Trial PaperMajor Depressive Disorder (MDD)Depressive DisordersAnxiety DisordersPalliative & End-of-Life DistressEquity and EthicsPsilocybin

Psilocybin-assisted therapy mediates psycho-social-spiritual change in cancer patients as assessed by the NIH-HEALS

This pre-print open-label trial (n=30) assessed psycho-spiritual change in cancer patients with major depressive disorder after a single dose of psilocybin (25mg). Participants underwent individual and group preparation and integration sessions, while the NIH-HEALS was used to assess psycho-spiritual change. Across all three factors (Connection, Reflection and Introspection) of the NIH-HEALS, psilocybin led to positive changes at all time points.

Authors

  • Manish Agrawal
  • Rezvan Ameli

Published

Journal of Affective Disorders
individual Study

Abstract

Background

While psychedelics have been shown to improve psycho-spiritual well-being, the underlying elements of this change are not well-characterized. The NIH-HEALS posits that psycho-social-spiritual change occurs through the factors of Connection, Reflection $ Introspection, and Trust $ Acceptance. This study aimed to evaluate the changes in NIH-HEALS scores in a cancer population with major depressive disorder undergoing psilocybin-assisted therapy.

Methods

In this Phase II, single-centre, open-label trial, 30 cancer patients with major depressive disorder received a fixed dose of 25 mg of psilocybin. Participants underwent group preparation sessions, simultaneous psilocybin treatment administered in separate rooms, and group integration sessions, along with individual care. The NIH-HEALS, a self-administered, 35-item measure of psycho-social spiritual healing, was completed at baseline and post-treatment at day 1, week 1, week 3, and week 8 following psilocybin therapy.

Results

NIH-HEALS scores, representing psycho-social-spiritual wellbeing, improved in response to psilocybin treatment (p < 0.001). All three factors of the NIH-HEALS (Connection, Reflection $ Introspection, and Trust $ Acceptance) demonstrated positive change by 12.7 %, 7.7 %, and 22.4 %, respectively. These effects were apparent at all study time points and were sustained up to the last study interval at 8 weeks (p < 0.001).

Limitations

The study lacks a control group, relies on a self-report measure, and uses a relatively small sample size with limited diversity that restricts generalizability.

Conclusions

Findings suggest that psilocybin-assisted therapy facilitates psycho-social-spiritual growth as measured by the NIH-HEALS and its three factors. This supports the factors of Connection, Reflection $ Introspection, and Trust $ Acceptance as important elements for psycho-social-spiritual healing in cancer patients and validates the use of the NIH-HEALS within psychedelic research.

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Research Summary of 'Psilocybin-assisted therapy mediates psycho-social-spiritual change in cancer patients as assessed by the NIH-HEALS'

Introduction

Shnayder and colleagues frame the study around the substantial psycho-social and spiritual burden that can accompany a cancer diagnosis, including depression, anxiety, fear of dying, disconnection and loss of meaning. They note that traditional pharmacotherapies have limited and mixed efficacy for cancer-related distress, and that psychedelic-assisted therapies such as psilocybin have re-emerged as promising interventions. Earlier clinical research and recent trials suggest psilocybin can produce large improvements in cancer-related depression, anxiety and existential distress, but the mechanisms underlying psycho-spiritual change remain incompletely characterised. The investigators focus on the NIH-HEALS, a validated 35-item self-report instrument developed from interviews with patients facing severe or life‑threatening illness; factor analysis of the measure yielded three interrelated domains thought to underpin healing: Connection, Reflection & Introspection, and Trust & Acceptance. The present study was designed to evaluate change in NIH-HEALS scores in a sample of cancer patients with Major Depressive Disorder following a fixed 25 mg dose of psilocybin administered with preparatory and integration psychotherapy. The stated aim was to test whether psilocybin-assisted therapy produces measurable improvements on the NIH-HEALS and thereby provide evidence about the psychological elements that mediate psycho-social-spiritual change.

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Study Details

References (13)

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