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

Benjamin R. Lewis, Eric L Garland, Kevin Byrne, Tyler Durns, John Hendrick, Anna C. Beck, Paul Thielking

Journal of Pain and Symptom Management September 1, 2023 DOI: 10.1016/j.jpainsymman.2023.06.006 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Open-label feasibility and safety pilot study Peer reviewed
Sample size 12
Population Cancer patients with a DSM-5 depressive disorder (major depressive disorder or adjustment disorder with depressed mood)
Intervention Psilocybin-assisted group therapy
Dose 25 mg
Duration Three-week intervention, with follow-up at two weeks and 26 weeks postintervention
Topics Depression Psilocybin Psychedelic-assisted therapy
Keywords Palliative care Psilocybin-assisted therapy Cancer treatment Mental health Psychedelic medicine Depression therapy
Citations 60
Key points Psilocybin-assisted group therapy demonstrated safety, feasibility, and possible efficacy for reducing depressive symptoms in cancer patients, with clinically substantial decreases in HAM-D scores sustained at six months.

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 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. 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. 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). 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.

Comparable studies

Other non-randomized and open-label trials on psilocybin and psychedelic-assisted therapy, most cited first.

Study Year Design Participants
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression 2017 Open-label trial n = 20
Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Patients with major depressive disorder 2021 Open-label study n = 24
Group psychedelic therapy: empirical estimates of cost-savings and improved access Adults with PTSD or major depressive disorder eligible for psychedelic-assisted therapy... 2023 Comparative cost analysis using trial data and published estimates
Increased low-frequency brain responses to music after psilocybin therapy for depression. Patients with treatment-resistant depression 2023 Open-label trial n = 19
Group format psychedelic-assisted therapy interventions: Observations and impressions from the HOPE trial Patients with a DSM-5 depressive disorder associated with a cancer diagnosis 2023 Open-label feasibility and safety pilot study

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Depression Psilocybin Psychedelic-assisted therapy End-of-life distress

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