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Post-traumatic stress disorder (PTSD) and associated trauma and stressor-related disorders are common and debilitating, presenting significant treatment challenges due to their complex interplay of biological, cognitive, affective, somatic and social factors. Current treatments, while advancing and effective, yield limited efficacy for many individuals, underscoring the need for novel therapeutic approaches. This review explores the multifaceted nature of PTSD, emphasising its intricate predisposing and maintaining factors and explores the potential of psilocybin, a classical psychedelic, as a therapeutic agent. This review synthesises recent literature on the safety, efficacy and proposed mechanisms of action and change of psychedelic therapies for psychiatric conditions associated with traumatic stress, including treatment-resistant depression, end-of-life anxiety and anorexia nervosa. Correspondingly, it proposes a conceptual framework for psilocybin treatment in PTSD, framing the condition as a complex, maladaptive interpretive framework that is both predetermined and over-determined. A clinical narrative illustrates how psilocybin’s unique psychopharmacological properties and catalysed subjective effects may facilitate therapeutic progress by disrupting this rigid and restricting framework. Finally, we offer recommendations for the safe administration of psilocybin for traumatised patients in medical research settings, emphasising the importance of rigorous and trauma-informed protocols and comprehensive patient care.

Background: Physical touch is often included as a supportive or therapeutic tool in psychedelic-assisted therapy (PAT), involving instrumental forms of physical contact, supportive touch and somatic techniques. However, participants under the influence of psychedelics have reduced capacity to provide consent, are more suggestible and may experience and interpret therapeutic touch in ways they did not expect prior to taking the drug. Yet little research has been conducted on the considerations and approaches to therapeutic touch in clinical trials of PAT. Objectives: This study explored the experiences and perspectives of PAT researchers on the use and consent to therapeutic touch in clinical trials of PAT. Design: A qualitative study using semi-structured interviews. Methods: Sixteen PAT researchers involved in clinical trials of PAT were interviewed. Reflexive thematic analysis was used to analyse the data. The reporting of this study conforms to the Consolidated Criteria for Reporting Qualitative Research Checklist (COREQ). Results: Three themes were uncovered through reflexive thematic analysis: (1) flexible frameworks, (2) therapeutic alliance and (3) boundary management. Researchers discussed consent challenges across the broad spectrum of physical contact existing in PAT protocols at the time. Researchers indicated that consent to therapeutic touch should be established prior to the dosing sessions and continually managed throughout the course of treatment. Flexibility in consent protocols enabled researchers to interpret and approach consent through the development of a strong therapeutic alliance; however, flexibility could also lead to challenges in boundary management. Researchers emphasised the need for greater ethical guidance in instances where trial participants change their established preferences during dosing sessions, and limits on expanding consent after drug administration. Conclusion: Clear guidelines for obtaining consent, managing changing preferences and training on the management of boundary transgressions were viewed as essential for ethical research and practice of PAT. Plain language summary The ethical use of therapeutic touch in psychedelic-assisted therapy There is a growing body of research studying how mind-altering drugs, when used with therapy, may help treat mental health conditions. This type of therapy is called psychedelic-assisted therapy (PAT). During “dosing” sessions, participants take a carefully controlled psychedelic drug while receiving support from therapists. Therapists sometimes use touch, such as holding hands or reassuring support, to provide therapeutic care. Participants must consent to specific forms of touch prior to treatment. Why This Research Matters Getting consent for touch in PAT requires special attention because: - Psychedelic drugs change how people think and understand information - People might experience touch differently than expected while under drug effects - Participants are more vulnerable and easily influenced There are no clear guidelines for consenting participants to touch during these studies. We interviewed 16 researchers involved with PAT trials to learn about their views on obtaining and managing consent for therapeutic touch throughout treatment. Key Findings - Building trust between therapists and participants is very important for consent - Agreeing to touch is not a one-time event. It requires ongoing discussion - Therapists need better guidance about what to do when drug-affected participants change their minds about touch Our research shows that clear guidelines are essential. Research teams could benefit from incorporating our recommendations for: - Managing situations when participants change their minds about touch - Safe, ongoing communication about touch throughout treatment - Managing clear boundaries between therapists and participants Implications As clinical trials of PAT expand, our findings provide a framework to inform the development of guidelines to ensure the highest level of participant safety, ethical care, and clear professional standards.

