Understanding Music and Mindfulness Preferences in Psilocybin-Assisted Psychotherapy

Enrollment Feasibility

The proportion of participants screened as eligible who enroll in the trial.

Overall Trial Completion Feasibility

The proportion of enrolled participants who complete the trial, defined as attending ≥ 90% of required study visits.

Trial Completion by Preference Assignment

The proportion of participants in the preferred and non-preferred treatment groups who complete ≥ 90% of study visits.

Distribution of Treatment Preferences

The proportion of participants who choose the music-centered versus the mindfulness-centered approach as their preferred treatment at baseline.

Rate of Adverse Events in Music- versus Mindfulness-centered Interventions

Rates of adverse events in participants receiving music-centered versus mindfulness-centered approaches. Adverse events include any treatment-emergent symptoms reported by participants or observed by study staff.

Rate of Adverse Events in Preferred vs. Non-Preferred Interventions

Rates of adverse events in participants receiving their preferred versus non-preferred interventions. Adverse events include any treatment-emergent symptoms reported by participants or observed by study staff.

Rate of Participant Drop-Outs in Preferred vs. Non-Preferred Interventions

Rates of participant drop-outs in participants receiving their preferred versus non-preferred interventions. Drop-out is defined as missing more than 10% of scheduled visits during the active treatment period.

Rate of Participant Drop-Outs in Music- versus Mindfulness-centered Interventions

Rates of participant drop-outs in participants receiving music-centered versus mindfulness-centered approaches. Drop-out is defined as missing more than 10% of scheduled visits during the active treatment period.

Therapeutic Alliance - Patient (WAI-SR)

The Working Alliance Inventory - Short Revised (WAI-SR, Patient version) is a 12-item, self-reported measure assessing patients' perception of the therapeutic alliance during treatment sessions. Items assess agreement, collaboration, and bond with the therapist, including understanding goals, agreement on tasks, mutual respect, and perceived care and support. Participants rate each item on a 5-point Likert scale ranging from 1 (seldom) to 5 (always). Total scores are calculated by summing item responses, with possible scores ranging from 12 to 60. Higher scores indicate a stronger therapeutic alliance. Scores will be compared by preference group (preferred vs. non-preferred) and therapeutic approaches (music-centered versus mindfulness-centered).

Therapeutic Alliance - Therapist (WAI-SRT)

The Working Alliance Inventory - Short Revised (WAI-SR, Therapist version) is a 10-item, self-reported measure assessing therapists' perception of the therapeutic alliance during treatment sessions. Items evaluate agreement on goals and tasks, mutual understanding, collaboration, respect, and concern for the patient's welfare. Therapists rate each item on a 5-point Likert scale ranging from 1 (seldom) to 5 (always). Total scores are calculated by summing item responses, with possible scores ranging from 10 to 50. Higher scores indicate a stronger perceived therapeutic alliance. Scores will be compared by preference group (preferred vs. non-preferred) and therapeutic approaches (music-centered versus mindfulness-centered).

Linguistic Synchrony

Linguistic synchrony between the participant and clinicians will be quantified using Natural Language Processing (NLP) applied to session transcripts. The measure has no predefined minimum or maximum value; higher values indicate greater alignment in language use between the participant and clinicians. Scores will be compared by preference group (preferred vs. non-preferred) and therapeutic approaches (music-centered versus mindfulness-centered).

Cardiovascular Synchrony

Cardiovascular synchrony between the participant and clinicians will be assessed using electrocardiography (ECG)-derived heart rate variability (HRV) and respiratory sinus arrhythmia (RSA). A validated surrogate synchrony method will be applied to quantify the extent of physiological alignment between the participant and clinicians during therapy sessions. The measure has no predefined minimum or maximum value; higher values indicate greater cardiovascular synchrony. Scores will be compared by preference group (preferred vs. non-preferred) and therapeutic approaches (music-centered versus mindfulness-centered).