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

Pablo Sabucedo, Óscar Andión, Robert A Neimeyer, Oscar Soto-Angona, Julia Javkin, Josep Maria Haro, Magí Farré, Débora González

Frontiers in Psychiatry 2024 DOI: 10.3389/fpsyt.2024.1484736 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Non-randomized controlled trial Peer reviewed
Sample size 69
Population People who lost a first-degree relative during the prior year with a Texas Revised Inventory of Grief score of 40 or higher
Intervention Ayahuasca-assisted Meaning Reconstruction therapy
Duration 9 sessions of online psychotherapy with 2 group ayahuasca sessions; assessments at baseline, post-treatment, and 3-month follow-up
Topics Ayahuasca Psychedelic-assisted therapy
Keywords Bereavement Meaning reconstruction Prolonged grief disorder Protocol Psychedelics Psychotherapy Psychedelic medicine Psychedelic treatment Grief counseling Clinical trial Scientific study
Citations 4
Registration NCT06150859
Key findings The protocol outlines a trial to evaluate whether ayahuasca-assisted Meaning Reconstruction therapy reduces prolonged grief symptoms compared to therapy alone or no treatment.

Abstract

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. 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). 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. https://clinicaltrials.gov, identifier NCT06150859.

Comparable studies

Other non-randomized and open-label trials on ayahuasca, most cited first.

Study Year Design Participants
Antidepressant Effects of a Single Dose of Ayahuasca in Patients With Recurrent Depression Patients with recurrent depression 2015 Open-label trial n = 17
Assessing the Psychedelic “After-Glow” in Ayahuasca Users: Post-Acute Neurometabolic and Functional Connectivity Changes Are Associated with Enhanced Mindfulness Capacities Healthy volunteers 2017 Open-label uncontrolled study n = 16
Rapid and sustained decreases in suicidality following a single dose of ayahuasca among individuals with recurrent major depressive disorder: results from an open-label trial. Individuals with recurrent major depressive disorder 2021 Open-label trial (secondary analysis) n = 17
Pilot Evaluation of a Residential Drug Addiction Treatment Combining Traditional Amazonian Medicine, Ayahuasca and Psychotherapy on Depression and Anxiety Male patients in an inpatient addiction treatment program 2020 Pre-post observational study n = 31
Long-term effects of ayahuasca in patients with recurrent depression: a 5-year qualitative follow-up Patients with treatment-resistant major depressive disorder who had participated in an... 2018 Long-term follow-up of an open-label trial n = 8

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Ayahuasca Psychedelic-assisted therapy