Psychedelic-assisted therapy (PAT) has typically been evaluated using conventional randomised controlled trials (RCTs), which assess treatment efficacy under highly controlled conditions. However, PAT constitutes a complex intervention, integrating pharmacological, psychotherapeutic and contextual elements that interact dynamically with patient experiences and healthcare settings. Conventional RCTs, designed for simple interventions, may fail to capture these complexities. Pragmatic trials, by contrast, evaluate interventions under real-world conditions, assessing their effectiveness across diverse clinical environments and patient populations. This position paper advocates for the application of the UK Medical Research Council’s (MRC) framework for complex interventions to the development and evaluation of PAT. This framework emphasises the necessity of articulating the underlying theory of therapeutic change, structuring intervention development into defined phases, accounting for contextual interactions and incorporating stakeholder perspectives throughout the research process. We argue that employing pragmatic trial designs, guided by the PRECIS-2 tool, will better align PAT research with the practicalities of healthcare delivery and facilitate the translation of research findings into clinical practice. Further, we address the philosophical divergence in the field between conceptualising PAT as primarily pharmacological versus psychotherapy-augmented, noting the implications of these positions for trial design and interpretation. We propose the integration of qualitative methodologies, adaptive trial designs and comparative effectiveness research to refine PAT interventions and address limitations inherent in conventional double-blind RCT approaches. Finally, we advocate for a pluralistic evidentiary model, combining academic and community-led research, to support the rigorous, equitable and sustainable development of psychedelic-assisted therapies and to avoid the historical setbacks that previously hindered progress in this field.

RationalePsychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.ObjectiveIn this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research.ResultsAlthough some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants’ expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies are discussed in the context of study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy.ConclusionIncorporating the recommended design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increases the ability to discern treatment-specific effects of psychedelic therapy.

The growing interest in psychedelic-assisted therapy (PAT) for treating psychiatric disorders such as treatment-resistant depression, PTSD, and anxiety has led to an increasing demand for specialized training. In Switzerland, MDMA, psilocybin, and LSD are applied in the framework of limited medical use as exceptional treatment options since 2014. The Swiss Medical Association for Psychedelic Therapy (SÄPT) has been a key player in addressing the need for education, offering a comprehensive, three-year training program for physicians and psychologists. This curriculum integrates theoretical knowledge with hands-on experience, emphasizing the therapeutic relationship, ethical considerations, and the management of altered states of consciousness induced by psychedelics. This article gives an overview of the structure and framework of the training and addresses topics covered by the program through theoretical teaching and retreats focusing on practical learning. However, the demand for these programs far exceeds supply. This gap is expected to widen as psychedelics potentially become regulated prescription medications. In response, several organizations have expanded their educational offerings, including further education trainings, workshops, conferences, and symposia. Overall, there is a need for more comprehensive and accessible training programs to meet the growing demand. The evolving landscape of psychedelic research, regulatory changes, and diverse patient populations require flexible and adaptive training models. As the field progresses, it is essential to establish certification standards and ensure the continued quality of training programs to ensure the safe and effective use of PAT in clinical trials and practice.

Peer Support Workers (PSWs) in mental health and substance use treatment draw on their lived experience (LE) to support clients through mutual understanding and trust. Psychedelic-assisted therapy (PAT) is emerging as a mental health and substance use treatment modality. As interest grows, understanding PSWs' perspectives on PAT is critical to inform safe and effective implementation, and the potential role PSWs can play in models of care. This study examined factors shaping PSWs' perspectives toward PAT and perceived barriers to its adoption and implementation. A mixed methods design was employed. A cross-sectional survey informed by the Theoretical Domains Framework (TDF) captured PSWs' perceptions of PAT and potential barriers to its use. This was followed by semi-structured interviews with five survey participants. Interview transcripts were analyzed to provide a qualitative description and identify topics and patterns to enrich and contextualize the survey findings. Survey responses indicated strong PSW support for PAT, with most participants expressing willingness to recommend it to clients. Qualitative findings expanded on this interest, highlighting concerns around client safety, psychoeducation, stigma, and accessibility. The qualitative description of interview results identified key influences on PSWs' attitudes toward PAT, complementing survey results and aligning with existing literature.

Rationale Recent studies have supported the safety and efficacy of psychedelic therapy for mood disorders and addiction. Music is considered an important component in the treatment model, but little empirical research has been done to examine the magnitude and nature of its therapeutic role. Objectives The present study assessed the influence of music on the acute experience and clinical outcomes of psychedelic therapy. Methods Semi-structured interviews inquired about the different ways in which music influenced the experience of 19 patients undergoing psychedelic therapy with psilocybin for treatment-resistant depression. Interpretative phenomenological analysis was applied to the interview data to identify salient themes. In addition, ratings were given for each patient for the extent to which they expressed “liking,” “resonance” (the music being experienced as “harmonious” with the emotional state of the listener), and “openness” (acceptance of the music-evoked experience). Results Analyses of the interviews revealed that the music had both “welcome” and “unwelcome” influences on patients’ subjective experiences. Welcome influences included the evocation of personally meaningful and therapeutically useful emotion and mental imagery, a sense of guidance, openness, and the promotion of calm and a sense of safety. Conversely, unwelcome influences included the evocation of unpleasant emotion and imagery, a sense of being misguided and resistance. Correlation analyses showed that patients’ experience of the music was associated with the occurrence of “mystical experiences” and “insightfulness.” Crucially, the nature of the music experience was significantly predictive of reductions in depression 1 week after psilocybin, whereas general drug intensity was not. Conclusions This study indicates that music plays a central therapeutic function in psychedelic therapy.

