Clinical trial NCT06815653: Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs
Official title: Digital Intervention for Psychedelic Preparation (DIPP): A Randomised Controlled Feasibility Trial Comparing Meditation and Music-Based Programs in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: psilocybin
meditation
preparation
digital
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Recruitment efficiency
timeFrame: Assessed at Visit 4 (2 weeks post-dose)
measure: Study retention
timeFrame: Assessed at Visit 4 (2 weeks post-dose)
measure: DIPP intervention adherence
timeFrame: Assessed at Visit 2 (1 day pre-dose)
Secondary outcomes:
measure: DIPP platform feasibility as measured by the Subjective Feasibility of Intervention Scale (SFIS)
timeFrame: Administered at Visit 2 (1 day pre-dose)
measure: DIPP platform acceptability as measured by the Theoretical Framework of Acceptability Scale (TFA)
timeFrame: Administered at Visit 2 (1 day pre-dose)
measure: DIPP platform usability and engagement as measured by the System Usability Scale (SUS) and Mobile Application Rating Scale (MARS)
timeFrame: Administered at Visit 2 (1 day pre-dose)
measure: Psychedelic Preparedness as measured using the Psychedelic Preparedness Scale (PPS)
timeFrame: Administered at Visit 1 and 2 (1 day pre-dose)
measure: Positive quality of acute psychedelic experience as measured by the Altered States Consciousness Questionnaire (11D-ASC)
timeFrame: Administered at Visit 3 (8 hours post-dose)
measure: Challenging psychological experience during the psychedelic experience as measured by the Challenging Experience Questionnaire (CEQ)
timeFrame: Administered at Visit 3 (8 hours post-dose)
measure: Mental wellbeing as measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: Administered at Visit 1, 2, 3 and 4 (2 weeks post-dose)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References: