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

NCT06815653 | Recruiting Phase 1

• 1 other identifier: 19113/003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

psilocybin; meditation; preparation; digital

Outcome Measures

Primary Outcomes (3)

• Recruitment efficiency

  Weekly rate of participant enrollment and randomisation. Success is defined as ≥1 participant per week (average) until target sample (N=40) achieved

  Assessed at Visit 4 (2 weeks post-dose)

• Study retention

  Percentage of randomised participants completing the 2-week post-dose follow-up assessment. Success is defined as ≥70% completion rate

  Assessed at Visit 4 (2 weeks post-dose)

• DIPP intervention adherence

  Task completion rates across three daily tasks (meditation/music practice, mood rating, journal entry) and two weekly tasks. Success is defined as ≥70% of participants achieving an average completion rate of ≥70% across all required tasks

  Assessed at Visit 2 (1 day pre-dose)

Secondary Outcomes (7)

• DIPP platform feasibility as measured by the Subjective Feasibility of Intervention Scale (SFIS)

  Administered at Visit 2 (1 day pre-dose)

• DIPP platform acceptability as measured by the Theoretical Framework of Acceptability Scale (TFA)

  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)

  Administered at Visit 2 (1 day pre-dose)

• Psychedelic Preparedness as measured using the Psychedelic Preparedness Scale (PPS)

  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)

  Administered at Visit 3 (8 hours post-dose)

Study Arms (2)

Meditation

EXPERIMENTAL

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.

Drug: Psilocybin 25mg

Music Listening

ACTIVE COMPARATOR

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.

Drug: Psilocybin 25mg

Interventions

Psilocybin 25mg 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.

Meditation; Music Listening

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, United Kingdom

RECRUITING

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Jeremy I Skipper

CONTACT

+44 (0)20 7679 2000; dipp-project@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups: a meditation-based preparation group or a music-listening control group. Both groups will engage in their assigned activity daily for 21 days leading up to a single psilocybin session, where they will each receive a 25 mg oral dose of psilocybin.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 7, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available beginning 6 months after publication of the primary results and will remain available for 5 years. De-identified fMRI data will be deposited in a public repository as soon as institutional approvals permit. Other de-identified data (questionnaire, behavioural, hormonal, EEG, and ECG) and analytic code will be shared upon reasonable request to the corresponding author within this period, subject to a data-sharing agreement.
• Access Criteria: Qualified researchers affiliated with academic or healthcare institutions may request access to de-identified IPD and supporting information for scientifically sound, ethically approved analyses that align with the study's objectives. Requests must include a detailed research proposal, analysis plan, and evidence of ethical approval or exemption. Proposals will be reviewed by the study's data access committee to assess scientific merit, feasibility, and compliance with participant confidentiality. Approved users must sign a data-sharing agreement. Requests should be submitted via email to the corresponding author.

Locations

GB (1)