This study draws attention to, and provides a description of, a previously unmapped and emerging self-medication phenomenon occurring in Aotearoa New Zealand where psychedelic substances are being used in the absence of clinical supervision to address a wide range of health and wellbeing issues, partly in response to unmet mental health needs. We interviewed 34 individuals who had self-administered psychedelics with the intention of improving their health or wellbeing and used thematic analysis to generate themes from the interview data that capture the salient characteristics of this practice. We found that psychedelic substances are being used in Aotearoa New Zealand to address a variety of health and wellbeing concerns, often after other treatment options have been exhausted. Those we spoke to described personalised strategies of using psychedelics which were intended to enhance efficacy and reduce the likelihood of adverse outcomes. Positive results, including symptom remission across a range of clinical disorders and general improvements to psychological wellbeing, were alleged. We highlight concerns this phenomenon raises for clinical practice, offer suggestions for reducing potential harms associated with it, and draw attention to aspects of naturalistic use that future clinical trials might consider exploring more systematically.

Purpose Depression affects around 280 million people worldwide, and about 30% of patients have treatment‐resistant depression. Ketamine has significant scientific evidence supporting its use as an antidepressant, making it a promising approach for treatment‐resistant cases. Combining ketamine with psychotherapy may enhance therapeutic response and support longer‐lasting cognitive and behavioral change. This pilot proof‐of‐concept study aims to evaluate the effect of treatment with ketamine infusion combined with psychological intervention in a sample of nine patients with treatment‐resistant depression at a general hospital within the Portuguese National Health Service. Methods Clinical outcomes were measured through the clinical interview and the patient health questionnaire (PHQ‐9) to assess complete or partial improvement. Results Following eight weeks of treatment, all showed a reduction in their PHQ‐9 scores, with the median score transitioning from a baseline categorization of “severe” depression to a “moderate” level. It was found that 44.4% (4/9) of participants showed a response to treatment (≥ 50% reduction in the PHQ‐9 score). Among the patients with suicidal ideation, slightly over half showed remission of these thoughts at the end of treatment. Among the participants subsequently monitored as outpatients, only 29% (2/7) experienced a deterioration in mood within three months post‐treatment, requiring an adjustment of antidepressant therapy. Conclusion In our study, an improvement in depressive symptoms was observed, despite their severity, in a sample submitted to multiple previous pharmacological strategies.This retrospective study evaluated ketamine infusions combined with psychotherapy in nine patients with treatment‐resistant depression at a general hospital. After eight weeks, all participants improved, with PHQ‐9 scores shifting from severe to moderate. Overall, 44% responded to treatment, and among those with suicidal ideation, more than half showed remission. This retrospective study evaluated ketamine infusions combined with psychotherapy in nine patients with treatment‐resistant depression at a general hospital. After eight weeks, all participants improved, with PHQ‐9 scores shifting from severe to moderate. Overall, 44% responded to treatment, and among those with suicidal ideation, more than half showed remission.

Recent research offers good reason to think that various psychedelic drugs—including psilocybin, ayahuasca, ketamine, MDMA, and LSD—may have significant therapeutic potential in the treatment of various mental health conditions, including post-traumatic stress disorder, depression, existential distress, and addiction. Although the use of psychoactive drugs, such as Diazepam or Ritalin, is well established, psychedelics arguably represent a therapeutic step change. As experiential therapies, their value would seem to lie in the subjective experiences they induce. As it is the only way for trainee psychedelic therapists to fully understand their subjective effects, some have suggested that firsthand experience of psychedelics should form part of training programs. We question this notion. First, we consider whether the epistemic benefits offered by drug-induced psychedelic experience are as unique as is supposed. We then reflect on the value it might have in regard to the training of psychedelic therapists. We conclude that, absent stronger evidence of the contribution drug-induced experiences make to the training of psychedelic therapists, requiring trainees to take psychedelic drugs does not seem ethically legitimate. However, given the potential for epistemic benefit cannot be entirely ruled out, permitting trainees who wish to gain first-hand experience of psychedelics may be permissible.