A pilot TriAl of psilocybiN-Assisted psychotherapy for the treatment Of Sex addiction

Sex addiction

Protocol completion rate, defined as the proportion of randomised participants who completed all scheduled visits and procedures, including all PAP sessions, control sessions and follow-up assessments, until the end of their participation in the study

Recruitment feasibility will be considered validated if the target of recruiting 30 participants within the planned enrolment period is met, as assessed using the CONSORT diagram (number of participants screened, eligible, enrolled, etc.); the proportion of participants enrolled who continue treatment to completion in each arm; and an assessment of the maintenance of blinding., The acceptability of the treatment will be assessed on the basis of self-reported acceptability by patients and carers: duration, number and frequency of sessions; reasons for eligible patients refusing to participate and for dropouts, Changes in mean scores (plus standard deviations) or proportions, in each arm, between the baseline assessment (V0) and the post-treatment assessment: - of self-efficacy (General Self-Efficacy Scale: GSES); - of the Clinical Global Impression of Severity (CGI-S); - self-compassion (Self-Compassion Scale: SCS); - spirituality (World Health Organisation Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument), Correlation between the intensity of the psychedelic experience, as measured by the post-administration MEQ-30 score, and the mean scores (+ standard deviations) or proportions at baseline of the following variables in the experimental arm: spirituality (WHOQOL-SRPB); self-compassion (SCS); treatment expectations (CEQ at baseline); self-efficacy (GSES); and the measure of blind maintenance, Mean scores (plus standard deviations) or proportions, in each arm: of heart rate (HR) and blood pressure (BP) during administration sessions; of expected acute effects (20-item behaviour and mood observation scale), assessed during administration sessions; the number, type, severity and attributable cause of adverse reactions (excluding expected acute effects), assessed during administration sessions and throughout the study; increase in suicide risk; therapeutic index and clinical improvement

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