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Cited by 28Psychedelics and Drug StudiesPain Management and Placebo EffectPsychotherapy Techniques and Applications

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Validation of the Swiss Psychedelic Side Effects Inventory: Standardized assessment of adverse effects in studies of psychedelics and MDMA

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Calder, Abigail E., Hasler, Gregor·2024·Journal of Affective Disorders
DOI 10.1016/j.jad.2024.08.091
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Abstract

Introduction Studies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and sensitivity to context. A systematic questionnaire describing important characteristics of side effects of psychedelics and MDMA would greatly improve on previous methods. We aimed to create a standardized tool for recording clinically relevant side effects of psychedelics and MDMA, including their severity, duration, impact, and treatment-relatedness. Methods We constructed the Swiss Psychedelic Side Effects Inventory (SPSI) based on insights from previous research. It was pilot tested in 145 participants from three studies. Structured feedback from an expert panel was used to improve validity and feasibility. Results The final SPSI contains 32 side effects and standardized follow-up questions about their severity, impact, treatment-relatedness, and duration. It is compatible with any study design and can be administered as an interview or self-report at any timepoint after treatment with psychedelics or MDMA. Limitations The SPSI omits relatively unimportant side effects for brevity's sake, though space for additional symptoms is given. Future studies are needed to confirm its validity in different contexts. Conclusions Th…

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  • Adverse effects were systematically assessed after PAT sessions using a preliminary version of the Swiss Psychedelic Side Effects Inventory (SPSI).

    “Adverse effects were systematically assessed after PAT sessions using a preliminary version of the Swiss Psychedelic Side Effects Inventory (SPSI), which was developed in our clinic by GH and AEC and will be described in detail in an upcoming publication (Calder and Hasler, 2024).”

    From Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response (2024) · cites this paper as Calder and Hasler, 2024

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Research works printed but not linked: 24

  1. Allen, 2018, Eliciting adverse effects data from participants in clinical trials, Cochrane Database Syst. Rev., 1, MR000039
  2. Breeksema, 2024, Patient perspectives and experiences with psilocybin treatment for treatment-resistant depression: a qualitative study, Sci. Rep., 14, 10.1038/s41598-024-53188-9 · DOI · Paper page
  3. Bremler, 2023, Case analysis of long-term negative psychological responses to psychedelics, Sci. Rep., 13, 15998, 10.1038/s41598-023-41145-x · DOI
  4. Calder, 2023, Extrapharmacological safety topics in psychedelic-assisted psychotherapy, JAMA Psychiatry, 80, 761, 10.1001/jamapsychiatry.2023.1031 · DOI
  5. Carbonaro, 2016, Survey study of challenging experiences after ingesting psilocybin mushrooms: acute and enduring positive and negative consequences, J. Psychopharmacol., 30, 1268, 10.1177/0269881116662634 · DOI
  6. Colcott, 2024, Side-effects of MDMA-assisted psychotherapy: a systematic review and meta-analysis, Neuropsychopharmacology, 10.1038/s41386-024-01865-8 · DOI
  7. Evans, 2023, Extended difficulties following the use of psychedelic drugs: a mixed methods study, PloS One, 18, 10.1371/journal.pone.0293349 · DOI
  8. Fotiou, 2019, Purging and the body in the therapeutic use of ayahuasca, Soc. Sci. Med., 239, 10.1016/j.socscimed.2019.112532 · DOI
  9. Gasser, 2015, LSD-assisted psychotherapy for anxiety associated with a life-threatening disease: a qualitative study of acute and sustained subjective effects, J. Psychopharmacol., 29, 57, 10.1177/0269881114555249 · DOI · Paper page
  10. Holze, 2022, Safety pharmacology of acute LSD administration in healthy subjects, Psychopharmacology (Berl), 239, 1893, 10.1007/s00213-021-05978-6 · DOI
  11. Ioannidis, 2009, Adverse events in randomized trials: neglected, restricted, distorted, and silenced, Arch. Intern. Med., 169, 1737, 10.1001/archinternmed.2009.313 · DOI
  12. Johnson, 2008, Human hallucinogen research: guidelines for safety, J. Psychopharmacol., 22, 603, 10.1177/0269881108093587 · DOI · Paper page
  13. Jung, 2005, Liverpool University Neuroleptic Side-Effect Rating Scale (LUNSERS) as a subjective measure of drug-induced parkinsonism and akathisia, Hum. Psychopharmacol., 20, 41, 10.1002/hup.655 · DOI
  14. Junqueira, 2023, CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials, J. Clin. Epidemiol., 158, 149, 10.1016/j.jclinepi.2023.04.005 · DOI · Paper page
  15. Klatte, 2023, Adverse events in psychotherapy randomized controlled trials: a systematic review, Psychother. Res., 1, 10.1080/10503307.2023.2286992 · DOI
  16. Muller, 2022, Flashback phenomena after administration of LSD and psilocybin in controlled studies with healthy participants, Psychopharmacology (Berl), 239, 1933, 10.1007/s00213-022-06066-z · DOI
  17. Schlag, 2022, Adverse effects of psychedelics: from anecdotes and misinformation to systematic science, J. Psychopharmacol., 10.1177/02698811211069100 · DOI
  18. Short, 2020, Development of the Ketamine Side Effect Tool (KSET), J. Affect. Disord., 266, 615, 10.1016/j.jad.2020.01.120 · DOI
  19. Simonsson, 2023, Prevalence and associations of challenging, difficult or distressing experiences using classic psychedelics, J. Affect. Disord., 326, 105, 10.1016/j.jad.2023.01.073 · DOI
  20. Strassman, 1984, Adverse reactions to psychedelic drugs. A review of the literature, J. Nerv. Ment. Dis., 172, 577, 10.1097/00005053-198410000-00001 · DOI
  21. Straumann, 2024, Safety pharmacology of acute psilocybin administration in healthy participants, Neurosci. Appl., 3, 10.1016/j.nsa.2024.104060 · DOI
  22. Uher, 2009, Adverse reactions to antidepressants, Br. J. Psychiatry, 195, 202, 10.1192/bjp.bp.108.061960 · DOI
  23. Vizeli, 2017, Safety pharmacology of acute MDMA administration in healthy subjects, J. Psychopharmacol., 31, 576, 10.1177/0269881117691569 · DOI
  24. Yao, 2024, Efficacy and safety of psychedelics for the treatment of mental disorders: a systematic review and meta-analysis, Psychiatry Res., 335, 10.1016/j.psychres.2024.115886 · DOI

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Metadata

Authors
Calder, A. E., & Hasler, G.
Affiliations
University of Freiburg (DE)
Corresponding author
Hasler, Gregor
ORCID
Venue
Journal of Affective Disorders
Publisher
Elsevier BV
Published
2024-11
Volume
365
Pages
258-264
ISSN
0165-0327 (ISSN-L)
DOI
10.1016/j.jad.2024.08.091
OpenAlex
W4401689244
Cited by
28
References
8
Citations by year
2026: 11 · 2025: 14 · 2024: 3
FWCI
11.46
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Affective Disorders (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PsyArXiv (OSF Preprints) (submittedVersion, public-domain)
Funders
Université de Fribourg
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
MDMA, questionnaire development, instrument validation, psychedelic therapy, LSD, psilocybin, patient safety, informed consent
MeSH terms
Adult, Female, Hallucinogens, Humans, Lysergic Acid Diethylamide, Male, Middle Aged, Psilocybin, Surveys and Questionnaires, Switzerland, Reproducibility of Results, N-Methyl-3,4-methylenedioxyamphetamine, Young Adult

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