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=17) showed that psilocybin-assisted group therapy (21-25mg/70kg) was safe and effective for the treatment of demoralization in older long-term AIDS survivors.
Authors
- Joshua Woolley
- Gabrielle Agin-Liebes
- Brian Anderson
Published
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.
Research Summary of 'Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study'
Introduction
Demoralization is described as existential suffering marked by helplessness, loss of meaning, and poor coping, and it is common among people with serious medical illnesses. Previous psychotherapies targeting demoralization have shown limited efficacy against active controls, and recent trials of psilocybin administered with adjunctive individual psychotherapy have demonstrated safety and durable symptomatic improvements for depression, anxiety and existential distress in patients with life-threatening illness. However, it is unknown whether psilocybin therapy can ameliorate demoralization in other clinical populations, or whether a group-based delivery model is feasible and safe. This pilot study sought to assess safety, feasibility, and preliminary clinical effects of psilocybin-assisted group therapy for demoralization in older long-term AIDS survivor (OLTAS) men, a population with substantial traumatic loss, social isolation and multimorbidity. Given the novelty of both the target population and the group-based approach, the investigators prioritised implementation outcomes (recruitment, tolerability, retention and protocol adherence) while treating clinical efficacy as exploratory.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- Authors
- APA Citation
Anderson, B. T., Danforth, A., Daroff, P. R., Stauffer, C., Ekman, E., Agin-Liebes, G., Trope, A., Boden, M. T., Dilley, P. J., Mitchell, J., & Woolley, J. (2020). Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. eClinicalMedicine, 27, 100538. https://doi.org/10.1016/j.eclinm.2020.100538
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