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Psilocybin-Assisted Cognitive Behavioral Therapy for Adults with Major Depressive Disorder: Rationale and Treatment Development

Marc J. Weintraub, Jessica K Jeffrey, Charles S. Grob, Megan Ichinose, R. Lindsey Bergman, Ziva D. Cooper, David J. Miklowitz

Psychedelic Medicine September 6, 2023 DOI: 10.1089/psymed.2023.0018 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Trial protocol Randomized Peer reviewed
Population Patients with depression and other mental health conditions
Intervention Psilocybin-assisted cognitive behavioral therapy
Topics Depression Psilocybin
Keywords Cognitive behavioral therapy Psychotherapist Cognition Cognitive therapy Clinical psychology
Citations 4
Registration NCT05227612
Key findings The trial aims to provide preliminary data on the feasibility, safety, acceptability, and psychosocial effects of psilocybin-assisted cognitive behavioral therapy for depression.

Abstract

The trial will provide preliminary data on the feasibility, safety, acceptability, and psychosocial effects of PA-CBT. Results will inform randomized clinical trials to test the effects of PA-CBT for patients with depression and other mental health conditions, as well as hypotheses concerning mediating mechanisms at the cognitive and affective levels. ClinicalTrials.gov ID: NCT05227612.

Comparable studies

Other non-randomized and open-label trials on psilocybin for depression, most cited first.

Study Year Design Participants
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Patients with moderate-to-severe, unipolar, treatment-resistant major depression 2016 Open-label feasibility trial n = 12
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression 2017 Open-label trial n = 20
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Patients with major depressive disorder 2021 Open-label study n = 24
Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression. Individuals diagnosed with moderate to severe, treatment-resistant depression 2017 Open-label study n = 20

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