Evidence map›Paper›PMID 38632313›Full record

Trial reportScientific reports2024

Psychological flexibility as a mechanism of change in psilocybin-assisted therapy for major depression: results from an exploratory placebo-controlled trial.

Jordan Sloshower, Richard J Zeifman, Jeffrey Guss, Robert Krause, Hamideh Safi-Aghdam, Surbhi Pathania, Brian Pittman, Deepak Cyril D'Souza

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
30.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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  20. Psychedelic-Assisted Therapy: Potential Benefits and Challenges in Mental Health Treatment.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Jordan SloshowerDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. jordan.sloshower@yale.edu.ORCID 0000-0001-7709-5931
Richard J ZeifmanNYU Langone Center for Psychedelic Medicine, NYU Grossman School of Medicine, New York, NY, USA.
Jeffrey GussDepartment of Psychiatry, NYU Grossman School of Medicine, New York, NY, USA.
Robert KrauseDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Hamideh Safi-AghdamDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Surbhi PathaniaDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Brian PittmanDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Deepak Cyril D'SouzaDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Yale University · USMultidisciplinary Association for Psychedelic Studies · USNew York University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Several phase II studies have demonstrated that psilocybin-assisted therapy shows therapeutic potential across a spectrum of neuropsychiatric conditions, including major depressive disorder (MDD). However, the mechanisms underlying its often persisting beneficial effects remain unclear. Observational research suggests that improvements in psychological flexibility may mediate therapeutic effects. However, no psychedelic trials to date have substantiated this finding in a clinical sample. In an exploratory placebo-controlled, within-subject, fixed-order study, individuals with moderate to severe MDD were administered placebo (n = 19) followed by psilocybin (0.3 mg/kg) (n = 15) 4 weeks later. Dosing sessions were embedded within a manualized psychotherapy that incorporated principles of Acceptance and Commitment Therapy. Depression severity, psychological flexibility, mindfulness, and values-congruent living were measured over a 16-weeks study period. Psychological flexibility, several facets of mindfulness, and values-congruent living significantly improved following psilocybin and were maintained through week 16. Additionally, improvements in psychological flexibility and experiential acceptance were strongly associated with reductions in depression severity following psilocybin. These findings support the theoretical premise of integrating psilocybin treatment with psychotherapeutic platforms that target psychological flexibility and add to emerging evidence that increasing psychological flexibility may be an important putative mechanism of change in psilocybin-assisted therapy for MDD and potentially, other mental health conditions.

Indexed as

Acceptance and Commitment TherapyHallucinogensMajor Depressive DisorderDepressionHumansPsilocybinHallucinogensPsilocybin

Identifiers

PMID38632313
PMCPMC11024097
OpenAlexW4394886406

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.