Ayahuasca-assisted meaning reconstruction therapy for grief : a non-randomized clinical trial protocol
Sabucedo, Pablo (University of Liverpool)
Andión Pérez, Óscar (Research Sherpas, Girona)
Neimeyer, Robert A. (Portland Institute for Loss and Transition)
Javkin, Julia (Sociedad Española de Medicina Psicodélica (SEMPsi))
Haro Abad, Josep Maria (Institut de Recerca Sant Joan de Déu)
Farré Albaladejo, Magí (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Soto-Angona, Óscar (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
González, Débora (Institut de Recerca Sant Joan de Déu)

Date:	2025
Abstract:	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. Clinical trial registration: https://clinicaltrials. gov, identifier NCT06150859.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Psychedelic-assisted therapy ; Ayahuasca ; Psychedelics ; Meaning reconstruction ; Psychotherapy ; Protocol ; Bereavement ; Prolonged grief disorder
Published in:	Frontiers in psychiatry, Vol. 15 (January 2025) , art. 1484736, ISSN 1664-0640

DOI: 10.3389/fpsyt.2024.1484736
PMID: 39839135

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