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STUDY PROTOCOL article

Front. Psychiatry
Sec. Mood Disorders
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1484736

Ayahuasca-assisted meaning reconstruction therapy for grief: A non-randomized clinical trial protocol

Provisionally accepted
  • 1 Faculty of Health and Life Sciences, University of Liverpool, Liverpool, North West England, United Kingdom
  • 2 Sociedad Española de Medicina Psicodélica (SEMPsi), Barcelona, Balearic Islands, Spain
  • 3 Research Sherpas, Girona, Spain
  • 4 Portland Institute for Loss and Transition, Portland, United States
  • 5 Parc Sanitari Sant Joan de Déu, España, Spain
  • 6 Fundació Sant Joan de Déu, Institut de Recerca Sant Joan de Déu, Barcelona, Balearic Islands, Spain
  • 7 Department of Psychiatry and Forensic Medicine, School of Medicine, Autonomous University of Barcelona, Barcelona, Catalonia, Spain
  • 8 Kiyumi collective, Hoosfdorp, Netherlands
  • 9 Heart & brain training, Nijmegen, Netherlands
  • 10 PHI Association, Barcelona, Spain, Barcelona, Balearic Islands, Spain
  • 11 Fundació Sant Joan de Déu, Institut de Recerca Sant Joan de Déu, Barcelona, Spain
  • 12 Center for Biomedical Research in Mental Health Network (CIBERSAM), Madrid, Madrid, Spain
  • 13 Department of Clinical Pharmacology, Hospital Universitari Germans Trias I Pujol-IGTP, Badalona, Spain
  • 14 Departament of Pharmacology, Therapeutics and Toxicology, Autonomous University of Barcelona, Barcelona, Spain
  • 15 Faculty of Health Sciences, University Isabel I, Burgos, Spain

The final, formatted version of the article will be published soon.

    Background. Psychotherapy for Prolonged Grief Disorder (PGD), a condition characterized by an intense and persistent grief response, has received increased attention over the past decades. Evidence-based approaches to prevent PGD are currently scarce, and not always effective. This paper introduces a protocol for a clinical trial exploring the effectiveness of a Meaning Reconstruction psychotherapy approach (MR) assisted with ayahuasca, a traditional indigenous medicine. Method. The outlined protocol is a three-arm, non-randomized controlled trial focused on reducing normal and pathological grief symptoms, comparing the effectiveness of Ayahuasca-assisted MR therapy (A-MR), MR therapy alone (MR) and No Treatment (NT). At least 69 people who lost a first-degree relative during the prior year, and with a Texas Revised Inventory of Grief score up 39 (TRIG ≥ 40), will participate in the trial. Participants will be allocated to an A-MR (n ≥ 23), MR (n ≥ 23) or NT (n ≥ 23) group. Those from the A-MR and MR therapy groups will undergo a therapeutic process involving 9 sessions of online psychotherapy. In addition, the A-MR condition involves 2 group sessions of ayahuasca. The primary outcomes will be normal and pathological grief severity as measured by the TRIG and Traumatic Grief Inventory Self-Report (TGI-SR), administered at baseline, post-treatment, and 3-month follow up. Measures of quality of life, post-traumatic growth, meaning-made, psychological flexibility, and self-belief consistency will be also included. In addition, subjective effects of ayahuasca and acceptance-avoidance promoting effects will be assessed following ayahuasca administration. Finally, we will analyze the potential mediating effect of meaning-made, psychological flexibility and self-belief consistency in grief symptoms (as measured by the TRIG and TGI). Discussion. This trial is the first to empirically examinate the potential of psychedelic-assisted psychotherapy for grief, as well as the potential processes of change that may account for it.

    Keywords: psychedelic assisted therapy, ayahuasca, psychedelics, Meaning reconstruction, Psychotherapy, protocol, bereavement, Prolonged grief disorder

    Received: 22 Aug 2024; Accepted: 08 Nov 2024.

    Copyright: © 2024 Sabucedo, Andión, Neimeyer, Soto, Javkin, Haro, Farre and González. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Débora González, Fundació Sant Joan de Déu, Institut de Recerca Sant Joan de Déu, Barcelona, Balearic Islands, Spain

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.