Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study

This open-label feasibility study (n=18) showed that psilocybin-assisted group(!) therapy (21mg) was safe and effective for the treatment of demoralization in older long-term AIDS survivors.

Abstract

Background Psilocybin therapy has shown promise as a rapid-acting treatment for depression, anxiety, and demoralization in patients with serious medical illness (e.g., cancer) when paired with individual psychotherapy. This study assessed the safety and feasibility of psilocybin-assisted group therapy for demoralization in older long-term AIDS survivor (OLTAS) men, a population with a high degree of demoralization and traumatic loss.

Methods Self-identified gay men OLTAS with moderate-to-severe demoralization (Demoralization Scale-II ≥8) were recruited from the community of a major US city for a single-site open-label study of psilocybin-assisted group therapy comprising 8–10 group therapy visits and one psilocybin administration visit (0·3–0·36 mg/kg po). Primary outcomes were rate and severity of adverse events, and participant recruitment and retention. The primary clinical outcome was change in mean demoralization from baseline to end-of-treatment and to 3-month follow-up assessed with a two-way repeated measures ANOVA.

Findings From 17 July 2017 to 16 January 2019, 18 participants (mean age 59·2 years (SD 4·4)) were enrolled, administered group therapy and psilocybin, and included in intent-to-treat analyses. We detected zero serious adverse reactions and two unexpected adverse reactions to psilocybin; seven participants experienced self-limited, severe expected adverse reactions. We detected a clinically meaningful change in demoralization from baseline to 3-month follow-up (mean difference -5·78 [SD 6·01], ηp2 = 0·47, 90% CI 0·21–0·60).

Interpretation We demonstrated the feasibility, relative safety, and potential efficacy of psilocybin-assisted group therapy for demoralization in OLTAS. Groups may be an effective and efficient means of delivering psychotherapy pre- and post-psilocybin to patients with complex medical and psychiatric needs.”

Authors: Brian T. Anderson, Alicia Danforth, Robert Daroff, Christopher Stauffer, Eve Ekman, Gabrielle Agin-Liebes, Alexander Trope, Matthew Tyler Boden, James Dilley, Jennifer Mitchell & Joshua D. Woolley

Notes

This paper is included in our ‘Top 10 Articles on Psychedelics in the Year 2020

You can find the study-protocol here.

This study was supported by: Carey Turnbull, Heffter Research Institute, NIMH R25 MH060482, NIH UL1 TR001872, River Styx Foundation, Saisei Foundation, Sarlo Foundation, Stupski Foundation, Usona Institute, US Department of Veterans Affairs (Advanced Neurosciences Fellowship and IK2CX001495).

A (positive) commentary can also be found at ‘Psilocybin-assisted group therapy: A new hope for demoralization‘.

And a further analysis also on Psychiatry & Behavioral Health Learning Network.

This study has a follow-up by Stauffer and colleagues (2020) which finds that attachment anxiety was decreased up to three months later.

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