Psilocybin-assisted therapy mediates psycho-social-spiritual change in cancer patients as assessed by the NIH-HEALS
Agrawal, M., Ameli, R., Berger, A., Shnayder, S., Sinaii, N.
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.
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.