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Understanding Music and Mindfulness Preferences in Psilocybin-Assisted Psychotherapy

NCT07373535 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-22

No results posted yet for this study

Summary

The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how people respond to psilocybin treatment.

The main questions it aims to answer are:

* Is it feasible to conduct a patient-preference randomized trial of psilocybin-assisted psychotherapy?
* Does receiving a preferred psychotherapy style improve treatment experiences or outcomes?
* How do music-centered and mindfulness-centered PAP approaches compare in their effects on improving mood and well-being?

Researchers will compare music-centered PAP to mindfulness-centered PAP to see if aligning psychotherapy with individual preferences is a practical and potentially beneficial approach for improving treatment efficacy and tolerability.

Participants will:

* Be adults with treatment-resistant depression
* Receive two 25 mg psilocybin (PEX010, Filament Health) sessions, spaced four weeks apart
* Experience one session with music-centered psychotherapy and one with mindfulness-centered psychotherapy
* Before treatment, rate their preference for the two psychotherapy approaches
* Be randomly assigned to receive their preferred or non-preferred approach first, followed by the other
* Complete preparation and integration sessions before and after each psilocybin session

This feasibility trial will also collect information on participants' cultural and personal factors influencing psychotherapy preferences using a modified Cultural Formulation Interview, and explore physiological measures of therapeutic alliance, an important factor in psychotherapy outcomes.

Conditions

Interventions

DRUG

Psilocybin 25mg

Psilocybin 25mg

OTHER

Music-centered psilocybin-assisted therapy

Psilocybin therapy emphasizing the use of music.

OTHER

Mindfulness-centered psilocybin-assisted therapy

Psilocybin therapy emphasizing the use of guided mindfulness.

Sponsors & Collaborators

  • Kyle Greenway

    lead OTHER

Principal Investigators

  • Kyle T Greenway, MD · Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-07-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373535 on ClinicalTrials.gov