Psilocybin-assisted therapy improves psycho-social-spiritual well-being in cancer patients

Sarah Shnayder; Rezvan Ameli; Ninet Sinaii; Ann Berger; Manish Agrawal

doi:10.1016/j.jad.2022.11.046

Psilocybin-assisted therapy improves psycho-social-spiritual well-being in cancer patients

J Affect Disord. 2023 Feb 15:323:592-597. doi: 10.1016/j.jad.2022.11.046. Epub 2022 Dec 10.

Authors

Sarah Shnayder¹, Rezvan Ameli², Ninet Sinaii³, Ann Berger⁴, Manish Agrawal⁵

Affiliations

¹ Sunstone Therapies, Rockville, MD, United States of America. Electronic address: sarah.shnayder@sunstonetherapies.com.
² Sunstone Therapies, Rockville, MD, United States of America; Pain and Palliative Care Service, Clinical Center, National Institutes of Health, Bethesda, MD, United States of America. Electronic address: amelir@mail.nih.gov.
³ Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, United States of America. Electronic address: sinaiin@cc.nih.gov.
⁴ Pain and Palliative Care Service, Clinical Center, National Institutes of Health, Bethesda, MD, United States of America. Electronic address: aberger@cc.nih.gov.
⁵ Sunstone Therapies, Rockville, MD, United States of America. Electronic address: manish.agrawal@sunstonetherapies.com.

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-center, 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 adjacent 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 underlying elements for psycho-social-spiritual healing in cancer patients, and validates the use of the NIH-HEALS within psychedelic research.

Keywords: Cancer; Healing; NIH-HEALS; Psilocybin; Psycho-spiritual.

MeSH terms

Depressive Disorder, Major* / drug therapy
Hallucinogens* / pharmacology
Hallucinogens* / therapeutic use
Humans
Neoplasms* / drug therapy
Psilocybin / pharmacology
Psilocybin / therapeutic use
Self Report

Substances

Psilocybin
Hallucinogens

Grants and funding

Z99 CL999999/ImNIH/Intramural NIH HHS/United States