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

Abstract

Context/objectives: 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 Institutional Review Boards-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 six-months follow up data.

Methods: Outcome measures were collected at baseline, two-weeks and 26-weeks postintervention. The study involved three group preparatory sessions, one high-dose (25 mg) group psilocybin session, and three group integration sessions with cohorts of four participants over a three-week intervention.

Results: Twelve 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 two-week timepoint (21.5-10.09, P < 0.001) and the 26-week timepoint (21.5-14.83, P = 0.006). Six out of 12 participants met criteria for remission at two weeks, as defined by HAM-D < 7, three out 12 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.

Trial registration: ClinicalTrials.gov NCT05557643.

Keywords: Psilocybin; cancer; depression; palliative care; psilocybin-assisted therapy; psychedelic-assisted therapy.