PARTING: Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief
This single-arm, open-label trial (n=15) assesses feasibility, acceptability and safety of psilocybin-assisted supportive psychotherapy (single 25 mg oral psilocybin session) for prolonged grief disorder in bereaved cancer carers.
Details
Single-group, open-label Phase I feasibility study delivering manualised supportive psychotherapy around a single 25 mg oral psilocybin dosing session to bereaved carers with prolonged grief disorder; psychotherapy includes three preparatory sessions and four integration sessions delivered by a lead clinical psychologist and an assistant therapist with psychiatrist oversight.
Primary outcomes are feasibility metrics (recruitment, retention, and fidelity) measured via REDCap logs and session recordings; clinical measures of grief (PG-13-Revised) and other follow-up questionnaires are assessed at baseline, 1 day, 6 weeks, 12 weeks, 6 months and 12 months post dosing.