Phase II Study of Psilocybin-Assisted PEARL Therapy for Caregivers of Patients with Advanced Cancer to Reduce Caregiver Distress

What this Trial Is About

Caregivers of patients with advanced cancer often face high levels of distress including depression, anxiety, anticipatory grief, spiritual suffering, caregiving burden, and reduced quality of life. This trial evaluates Psilocybin-assisted Existential, Attachment and RelationaL PEARL therapy, which combines psilocybin-assisted psychotherapy with existential, attachment, and relational approaches to address these challenges. The phase II open-label study aims to assess the feasibility, acceptability, and safety of this therapy for these caregivers. Participants will receive a single high dose of 25 mg psilocybin taken orally as part of PEARL therapy. The therapy includes preparatory sessions before the psilocybin dose, the dosing session itself, and integration sessions afterward. This approach incorporates manualized psychotherapies tailored for patients and families dealing with advanced cancer. The study is designed as a single-group intervention without placebo or comparator arms. Throughout the study, caregivers will complete the PEARL therapy protocol, including interviews and assessments to measure anxiety, depression, anticipatory grief, caregiving burden, spiritual well-being, and quality of life. Safety and adherence to the therapy will also be monitored. The study duration spans 30 months to evaluate recruitment, retention, therapy acceptability, and potential benefits. Participants will be supported throughout the process and assessed regularly for psychological and physical health.

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer