The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.
18 years of age or older.
Participant must reside in Ontario, Canada.
Ability to speak and read English (participant to provide written informed consent and participate in PEARL intervention, as determined by study personnel).
No cognitive impairment indicated in medical record or by the primary care physician.
A history of past intolerability to psilocybin or other psychedelics.
Past/present psychiatric diagnoses of bipolar disorder, any psychotic disorder, active substance use disorders, or dementia.
Clinically significant suicidal ideation either currently or within the past 6 months, as judged by study clinicians.
Participant under the age of 30 years who has a first degree relative with a primary psychotic disorder.
Single group
Psilocybin
DrugSingle high-dose (25mg) capsule of psilocybin taken orally in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy
Recruitment feasibility as assessed by the number of caregivers who consent/number of caregivers who meet eligibility criteria.
Used to assess feasibility of PEARL therapy.
Retention feasibility as assessed by the number of caregivers completing primary endpoint measures/number of caregivers consented.
Used to assess feasibility of PEARL therapy.
Adherence feasibility as assessed by the number of caregivers completing all PEARL sessions/number of caregivers consented.
Used to assess feasibility of PEARL therapy.
Acceptability of PEARL therapy from the perspective of the caregivers of patients with advanced cancer obtained through qualitative interviews.
Participants will be interviewed regarding their experiences with PEARL, including acceptability and perceived positive and negative effects of the intervention, with a semi-structured interview guide.
Caregiver perspectives on the clinical relevance of potential PEARL therapy outcomes: Anxiety symptoms as assessed with the GAD-7.
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale used to screen for and measure anxiety symptoms. Total score range is 0 to 21. Higher scores indicate higher levels of anxiety.
Caregiver perspectives on the clinical relevance of potential PEARL therapy outcomes: Depressive symptoms as assessed with the PHQ-9.
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report scale measuring depressive symptoms. Total score range is 0 to 27. Higher scores indicate greater severity of depression.
Caregiver perspectives on the clinical relevance of potential PEARL therapy outcomes: Broad quality of life construct for family members of patients with serious illness as assessed with the QUAL-E (Fam).
The Quality of Life at the End of Life Measure - Family experience (QUAL-E (Fam)) is a 17-item measure that includes subscales assessing symptom impact, relationship with health care provider, completion, and preparation. For symptom impact, score range is 4 to 20, with higher scores reflecting greater symptom control; for the relationship with healthcare provider, score range is 1 to 5, with lower scores reflecting a better relationship with healthcare providers; for completion, score range is 1 to 5, with lower scores reflecting a greater sense of completion in their relationship with the patient; and for preparation, score range is 4 to 20, with lower scores reflecting greater sense of preparation.
Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Anticipatory grief as assessed with the AGS.
The Anticipatory Grief Scale (AGS) is a 27-item self-report measure of grief before loss in family caregivers. Total score range is 27 to 135. Higher scores indicate higher levels of anticipatory grief.
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