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

NCT ID: NCT06815653

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-31

Brief Summary

This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences. Forty healthy volunteers will be randomly assigned to either a meditation-based intervention or a music-based control condition. Both groups will follow identical program structures, with the key distinction being their daily practice focus: meditation or music listening. Following the 21-day preparation period, participants will undergo a supervised 25 mg psilocybin session at University College London. Assessment visits include an in-person follow-up at 2 weeks post-session, followed by online assessments at 3, 6, and 9 months. The primary outcomes include operational feasibility (recruitment rates and participant retention) and intervention adherence (completion rates of DIPP program activities). Secondary outcomes include participant ratings of the platform's feasibility, acceptability, and usability, as well as changes in psychedelic preparedness, the quality of the psychedelic experience, and mental wellbeing over time.

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Meditation

Digital Intervention for Psychedelic Preparedness (DIPP) (Meditation) - A 21-day self-guided digital intervention based on four validated preparedness factors (Knowledge-Expectation, Psychophysical-Readiness, Intention-Preparation, and Support-Planning) (McAlpine et al., 2024). Participants will access a digital platform daily, completing structured, guided meditation sessions that progressively introduce and develop meditation techniques. The program includes daily mood assessments, journaling exercises, and weekly module-specific tasks.

Group Type: EXPERIMENTAL

Psilocybin 25mg

Intervention Type: DRUG

Psilocybin PEX010 is an investigational drug provided in capsule form, containing a 25 mg dose of synthetic psilocybin. The product is manufactured under Good Manufacturing Practice (GMP) standards to ensure purity, potency, and consistency. Each participant will receive a single oral dose of 25 mg psilocybin in a hydroxypropyl methylcellulose (HPMC) capsule. The intervention is administered once during the study session, with the effects expected to last approximately 4 to 6 hours.

Music Listening

Digital Intervention for Psychedelic Preparedness (DIPP) (Music-listening control) - Identical to the meditation arm in duration, structure, and theoretical framework, but participants engage in music-listening sessions using the same background music as the meditation arm, without guided meditation instructions. All other components (mood assessments, journaling, weekly tasks) remain the same.

Group Type: ACTIVE_COMPARATOR

Psilocybin 25mg

Intervention Type: DRUG

Psilocybin PEX010 is an investigational drug provided in capsule form, containing a 25 mg dose of synthetic psilocybin. The product is manufactured under Good Manufacturing Practice (GMP) standards to ensure purity, potency, and consistency. Each participant will receive a single oral dose of 25 mg psilocybin in a hydroxypropyl methylcellulose (HPMC) capsule. The intervention is administered once during the study session, with the effects expected to last approximately 4 to 6 hours.

Interventions

Psilocybin 25mg

Psilocybin PEX010 is an investigational drug provided in capsule form, containing a 25 mg dose of synthetic psilocybin. The product is manufactured under Good Manufacturing Practice (GMP) standards to ensure purity, potency, and consistency. Each participant will receive a single oral dose of 25 mg psilocybin in a hydroxypropyl methylcellulose (HPMC) capsule. The intervention is administered once during the study session, with the effects expected to last approximately 4 to 6 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Aged 21-65 years. Limited psychedelic use (0-5 sessions involving a high/full dose, defined as producing noticeable psychoactive effects beyond microdosing; none in the past 6 months).

Minimal meditation experience (≤10 sessions exceeding 30 minutes; no retreats or regular practice).

Native English speaking. Normal or corrected-to-normal colour vision. Able and willing to provide informed consent. Able to engage with all study requirements, including in-person and remote sessions.

UK resident registered with a primary care practice. Agree to allow research team contact with primary/secondary care teams if needed.

Access to mobile smartphone.

Exclusion Criteria

Current or past psychiatric diagnosis (e.g., depression, anxiety) unless in clear remission for at least 5 years and assessed as low-risk.

Current or past psychotic or bipolar disorder diagnosis. First degree relative with psychotic or bipolar disorder diagnosis. Current or past behaviours, including attempts, planning or intention. Medically significant physical health conditions (e.g., cardiovascular disease, uncontrolled hypertension, epilepsy, migraines, focal scalp sensitivity, or any condition posing a safety risk).

Use of medications interacting with psilocybin (e.g., antipsychotics, SSRIs, SNRIs, TCAs, mood stabilisers).

Psychoactive drug use within 30 days (except nicotine or caffeine). Pregnancy, planning pregnancy, or breastfeeding. Participation in a drug trial within 6 months. MRI contraindications (e.g., metal implants, pacemakers, severe claustrophobia).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jeremy I Skipper

Role: CONTACT

dipp-project@ucl.ac.uk

+44 (0)20 7679 2000

Facility Contacts

Jeremy I Skipper

Role: primary

dipp-project@ucl.ac.uk

+44 (0)20 7679 2000

Other Identifiers

19113/003

Identifier Type: -

Identifier Source: org_study_id