Psilocybin Assisted-Cognitive Processing Therapy for Chronic Post-Traumatic Stress Disorder
pending REB amendment
Overview
Psilocybin, a naturally occurring psychedelic compound, has shown potential to enhance emotional processing and facilitate profound shifts in perspective. Psilocybin-assisted cognitive processing therapy offers a promising approach for individuals suffering from chronic Post-Traumatic Stress Disorder (PTSD). By integrating the therapeutic benefits of cognitive processing therapy with the potential healing properties of psilocybin, this innovative treatment aims to provide a comprehensive and holistic path to recovery. When combined with the structured framework of cognitive processing therapy, which focuses on addressing maladaptive thought patterns and processing traumatic experiences, individuals may experience a more effective and transformative healing journey. This study aims to establish the feasibility,tolerability and effects of using psilocybin assisted-cognitive processing therapy in individuals with chronic posttraumatic stress disorder. In this pilot study, 15 individuals will be recruited to receive a single dose of psilocybin with cognitive processing therapy.
Inclusion Criteria
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Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer
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Between the ages of 18 and 65 (inclusive)
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Able to understand and comply with the requirements of the study, as judged by the investigator(s)
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Willing to stop prohibited medications such as antidepressants, psychostimulants, and antipsychotics
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Ownership of a smartphone
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Agree to video and audio recording of all study visits including therapy sessions and clinical assessments
Exclusion Criteria
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Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder
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Pregnant, lactating or of childbearing potential and not willing to use an approved method of contraception during the study
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Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject’s ability to complete the study or its measures.
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Do not own a smartphone
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Non-English-speaking individuals are excluded because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary
*Inclusion/exclusion criteria is not exhaustive. Lifestyle modifications such as alcohol consumption may be required as part of this study.
Treatment Description
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All participants in this study will receive a 25 mg dose of psilocybin as well as 12 cognitive processing therapy sessions and preparatory and integration sessions.
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Participants will be followed up with for 12 weeks after the intervention week.
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All participants will receive an Oura Ring which will collect passive physiological data (e.g. sleep, activity and readiness) throughout the course of the study.
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On a daily or weekly basis, participants will complete self-report questionnaires relevant to mental health and quality of life.
Interested in participating in our study? Please email psilocybin@unityhealth.to to find out if you are eligible.
Artificial Intelligence for Mental Health
Location
30 Bond Street,
Toronto, ON M5B 1W8
St. Michael’s Hospital
17th Floor, Cardinal Carter Wing
Contact Us
Email: aim@unityhealth.to
Phone: 416-864-5418
Fax (Referrals only): 416-864-5480