The HOPE trial reports qualitative observations from an open‑label pilot of group‑format psilocybin‑assisted therapy in people with cancer‑related depressive disorders, based on participant written reports and therapist feedback. It synthesises those impressions into practical recommendations for protocol design, screening, space and music considerations, therapist team structure and group process to inform future group‑based psychedelic therapy studies.
Papers cited by this study that are also in Blossom
Background
Psilocybin-assisted psychotherapy has demonstrated significant promise as a treatment for depression, anxiety, and existential distress associated with serious medical illness and has generally been employed on an individual basis, which presents challenges for scaling and resource availability. There are also compelling theoretical reasons to suggest that group-based formats-if utilized in a thoughtful fashion-might offer unique or enhanced therapeutic benefits for certain conditions or populations. The HOPE trial is an IRB-approved open-label feasibility and safety pilot study of psilocybin enhanced group therapy in patients with a DSM-5 depressive disorder associated with a cancer diagnosis completed at the Huntsman Cancer Institute (HCI) in Salt Lake City, Utah (HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer). We report here qualitative survey-based data, impressions, and suggestions for group-based psychedelic-assisted therapy interventions based on our observations to inform future studies.
Methods
Patients with a DSM-5 depressive disorder with an underlying cancer diagnosis were recruited from HCI by referral from oncology providers, palliative care, and social work. Following screening and consenting, 4-6 participants per cohort (with three total cohorts) were enrolled in a protocol involving 3 120 min group preparatory sessions, a single high-dose (25 mg) group psilocybin session, and 3 subsequent group integration sessions. Primary clinical outcomes are still in process of data collection and analysis. Qualitative data was gathered from patient written reports and a survey administered at 2 weeks post intervention. Qualitative reports were also gathered from the therapist team at a post-study group process session.
Findings
We report here results from a qualitative survey of participant experiences with group format study design, as well as impressions and guidelines for group format and group psychotherapeutic process to inform other studies pursuing group-based interventions in psychedelic therapy. Suggestions are provided for protocol design, screening processes, space considerations, therapist team structure, group process, music, timeline, as well as potential issues and challenges.
Lewis and colleagues situate the study in a long tradition of group use of classic psychedelics, from indigenous communal rituals to mid-20th century clinical research. The authors note that contemporary clinical trials of psilocybin-assisted therapy have largely used individual preparatory, dosing, and integration sessions with two therapists per participant, a model that poses substantial scalability challenges because of clinician time requirements. They highlight theoretical reasons why group formats might be therapeutically valuable for conditions associated with social isolation or existential distress, including the capacity of psychedelics to enhance interpersonal connectedness, prosociality, and empathy, and the known benefits of group cohesion for psychotherapy outcomes. This paper reports qualitative observations, patient-reported experience survey data, and therapist impressions from the HOPE pilot trial (HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer), an institutional review board–approved open-label feasibility and safety study of a group-format psilocybin intervention for patients with a DSM-5 depressive disorder associated with a cancer diagnosis. The authors set out to describe participants' and therapists' experiences of the group model and to offer practical suggestions for protocol design, screening, setting, therapist roles, group process, music, timeline, and potential risks to inform future group-based psychedelic trials. The trial's primary clinical outcome data were still being collected and analysed at the time of reporting; the present paper focuses on qualitative and procedural lessons from the intervention.
The HOPE trial recruited patients from the Huntsman Cancer Institute via referrals from oncology, palliative care, and social work. Eligible participants met criteria for a DSM-5 depressive disorder with an underlying cancer diagnosis; the extracted text does not provide a full enumerated list of inclusion and exclusion criteria in the body (it refers to Appendix 1 for details). Screening involved chart review, contact with referring clinicians, telephone discussion of eligibility and logistics, and an in-person psychiatric and medical evaluation including the PHQ-9 and Columbia Suicide Severity Rating Scale. Participants provided informed consent and were assigned an individual therapist prior to the first preparatory session. The intervention comprised three 120-minute group preparatory sessions (each with ~90 minutes of group process and 30 minutes of individual breakout time), a single high-dose group psilocybin session (25 mg) held in an infusion suite, and three 120-minute group integration sessions spread over two weeks. Cohorts were small (4–6 participants per cohort, three cohorts in total). The group process drew on a supportive‑expressive model commonly used in cancer support groups, with elements of psychoeducation, intention setting, mindfulness and guided imagery, and discussion of existential themes. Therapist staffing came from a multidisciplinary ten-person team (social workers, psychologists, a nurse, and MDs) who had completed brief training programs in psychedelic-assisted therapy; two therapists had completed a certificate programme. The dosing session used a communal music playlist played over room speakers rather than individual headphones, and participant/therapist dyads were positioned in semi-private bays within the infusion suite; a private 'break-out' room was available but not used. For the qualitative evaluation, the investigators collected free-form written participant reports and administered the HOPE Patient-Reported Experience Questionnaire at 2 weeks after completion of the full intervention. Ten of 12 participants completed this survey. The five Likert-format questions reported in the extracted text probed perceived efficacy of the group dosing format, changes in connection with other group members, whether the dosing session felt like a natural extension of the preparatory work, the acceptability of a communal music track, and preference for an individual music track with headphones. Therapist impressions were gathered from a post-study group process session and email requests. The paper does not report a quantitative analytic plan for these qualitative data beyond descriptive reporting of survey completion and thematic synthesis of free-text responses.
