Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs

Growing evidence demonstrates the therapeutic potential of psychedelic substances, particularly psilocybin, in addressing mental health challenges and enhancing psychological well-being. While psychedelic experiences can catalyse profound positive changes, they can also be psychologically challenging and potentially destabilising, underscoring the need for thorough preparation. Studies consistently show that an individual's psychological state prior to psychedelic administration significantly influences both the acute experience and its lasting benefits. However, structured preparation protocols designed to optimise this pre-psychedelic state remain understudied despite their crucial role in therapeutic outcomes.

Digital health interventions offer a promising solution for delivering standardised preparation protocols at scale. Meditation-based approaches warrant particular investigation, as they systematically cultivate both immediate psychological states and enduring traits (e.g. non-judgemental acceptance) beneficial for psychedelic experiences. Through regular practice, meditation promotes trait-like metacognitive awareness, emotional regulation, and tolerance of uncertainty - qualities particularly valuable for navigating altered states of consciousness. These benefits are supported by neuroscientific evidence showing that meditation and psychedelics influence similar brain networks and mechanisms. While traditional meditation training often requires substantial time investment and in-person instruction, digital platforms can provide efficient structured guidance without the need for face-to-face support from a trained instructor, while maintaining essential elements of practice. This combination of accessibility and evidence-based benefits makes digital meditation platforms particularly well-suited for preparing individuals for psychedelic experiences.

This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day self-guided program. Forty healthy volunteers will be randomised 1:1 to either a meditation-based intervention or music-based control condition. Both groups will engage with identical program structures, differing only in their daily practice (meditation versus music listening). Following preparation, all participants will undergo a supervised 25 mg psilocybin session at University College London, with follow-up assessments conducted in person at 2 weeks and online at 3, 6, and 9 months post-intervention.

The primary outcomes address two key aspects of feasibility: operational feasibility and intervention adherence. Operational feasibility evaluates study-wide metrics, including recruitment efficiency (target ≥1 participant per week) and participant retention (target ≥70% completion through the 2-week post-dose follow-up). Intervention adherence focuses on participant engagement with the DIPP activities (meditation or music listening), assessed through completion rates for daily sessions, mood check-ins, journal entries, and weekly tasks, with a target of ≥70% of participants achieving an average completion rate of 70% or higher. Secondary outcomes, reported descriptively for both conditions, include implementation measures such as subjective feasibility (SFIS), acceptability (TFA), and usability (SUS/MARS) ratings. Efficacy measures assess changes in psychedelic preparedness (PPS) from baseline to post-DIPP intervention, the qualities of the acute psychedelic experience (11-Dimensional Altered States of Consciousness Scale \[11D-ASC\] and Challenging Experience Questionnaire \[CEQ\]) following dosing, and changes in mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale \[WEMWBS\]) from baseline through the 2-week post-dose follow-up.

As such, this study will investigate the feasibility of implementing a digital preparation protocol within a research setting, while gathering preliminary data on engagement, acceptability, and potential efficacy. The findings will inform refinements to the DIPP platform and protocol, supporting the development of accessible, standardised preparation methods for psychedelic research and therapy as the field continues to expand into diverse clinical and community-based settings.

• DIPP platform feasibility as measured by the Subjective Feasibility of Intervention Scale (SFIS) [Срок оценки: Administered at Visit 2 (1 day pre-dose)]
• DIPP platform acceptability as measured by the Theoretical Framework of Acceptability Scale (TFA) [Срок оценки: Administered at Visit 2 (1 day pre-dose)]
• DIPP platform usability and engagement as measured by the System Usability Scale (SUS) and Mobile Application Rating Scale (MARS) [Срок оценки: Administered at Visit 2 (1 day pre-dose)]
• Psychedelic Preparedness as measured using the Psychedelic Preparedness Scale (PPS) [Срок оценки: Administered at Visit 1 and 2 (1 day pre-dose)]
• Positive quality of acute psychedelic experience as measured by the Altered States Consciousness Questionnaire (11D-ASC) [Срок оценки: Administered at Visit 3 (8 hours post-dose)]
• Challenging psychological experience during the psychedelic experience as measured by the Challenging Experience Questionnaire (CEQ) [Срок оценки: Administered at Visit 3 (8 hours post-dose)]
• Mental wellbeing as measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [Срок оценки: Administered at Visit 1, 2, 3 and 4 (2 weeks post-dose)]