Treatment Resistant Depression Intervention with Psilocybin-assisted Psychotherapy
Investigating the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression.
St. Vincent's Hospital, Sydney
20 participants
May 22, 2024
Interventional
Conditions
Summary
This is a single centre, single arm study primarily examining the the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression patients who are on concurrent psychotropic medication.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Psilocybin-assisted psychotherapy consisting of pre psilocybin psychotherapy session/s (preparation), a psilocybin dosing day and post dosing psychotherapy sessions/s (integration). The initial dose of psilocybin to be administered to all participants will be a 15 mg oral capsule. Study clinicians will assess safety and tolerability post each dosing and only eligible participants will receive a subsequent dose/s (ranging from min 15 mg to maximum 45 mg psilocybin). Minimum number of dosing sessions during the study participation is 1 and maximum 5. Time between all dosing sessions will be at least one week. All dosing sessions will be supervised by a dyad of trained therapists for approximately 7-8 hours. The psychotherapy sessions prior to dosing (preparation) and post dosing (integration) will occur face to face. The first dosing session is preceded by three preparation sessions and proceeded by two therapy sessions, each of 1 hour duration. Preparation session/s will involve: building therapeutic alliance, psychological and practical preparation for dosing sessions, non-avoidance training, nature of and relationship to distress and anxiety management strategies, intention setting and planning for continuity of care. Dosing session/s will involve: Delivery of psilocybin dose in the presence of a therapy dyad and non-directive supervision for 8 hours in the context of a safe and comfortable environment and a curated music playlist. Integration session/s will involve: Assisting the participant in the formation of a narrative of the psychedelic experience, promoting meaning-centred integration of this narrative into the participants experience, encouraging and motivating behaviour change as a result of the above, encouraging ongoing engagement with emotional and somatic experiences and planning for ongoing support and return to usual care.
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ACTRN12623000832673