In addition to primary outcome measures this study gathered free-from qualitative reports from study participants as well as questionnaire data specifically gathering responses to the group-based protocol. 10/12 participants completed this qualitative survey, administered at 2 weeks post completion of the full study intervention. This included the following five questions related to group format (5 5 strongly agree, 4 5 agree, 3 5 neutral, 2 5 disagree, 1 5 strongly disagree) (Figs). See Supplementary materials for full Patient-Reported Experience Questionnaire results.
Regarding the premium on "set and setting" emphasized in psychedelic research, it is worth noting that our space availability presented certain challenges. To hold a psilocybin session in an infusion room in a cancer hospital for patients who have deep familiarity (and a range of associations, not altogether positive) with this space was a concern for our team. The choice of this space resulted from practical necessity rather than careful deliberation: it was the space we had available within the institution that would accommodate the size and nature of this intervention. This was discussed with participants from the first preparatory group, including careful description of the space, as well as an opportunity for participants to walk through the space beforehand to increase comfort. Even prior to enrolling in the study, participants were informed about the group nature of this intervention and the spaces we would be using. This offered time for questions and concerns to be raised and discussed both individually as well as in a group format. The study team took additional measures to de-medicalize the space with decorations and flowers. We also formalized a process of 'settling into' the space on the dosing day with participants having a set aside time in the morning (prior to dosing) to personalize their individual bay. This did not result in any negative reports. We suspect analogous constraints will present across other research sites and it is reassuring that approaching these constraints intentionally seemed to mitigate negative outcomes. Two participants described difficulty with the use of eyeshades: "would have preferred option of eye shades or no eye shades", "the mask and eye shield combination was too much for me. I also could have used some gentle stretching on the medicine day." Similarly, two participants felt the space constraints were too confining: "Instead of being in a reclining chair, maybe a couch or cot of some sort. Otherwise I thought the environment and set and setting was just what I needed". One person suggested the dosing day "include some outside time": a reasonable suggestion that nonetheless poses certain logistical challenges in the context of a monitored research study. Considerations: A. The nature and specific description of the site of the medicine session should be discussed upfront with participants, even prior to enrollment B. Even sub-ideal settings can be personalized and made more welcoming. A 'medicalized' environmentif handled intentionallyis not necessarily something to be avoided: in fact, the psychological 'content' that can be facilitated here is potentially quite therapeutically useful, provided this is facilitated in a sensitive manner. C. Features of an "ideal" space for group-based interventions remain incompletely characterized at this time. It is worth noting that participants in our trial reported that the ability to hear fellow group members during the psilocybin session enhanced a sense of group connection and was NOT experienced as a distraction. D. We propose that softening the parameters of the space as well as the therapist-to-participant ratio place may necessitate a stronger emphasis on screening and group cohesion, However it is unclear from our experience whether closer proximity or lack of partitioning would have had a positive or negative impact. E. Provision of a separate, more private 'break-out' room may be a useful feature for group work given heterogeneity of subjective experience. While the parameters for using this space remain unclear, simply having the availability can provide reassurance both to participants as well as study therapists, which likely has effects on the experience itself. In our study we did not end up using this space however had one scenario arise where the participant requested to leave the group space given perceived intolerability of the music. This was handled supportively by the individual therapist with additional support from the lead therapist and proved to be a transitory state that was worth moving through within the parameters of the group space. While we can imagine scenarios where this 'break out' room may prove necessary it seemed equally if not more important in the context of the individual therapeutic work in this situation to continue to hold the space in a group format. This participant confirmed this in subsequent integration sessions, describing a newfound ability to be present even with difficult emotional material in her life and in fact expressed deep appreciation for the music playlist and the therapist support to remain present in the group space through the experience. Therapist team structure and numbers Our model employed a 1:1 participant to therapist ratio with an additional lead therapist role not assigned to any particular participant. The lead therapist led the group process during the preparation and integration sessions and provided an overseeing role during the psilocybin session. This role was important for several reasons: a) this allowed individual therapists to focus primarily on the participant they were working with through what was a personally immersive process, b) it provided structure and a sense of leadership for the group of participants as a whole who had both the support from the group container but also from the dyad, c) it provided an additional layer of support for study therapists to process the experience, d) it ensured that the numerous practical necessities of the process were monitored from a perspective of more distanced objectivity and attention to the study demands. The break-out sessions into participant/therapist dyads was felt by participants to be a critical component of the intervention. This served to establish rapport, comfort, security/safety, and allowed for deeper exploration of autobiographical themes and intentions for the psilocybin session. We did not employ a formalized approach to assigning therapists however the team discussion about this prior to starting the intervention was an important part of our process to ensure the best fit based on available knowledge of participants throughout the screening process. Our protocol allowed for additional contact with the assigned therapist between group sessions as well as after the intervention and a majority of participants engaged with this, feeling this to be a helpful form of support. Considerations: A. There is compelling rationale for one-on-one therapeutic contact, even if optimal frequency and duration of these one-on-one interactions remains unknown. If further reductions in therapist:participant ratio are pursued, we recommend strategizing ample one-on-one contact through the process. B. While it brings the challenge of larger group size, including all therapists in the group process is an effective way of facilitating a sense of cohesion, safety, trust, and collective experience. C. The lead therapist provides a critical role due to more objective distance D. A limiting factor to number per cohort is the logistics of screening and enrolling of participants within a certain time window. Given the premium on effective screening for engaging in a group process like this it is reasonable to target lower group numbers, particularly initially.
