Therapeutic setting as an essential component of psychedelic research methodology: Reporting recommendations emerging from clinical trials of 3,4-methylenedioxymethamphetamine for post-traumatic stress disorder
Lauren Okano, Bri Deyo, Alida Brandenburg, Wesley Hale, Gregory V. Jones
Frontiers in Psychiatry November 3, 2022 DOI: 10.3389/fpsyt.2022.965641 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review and proposal of reporting guidelines Peer reviewed |
|---|---|
| Topics | PTSD MDMA |
| Keywords | Psychotherapist Clinical trial Clinical psychology |
| Citations | 24 |
| Key findings | Reporting guidelines for key setting variables in psychedelic-assisted therapy clinical trials are proposed, based on recommendations from MDMA-for-PTSD research, to enhance empirical examination of setting's influence on treatment efficacy. |
Abstract
Research of psychedelic assisted therapies is at an all-time high, though few studies highlight extra-pharmacological factors that may affect treatment efficacy. One critical set of attributes includes the therapeutic setting itself, which describe the physical and socio-cultural environments in which the drug-assisted session occurs. Despite enduring consensus of the influence of setting, recommendations for establishing and reporting key setting variables remain sparse across clinical trial protocols and published research methodologies. The purpose of this paper is to: (1) present what is known of the influence and implications of setting to psychedelic-assisted therapies, with a particular focus on 3,4-methylenedioxymethamphetamine (MDMA); and (2) propose a set of reporting guidelines for operationalizing and reporting key setting variables in clinical trials of psychedelic-assisted therapies, based on recommendations emerging from clinical trials of MDMA for PTSD. In fact, recommendations should be expanded to “set” - the subject's mood, expectations, and broader psychological condition - once this is more fully developed in the field. The proposed reporting guidelines offer a means of increasing the volume and variability of data necessary for future empirical examination of key setting attributes influencing treatment efficacy, while preserving practitioner and patient autonomy to co-construct adaptive therapy settings according to their respective needs and expertise.
Comparable studies
Other narrative reviews on MDMA for PTSD, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA. | 2016 | Review | |
| MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms? | 2018 | Review | |
| Clinical applications of hallucinogens: A review. | 2016 | Review | |
| MDMA‐Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder: A Systematic Review With Meta‐Analysis | 2021 | Review | |
| Registered clinical studies investigating psychedelic drugs for psychiatric disorders. Registered clinical trials on clinicaltrials.gov evaluating psychedelics for... | 2021 | Review | n = 70 |
Citations in the library
Cited by 19
- Optimizing outcomes in psilocybin therapy: Considerations in participant evaluation and preparation. Journal of Affective Disorders April 1, 2023
- Set and Setting for Psychedelic Harm Reduction Psychedelic Harm Reduction 2026
- Harnessing Pharmacogenomics in Clinical Research on Psychedelic‐Assisted Therapy Clinical Pharmacology & Therapeutics September 30, 2024
- VR models of death and psychedelics: an aesthetic paradigm for design beyond day-to-day phenomenology Frontiers in Virtual Reality January 29, 2024
- Set and setting of psychedelics for therapeutic use in psychiatry: A systematic review Journal of Psychopharmacology May 12, 2025
and 14 more in the library
Cites 30
- Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry May 17, 2016
- Human hallucinogen research: guidelines for safety. Journal of Psychopharmacology July 1, 2008
- Psychedelics and the essential importance of context. Journal of Psychopharmacology February 15, 2018
- Set and setting, psychedelics and the placebo response: An extra-pharmacological perspective on psychopharmacology Journal of Psychopharmacology November 16, 2016
- Constructing drug effects: A history of set and setting Drug Science, Policy and Law 2017
and 25 more in the library