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Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial1.40 MB
Published (Version of record)CC BY-NC V4.0, Open Access
Published (Version of record)CC BY-NC V4.0, Open
Journal article
Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial: protocol for an open-label pilot trial for cancer-related bereavement
BMJ open, Vol.15(4), pp.1-12
15/04/2025
PMID: 40233965
Appears in Recent Faculty of Health Publications
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Abstract
Introduction: Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial is the first study to consider psilocybin-assisted psychotherapy as a potential treatment for prolonged grief.
Methods and analysis: PARTING is an open-label pilot trial of psilocybin-assisted psychotherapy for approximately 15 people with cancer-related PGD. It aims to investigate feasibility, safety, acceptability, participant experience and participant-reported therapeutic effects. Over a 5-week intervention period, participants will undergo three preparation sessions before receiving a psychoactive (25 mg) dose of psilocybin alongside non-directive supportive guidance, followed by four integration sessions. All sessions will be delivered by a psychologist and either a nurse or Indigenous Therapist. An artificial intelligence-assisted tool will be used to create an artwork of participants’ psychedelic experience. Outcomes will be investigated over a 12-month follow-up period. Feasibility will be assessed through recruitment/retention rates and completion of follow-up assessments. Safety will be evaluated via adverse events over 12 months and the comparison of physiological measures (vital signs, biochemistry, haematology, ECG) recorded during screening and 1 day after the psilocybin dose. Qualitative thematic analysis of semistructured interviews with participants and trial therapists will assess acceptability and the therapeutic potential of the treatment. Diagnostic clinical interviews for PGD and quantitative participant-reported measures of therapeutic effects are also being collected. Participant-reported measures include grief severity, depression, anxiety, grief avoidance, psychological flexibility, connectedness, and quality of life.
Ethics and dissemination: Ethics approval has been obtained from QIMR Berghofer Medical Research Institute Human Research Ethics Committee (P3801). Dissemination of results will occur via conference presentations, peer-reviewed publications and media.
Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12623000827639).
Details
- Title
- Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial: protocol for an open-label pilot trial for cancer-related bereavement
- Creators
- Vanessa L Beesley - QIMR Berghofer Medical Research InstituteTom J Kennedy - QIMR Berghofer Medical Research InstituteFiona Maccallum - University of QueenslandMargaret Ross - St Vincent's HospitalRenee Harvey - Enosis TherapeuticsSusan L Rossell - St Vincent's HospitalJerome Sarris - Swinburne University of TechnologyDaniel Perkins - Swinburne University of TechnologyRachel E Neale - QIMR Berghofer Medical Research InstituteJames Bennett-Levy - QIMR Berghofer Medical Research InstituteShevaugn Johnson - QIMR Berghofer Medical Research InstituteHanna Beebe - QIMR Berghofer Medical Research InstituteNatalie Roset - QIMR Berghofer Medical Research InstituteJörg Strobel - Consumer RepresentativeStephen Parker - QIMR Berghofer Medical Research Institute
- Publication Details
- BMJ open, Vol.15(4), pp.1-12
- Publisher
- British Medical Journal Publishing Group; LONDON
- Grant note
- This work is funded by a QIMR Berghofer Medical Research Institute Seed Grant and an allocation from the QIMR Berghofer Psychedelic Medicine and Supportive Care Lab.
- Identifiers
- 991013276600002368
- Copyright
- © Author(s) (or their employer(s)) 2025
- Academic Unit
- Faculty of Health
- Language
- English
- Resource Type
- Journal article