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Papers in Blossom that reference this study
Lewis, B. R., Hendrick, J., Byrne, K. et al. · PLOS Medicine (2025)
Lewis, B. R., Garland, E. L., Byrne, K. et al. · Journal of Pain and Symptom Management (2023)
Ten of 12 participants completed the qualitative survey administered two weeks after completing the intervention. The primary clinical outcome measures were still pending analysis; the reported results therefore focus on participant narratives and therapist impressions of the group-format protocol. Participants uniformly reported positive impressions of the group-based design in response to questions assessing whether the group format maximised individual therapeutic response, increased connection to other group members, and felt like a natural extension of preparatory work. Free-text responses emphasised rapid development of interpersonal closeness and a sense that individual stories and healing journeys became "woven" together. Several participants described reduced feelings of isolation and greater capacity to co-exist with illness; one participant attributed a diminished sense of limited time to both the psilocybin session and a meditation practice. Practical feedback included mixed responses about music and sensory aids: some participants welcomed the communal speaker-driven playlist while others wished for more personalised control (for example, "choosing my own music"), and two participants expressed discomfort with restricted eye coverings, noting preferences for either no eye shades or optional use. A minority described the physical setting as confining and suggested alternatives such as a couch or outdoor time, though logistical constraints were acknowledged. Therapist reports corroborated participants' impressions of rapidly intensified group cohesion. The team observed that shared anticipatory apprehension and subsequent relief created a potent communal bond, and that preparatory and integration sessions amplified themes raised during dosing. Therapists emphasised the importance of the individual breakout segments for establishing rapport and deeper autobiographical exploration. The lead therapist role was reported as valuable for providing structure, overseeing practical necessities, and offering a degree of objective distance. The private break-out room, while not ultimately used, was considered a reassuring contingency and was briefly discussed as an option when one participant found the playlist intolerable during dosing; the participant remained in the group space with supportive dyadic interventions and later appreciated the shared process.
Lewis and colleagues interpret the qualitative data as supportive of the feasibility and acceptability of a small-group model for psilocybin-assisted therapy among patients with cancer-related depressive disorders, while emphasising caveats and practical lessons. They note that even a clinically familiar or "medical" setting can be rendered acceptable if described to participants in advance and intentionally de‑medicalised with décor and rituals; providing opportunities to walk through the space pre-enrolment and a structured settling-in period on dosing day appeared helpful. The authors argue that small cohorts, deliberate screening, and the availability of a private break-out room can mitigate risks arising from heterogeneous subjective experiences, even if the break-out room may not be frequently employed. With regard to therapist staffing and roles, the team found value in maintaining one-on-one therapist–participant dyads across the intervention while adding a lead therapist to coordinate group process and oversee safety and logistics. The dyadic break-out segments were viewed as essential for rapport, safety, and individual narrative work. The authors recommend preserving substantial one-on-one contact if future protocols pursue further reductions in therapist:participant ratios, and they highlight the benefit of including the broader therapist team in group sessions to foster cohesion and shared experience. On group process and music, the supportive‑expressive framework combined with explicit education about psilocybin was judged effective in preparing participants and building bonds that could enhance the dosing session. The communal speaker playlist was used deliberately to emphasise the shared nature of the experience; while most participants found this acceptable, some expressed a desire for personalised music options. The investigators advise explicitly framing the communal playlist during preparation and planning playlist strategy for any break-out/private spaces. The authors raise important cautions about potential harms specific to group formats. Group contexts can amplify suggestibility, social comparison, and the possibility of marginalising participants who have divergent experiences. Given increased suggestibility on psychedelics, careful, consistent therapist conduct is essential to avoid inadvertent coercion; the paper references recent visibility of coercive and abusive behaviours in psychedelic therapy contexts and frames this as a reason for deliberate protocol development. Lewis and colleagues also identify an open empirical question about the optimal psychotherapeutic adjunct for psychedelic treatments—whether non‑directive supportive approaches or more structured, directive modalities (for example CBT or ACT) will ultimately prove most efficacious. They conclude by advocating for development of both nomothetic (generalisable) and idiographic (individualised) models for psychedelic-assisted group therapy, while emphasising rigorous screening, clear safety plans, and further empirical work to characterise best practices. The extracted text also reiterates a practical recommendation that prohibited medications should be washed out for at least five half-lives prior to study registration, but does not provide further pharmacological details.