CONTEXT Psilocybin-assisted therapy has demonstrated rapid antidepressant effects in patients with cancer, but most trials have excluded individuals receiving active systemic anticancer treatment, limiting safety data in this population. OBJECTIVES To compare the efficacy and safety of psilocybin-assisted therapy in patients receiving versus not receiving concurrent systemic anticancer...
Background: Understanding the benefits of psychedelic-assisted therapy (PAT) will require scientific attention to the causal interaction between the therapeutic context and process. Measuring what actually happens during PAT in large-scale studies will be an essential component of this work. Objective: We aim to develop and preliminarily evaluate the feasibility and reliability of a direct...
Psilocybin shows encouraging outcomes for patients with cancer and major depressive disorder (MDD). However, there is insufficient evidence on the use of evidence-based psychotherapeutic interventions to consistently guide and standardize psilocybin preparation, dosing, and integration. Meaning-centered psychotherapy (MCP) is a manualized, brief psychotherapeutic intervention that enhances...
Recent clinical trials have suggested the safety and efficacy of psychedelic therapy for treatment-resistant depression, posttraumatic stress disorder, addiction, and end-of-life distress. While neurobiological mechanisms such as 5-HT2A receptor activation, increased neural entropy, and default mode network modulation have been well-characterized, significantly less attention has been given to...
Abstract Background and aims Psychedelic-assisted therapies (PAT) have emerged as promising treatments for mental health conditions such as depression, anxiety, and trauma-related disorders. However, the underrepresentation of Black, Indigenous, and People of Color (BIPOC) in PAT research and clinical practice limits equitable access and the generalizability of outcomes. This study explored the...
Post-traumatic stress disorder (PTSD) is a debilitating condition leading to significant personal and societal burden. Standard treatments frequently demonstrate limited efficacy, leading to persistent symptoms and high dropout rates. Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD. We aimed to explore participant experiences of psilocybin...
Background: Cancer poses an existential threat for patients and caregivers. Psilocybin-assisted therapy (PAT) has emerged as a potential tool to meet these existential needs, yet little is known about how patients describe this element of their cancer journey, and how it might be affected by PAT, especially in the group therapy context. Purpose: To explore how patients with cancer and...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition for which there are few efficacious treatments. Psilocybin is being studied for use in treatment-resistant depression but has not yet been investigated in PTSD. Aims: The trial’s primary outcome was to investigate the safety and tolerability of single-dose psilocybin in participants with PTSD. Methods: This was a...
Abstract Background Patients with cancer often struggle with depression, which can negatively impact quality of life as well as be challenging to manage. Methods A phase 2 trial was conducted that demonstrated safety, feasibility, and efficacy of a single dose of psilocybin combined with psychological support in a community cancer setting in 30 patients with cancer and a major depressive...
Research has demonstrated both risks and benefits to using psychedelics as a therapeutic intervention for a variety of mental health conditions. In recent years, the public discourse around psychedelic treatments has been largely positive and focused on benefits more than risks. We believe the field would benefit from more balanced attention to the risks as well as benefits of psychedelics...
Psilocybin-assisted therapy (PAT) shows promise for cancer-related depression, yet little research has examined how therapeutic context shapes patient experiences. While set (mindset) and setting (environment) are considered central to psychedelic treatment, empirical evidence on their role in PAT acceptability remains limited. This study explores factors influencing the acceptability of PAT...
Prolonged Grief Disorder (PGD) is distinct from yet related to non-pathologic grief, depression, addiction, and Post-Traumatic Stress Disorder (PTSD) with a prevalence of up to 10% in bereaved populations. Hallmarks of PGD include functional impairment a year or more post-bereavement and intense yearning for the deceased. Current treatments for PGD are typically psychological rather than...
Abstract Background Depression is common in patients with cancer and is associated with lower treatment adherence and reduced quality of life. Antidepressants and psychotherapy have limited success in improving depression among patients with cancer. This study explored the safety, feasibility, and efficacy of psilocybin‐assisted therapy in patients with cancer and major depressive disorder....
Abstract Background The present study explored the acceptability of psilocybin‐assisted group therapy from the perspective of patients with cancer and depression who participated in a clinical trial assessing the safety and efficacy of this novel intervention. Methods Guided by the conceptual framework of acceptability, the authors conducted semi‐structured interviews with participants of the...
Objective To compare group and individual psychedelic-assisted therapy in terms of clinician time, costs and patient access. Methods Using 2023 data from two group therapy trial sites, one using 3,4-Methylenedioxymethamphetamine (MDMA) to treat posttraumatic stress disorder (PTSD), and one using psilocybin to treat major depressive disorder (MDD), we compared overall variable costs, clinician...
Context: Measuring therapeutic connection during psilocybin-assisted therapy is essential to understand underlying mechanisms, inform training, and guide quality improvement. Purpose: To evaluate the feasibility of directly observing indicators of therapeutic connection during psilocybin administration encounters. Methods: We evaluated audio and video data from a recent clinical trial for...
12021 Background: Up to 25% of people living with cancer have depression. Existing psychological interventions have limited efficacy in treating depression. Psilocybin, a 5-hydroytrptamintergic psychedelic, coupled with group therapy is safe and effective in ameliorating symptoms of depression (Agrawal et al, ASCO 2022). Response to psilocybin treatment was observed in 83.3% of patients at 8...
This nonrandomized controlled trial used a 1-to-1 therapist-to-patient ratio to administer psilocybin to groups of patients with cancer who were diagnosed with major depression disorder to create a scalable, rapidly effective depression treatment.
While psychedelics have been shown to improve psycho-spiritual well-being, the underlying elements of this change are not well-characterized. The NIH-HEALS posits that psycho-social-spiritual change occurs through the factors of Connection, Reflection & Introspection, and Trust & Acceptance. This study aimed to evaluate the changes in NIH-HEALS scores in a cancer population with major...
12097 Background: More than 17 million people in the U.S. live with cancer and up to 25% of them have major depression. Depression leads to lower treatment adherence, reduced quality of life, and higher rates of mortality in cancer. Yet, interventions used to treat depression in patients with cancer have limited success. Prior trials using psilocybin to treat anxiety and depression associated...
Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest...
Background: With support from the Radcliffe Institute for Advanced Study at Harvard University, we convened researchers representing palliative care, psychosocial oncology, spiritual care, oncology, and psychedelic-assisted therapies. We aimed to define priorities and envision an agenda for future research on psychedelic-assisted therapies in patients with serious illness. Over two days in...