HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer
Beck, A., Byrne, K., Durns, T., Garland, E. L., Hendrick, J., Lewis, B. R., Thielking, P.
This open-label study (n=12) investigates the potential of psilocybin-assisted group therapy (PAT) in cancer patients suffering from depression. Participants underwent preparatory sessions, a high-dose (25mg) psilocybin group session, and integration sessions over three weeks, with clinical outcomes measured at baseline, two weeks, and 26 weeks post-intervention. Results show significant decreases in depression symptoms and no serious adverse events, suggesting safety, feasibility, and possible efficacy of the therapy.
Abstract
Background Psilocybin-assisted psychotherapy shows promise in treating depression and existential distress in people with serious medical illness. However, its individual-based methodology poses challenges for scaling and resource availability. The HOPE trial (A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer) is an IRB-approved open-label feasibility and safety pilot study examining psilocybin-assisted group therapy in cancer patients with a DSM-5 depressive disorder (including major depressive disorder as well as adjustment disorder with depressed mood). We report here the safety and clinical outcome measures including 6-month follow up data.Methods Outcome measures were collected at baseline, 2-week and 26-weeks post intervention. The study involved three group preparatory sessions, one high-dose (25mg) group psilocybin session, and three group integration sessions with cohorts of four participants over a three week intervention.Results 12 participants completed the trial. No serious adverse events attributed to psilocybin occurred. The primary clinical outcome measures of change in symptoms of depression on the clinician administered 17-item-HAM-D showed clinically substantial decrease in HAM-D scores from baseline to the 2-week timepoint (21.5 to 10.09, p<0.001) and the 26-week timepoint (21.5 to 14.83, p=0.006). Six out of twelve participants met criteria for remission at 2 weeks, as defined by HAM-D < 7, three out twelve demonstrated a clinically significant change (4-6 points), and eight out of twelve demonstrated a clinically substantial change (7-12 points).Conclusion This pilot study demonstrated the safety, feasibility, and possible efficacy of psilocybin-assisted group therapy for cancer patients dealing with depressive symptoms. Based on demonstrated efficacy and significant reductions in therapist time, future investigations with the group therapy model are warranted.