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519. PSILOCYBIN ASSISTED PSYCHOTHERAPY FOR OBSESSIVE COMPULSIVE DISORDER, BODY DYSMORPHIC DISORDER, AND ANOREXIA NERVOSA: STUDY PROTOCOL

N Acevdo, David Castle, Susan L. Rossell

The International Journal of Neuropsychopharmacology August 1, 2025 DOI: 10.1093/ijnp/pyaf052.084 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open label basket design trial protocol Open-label Qualitative Peer reviewed
Intervention Psilocybin assisted psychotherapy
Topics Psilocybin Psychedelic-assisted therapy
Keywords Anorexia nervosa Body dysmorphic disorder Obsessive compulsive Psychotherapist Clinical psychology
Key findings A comprehensive trial protocol for psilocybin-assisted psychotherapy for obsessive compulsive disorder, body dysmorphic disorder, and anorexia nervosa was developed by integrating evidence from scoping reviews, expert consensus, and lived experiences.

Abstract

Abstract Background Obsessive compulsive disorder (OCD), body dysmorphic disorder (BDD), and anorexia nervosa (AN) are some of the most debilitating and chronic mental health conditions, with impairments across multiple domains of functioning, leading to poor quality of life and well-being. These conditions share overlapping psychopathological determinants in terms of cognitive-behavioural dysfunction and neurobiological underpinnings involving aberrant neurocircuitry. Conventional treatments lead to sub-optimal outcomes; often lacking an integrated approach to psychological and neurobiological determinants of the condition. There is often a lack of engagement and/or specialised interventions, leading to high treatment resistant rates. Although limited, there is theoretical and empirical support for the use of psilocybin assisted psychotherapy (PAP) in treating these conditions. Evidence from major depression trials demonstrate dramatic improvements in insights, perspectives, emotional regulation and well-being. Thus, highlighting transdiagnostic potential in patients with rigid and inflexible cognitive- affective processes. Aims & Objectives To present a protocol of PAP for OCD, BDD and AN in an open label basket design trial. The protocol is informed by existing empirical evidence (scoping reviews), expert consensus (Delphi study), and lived experiences (qualitative interviews).

Method: The following studies were conducted to collectively inform the study protocol; 1) a scoping review on the efficacy of serotonergic psychedelics for OCD, BDD, AN, 2) a scoping review on integration approaches of serotonergic psychedelics for mental disorders, 3) an international Delphi study on best practices of PAP, and 4) qualitative interviews from a PAP trial in AN.

Results: The trial involves an open label basket design with a transdiagnostic and non-directive approach for obsessive compulsive and body image disorders. The protocol incorporates a psychoeducation booklet and video to foster patient and carer education and informed consent. A treatment manual is developed to guide clinicians on a non-directive approach with psychotherapeutic techniques relevant to obsessive compulsive and disordered body image psychopathology. The protocol incorporates additional notable elements such as clinician and patient reported outcomes, opt-in additional support, and long term follow-up. Discussion & Conclusions Considering the scarcity of PAP applications in OCD, BDD and AN it is necessary to draw on all available evidence to ensure optimal approaches are adopted. An integrative and comprehensive trial design is developed through combining clinician, researcher, and patient perspectives on the best approaches for patient safety, tolerability and long-term efficacy.

Comparable studies

Other non-randomized and open-label trials on psilocybin and psychedelic-assisted therapy, most cited first.

Study Year Design Participants
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
Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Patients with major depressive disorder 2021 Open-label study n = 24
HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. Cancer patients with a DSM-5 depressive disorder (major depressive disorder or... 2023 Open-label feasibility and safety pilot study n = 12
Group psychedelic therapy: empirical estimates of cost-savings and improved access Adults with PTSD or major depressive disorder eligible for psychedelic-assisted therapy... 2023 Comparative cost analysis using trial data and published estimates
Increased low-frequency brain responses to music after psilocybin therapy for depression. Patients with treatment-resistant depression 2023 Open-label trial n = 19

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