Abstract Despite growing interest in psychedelic-assisted psychotherapy, research investigating the psychotherapeutic components is lacking. This leaves unanswered questions regarding the psychotherapy's necessity and form. This observational study addresses this gap by measuring the outcomes of a psilocybin truffle retreat, followed by the outcomes of two p...
To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer. Primary Objective To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for participants with depression and/or anxiety who are being actively...
Floatation-REST (Reduced Environmental Stimulation Therapy) systematically alters sensory and bodily input by combining neutral buoyancy, thermal and proprioceptive neutrality, attenuation of exteroceptive stimulation, and enhancement of cardiorespiratory signaling to the brain. Here we examined whether this non-pharmacological sensory perturbation induces a...
Abstract Background Prolonged grief disorder (PGD) is a clinically distinguishable bereavement-related condition characterized by persistent yearning, identity disruption, and impaired functioning, formalized in DSM-5-TR and ICD-11 (6L72) and empirically distinguishable from but frequently co-occurring with major depressive disorder. Approximately 7 to 10 pe...
INTRODUCTION: Psilocybin shows promise for treatment-resistant depression (TRD), but long-term data are limited. This study examined the antidepressant effect of one or two psilocybin doses with adjunct psychotherapy in TRD until twelve months. METHODS: This is a naturalistic follow-up of a phase 2b, randomized, active placebo-controlled trial, where partici...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, f...
Major depressive disorder (MDD) affects millions of Americans and remains difficult to treat. Psilocybin, a psychedelic compound, has shown promise for reducing depression symptoms, but a key challenge in psychedelic research is that participants can usually tell whether they received the active drug - making it hard to conduct fully blinded studies. This st...
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinic...
This systematic review and meta-analysis synthesized data from 13 clinical trials (n=606) evaluating psilocybin-assisted psychotherapy for major depressive disorder and treatment-resistant depression. Despite early enthusiasm, the pooled standardized mean difference (-0.79, 95% confidence interval: -3.98 to 2.40, p=0.63) revealed no statistically significant...
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized ps...
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people ...
Abstract Lyme disease, caused by the bacterium Borrelia burgdorferi, is the most common vector-borne disease in the United States and Europe. Although antibiotics effectively treat most cases, an estimated 10-20% of patients develop post-treatment Lyme disease (PTLD), a chronic syndrome marked by fatigue, pain, cognitive difficulties, mood disturbance, and r...
Background: Psilocybin is a promising therapy for cancer-related distress, but existing individual treatment models are resource intensive. In this study, we designed and tested a group model of psilocybin therapy for people with metastatic cancer and cancer-related anxiety and depression. Method: Eligibility criteria included metastatic cancer, moderate-to-...
Floatation-REST (Reduced Environmental Stimulation Therapy) systematically alters sensory and bodily input by combining neutral buoyancy, thermal and proprioceptive neutrality, attenuation of exteroceptive stimulation, and enhancement of cardiorespiratory signaling to the brain. Here we examined whether this non-pharmacological sensory perturbation induces a...
OBJECTIVE: The goals of this study were to examine the therapeutic effects and safety of psilocybin given as a pulsed regimen for the prevention of migraine and to consider the blinding integrity of an active control agent. BACKGROUND: The administration of a single low dose of psilocybin was observed to have lasting therapeutic effects in one small pilot tr...
Personality disorders (PDs) are characterized by rigid and maladaptive patterns of self- and interpersonal functioning, leading to high clinical burden and limited treatment outcomes. Schema Therapy (ST), an integrative psychotherapy rooted in cognitive-behavioral principles, conceptualizes PDs in terms of Early Maladaptive Schemas (EMS)-pervasive cognitive-...
Abstract Substance use disorders (SUDs) are increasingly common in the United States, and while this may be a dilemma for those using, it also inflicts problems for those around the user. In couples where drug abuse is present, negative codependent characteristics can arise independently in the non-user, having a damaging effect on the couple dynamic. This i...
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. This will be a phase II 2x2 design (device and dose) clinical trial. 100 participant...
Adolescent depression is a significant public health concern, yet treatment options remain limited, particularly due to age- and sex-related differences in antidepressant efficacy. This study explored for the first time the potential antidepressant-like response of psilocybin in adolescence by examining acute, repeated and persistent effects in Sprague-Dawle...
Supplement 1. Additional tables presenting primary and secondary outcomes, sensitivity analyses, and exploratory findings. Table A1. ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table A2. Adjusted ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table B1. Intent-To-Treat (ITT) Analysis for Demoralization Scale (DSII) and PTSD Checklist for DSM-5 (PCL-5). Table B2....
