PARTING: Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief

This single-arm, open-label trial (n=15) aims to assess the feasibility, acceptability, and safety of Psilocybin-Assisted Supportive Psychotherapy in treating prolonged grief disorder in bereaved cancer carers.

Conducted by the QIMR Berghofer Medical Research Institute in Australia, the study involves three psychotherapy sessions before a psilocybin dosing session and four post-experience integration sessions.

Participants will be closely monitored by trial psychologists and nurses. Rigorous screening will be conducted to ensure eligibility, and baseline and follow-up assessments will measure prolonged grief symptoms. Feasibility, acceptability, and safety will be evaluated through recruitment and retention rates, fidelity to assessments, and adverse event monitoring.

The trial aims to provide an initial impression of efficacy through qualitative analysis of participants’ experiences and changes in grief scores.

The intervention, supported by Woke Pharmaceuticals, involves administering 25 mg of psilocybin orally. Recruitment started on 13th November 2023, with an anticipated completion date of 22nd April 2024.

Trial Details

While grief is a normal reaction to loss, 30% of cancer carers are reported to experience prolonged grief disorder. Patients with prolonged grief require grief-focused intervention in addition to the depression-focused treatment. Psilocybin-assisted psychotherapy is an experimental intervention that could reduce grief-related distress and suffering. PARTING is a single-arm (open-label) study of a psilocybin-assisted psychotherapy trial. This study aims to determine whether this new treatment is acceptable to and safe for participants and to establish an initial impression of its effectiveness in treating people with prolonged grief. It will include approximately 15 participants. Bereaved carers of people with cancer who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for prolonged grief disorder will be invited to take part in PARTING. Potential participants will undergo rigorous screening before enrolment to meet general medicine and psychiatric eligibility criteria. The intervention will include three psychotherapy sessions in preparation for one psilocybin dosing session and then four post-experience psychotherapy integration sessions. All participants’ sessions will involve a trial psychologist and a trial nurse being present. Baseline and follow-up survey and clinical assessments will measure prolonged grief symptoms i.e. the outcome for the future full-scale trial. Following participants’ final intervention session, participants will complete a semi-structured evaluation interview about their experience. Responses will be transcribed and qualitatively analysed using thematic analysis. The 15 evaluation interviews with participants will provide information about intervention acceptability and a qualitative initial impression of efficacy and will be used to refine the intervention. As a secondary analysis of potential efficacy we will also explore changes in grief scores. We postulate that the treatment will be well tolerated and accepted and grief symptoms will be substantially reduced.

Trial Number ACTRN12623000827639

Data attribution

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