records short samples of ambient sound while participants go about their daily lives. These data will allow us to identify risk and resilience factors based on objectively observed behaviors and social interactions, and to explore how observed behavioral variables predict both therapeutic gains and adverse effects (AEs) after psilocybin. Ecological Momentary Assessment (EMA): For 14 days before and 14 after dosing, participants will complete EMA about their psychological states 4x daily, including a nightly stream-of-consciousness voicediary assessing subjective perception box shifts. Enhanced assessment of post-acute AEs: We will administer a novel instrument previously developed by our research team to assess AEs related to cultural, spiritual, interpersonal, psychotherapeutic, metacognitive, and perceptual domains, uniquely relevant to shifts in the perception box but not yet addressed elsewhere in psychedelics research. We will use complex dynamic systems modeling to identify sudden gains and losses within longitudinal trajectories derived from EMA and EAR data, as well as “early warning signals” (fluctuations and changes in cumulative and local dynamic complexity within the time series). This modeling approach, validated in standard psychotherapy research, is ideally suited to identifying early predictors of improvement or deterioration in PAT.
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