HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer.

Abstract

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. 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. 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). 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. This article describes a single-arm, open-label pilot study of psilocybin-assisted group therapy for patients dealing with symptoms of depression associated with a cancer diagnosis. Results indicate that this intervention was safe and feasible with a suggestion of efficacy. Group-format psilocybin-assisted therapy is a promising methodology that addresses challenges of scalability.