PARTING: Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief; a phase II feasibility safety trial
PARTING: Assessing the feasibility, acceptability and safety of Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief in bereaved cancer carers.
QIMR Berghofer Medical Research Institute
15 participants
May 27, 2024
Interventional
Conditions
Summary
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 assistant therapist 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.
Eligibility
Inclusion Criteria10
- Adult bereaved carer of a patient who died from cancer more than 12 months ago
- Meets the threshold for prolonged grief disorder as measured on the validated Prolonged Grief Disorder Scale (PG-13-Revised) and in a clinical interview.
- Under the care of a psychiatrist, psychologist, physician, or general practitioner
- Proficient in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires
- Living in Brisbane QLD or able to travel to Brisbane for the in-person intervention sessions
- Intention to complete all 8 intervention sessions
- Agree to have their drug dosing sessions recorded to video for treatment fidelity and clinical supervision.
- Able to swallow pills.
- Treating medical doctor can confirm patient has safely tapered and washed-out current antidepressant pharmacotherapy prior to baseline assessment.
- Agree to be abstinent from illicit drugs or medications outside of your usual and allowed prescribed medications and alcohol use for at least 2 days prior to psilocybin dosing.
Exclusion Criteria18
- Disorder with known central nervous system involvement
- In treatment in another clinical trial involving an investigational product
- Hepatic dysfunction
- Hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
- Cardiovascular conditions
- Currently on preventative medication for migraines
- Epilepsy
- Positive pregnancy test or trying to get pregnant
- Current hypothyroidism or hyperthyroidism as identified by blood test
- Weight less than 40 kg or has a body mass index <15.
- Use of any hallucinogen or psychedelic drug within the past 12 months
- Any significant adverse events after prior use of any hallucinogen or psychedelic
- Medications that may have interactions with psilocybin
- Diagnosed psychotic disorder or severe post-traumatic stress disorder
- First-degree family member with a diagnosed psychotic disorder
- History of suicide attempts or mania
- Moderate-severe drug or alcohol dependence
- Are unable to give adequate informed consent
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Interventions
This psilocybin-assisted psychotherapy intervention involves a combination of pharmacological and psychological treatment. All participants will receive three psychotherapy sessions anticipated to take 1.5 hours each, 1, 2 and 3 days before the 8-hour psilocybin dosing session, then four psychotherapy sessions anticipated to take 1.5 hours, 1 day, then 1, 2 and 4 weeks after the dosing session. The psychotherapy focuses on three distinct phases: (1) Preparation: emphasizing therapeutic alliance, non-avoidance training, psychological and practical preparation for dosing sessions, nature of and relationship to distress, anxiety management strategies, the importance of set and setting, and intention formation; (2) Dosing session: establishing suitable set and setting, non-directive support; (3) Integration: processing what came up in the psilocybin session including any memories of the death and loss (i.e. blocks) and rebuilding by teaching specific strategies in cognitive restructuring to reframe common maladaptive grief-related appraisals (e.g. hopelessness and guilt), communication with the deceased to manage unfinished business and goal setting and/or reintegration into a life that they actually want to live (i.e. beginning the process of making changes to their life following the experience and consider how these may be continued and expanded. The final session will include referral pathways for post-care). The investigational product (Psilocybin Trihydrate [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate) will be provided by Cortexa and the dose of the psilocybin capsule used in the study is 25 mg administered orally with water. All participants will be seen by the same two therapists (a clinical psychologist and assistant therapist) in all the psychotherapy sessions and during the psilocybin session. A trial psychiatrist will oversee baseline medical assessments on dose day and be present in the building during the duration of the psilocybin dosing session in case medication and management of any severe adverse events is required. The trial psychologists and assistant therapists are qualified and experienced mental health professionals. The trial therapists, psychiatrist and the lead investigator have undergone professional development training in psilocybin-assisted therapy and prolonged grief therapy order to facilitate this treatment approach safely and successfully. The intervention is supported by a therapy manual developed by the investigator team who are leading experts in psilocybin-assisted psychotherapy and prolonged grief therapy. Moreover, all clinicians on the trial will meet with CI Renee Harvey for ongoing clinical supervision. Descriptive statistics assessing feasibility will include: (i) recruitment rate (enrolled/invited participants); (ii) retention rate (completed seven sessions/enrolled participants); (ii) fidelity to five follow-up questionnaires at 1 day, 6 weeks, 12 weeks, 6 months and 12 months post dosing day (questionnaires completed/active participants). Should participants consent, treatment fidelity will also be monitored via video recordings of all intervention phases. Finally, REDCap session logs will also monitor fidelity to the manualized intervention.
Locations(1)
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ACTRN12623000827639