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Benjamin R. LewisUniversity of Utah, USA

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Kevin ByrneUniversity of Utah, USA

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John HendrickUniversity of Utah, USA

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Eric L. GarlandUniversity of Utah, USA

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Paul ThielkingUniversity of Utah, USA

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Anna BeckUniversity of Utah, USA

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Abstract

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.

Abstract

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.

Introduction

The use of classic psychedelics (understood as agonists at the serotonin 2a receptor) in group settings for religious/spiritual purposes dates back centuries. This includes traditional Mazatec communal rituals with psilocybin-containing mushrooms as well as group format ayahuasca ceremonial traditions in Central and South America. There is strong qualitative evidence to support the safety and efficacy of group classic psychedelic administration within a ritualized, culture-bound framework (Labate, 2016; Labate & Cavnar, 2014).

As detailed in the review by Trope et al. (2019), there were a number of group format classic psychedelic studies prior to rescheduling of these compounds by the DEA, including studies examining group LSD administration for patients with alcohol use disorder as well as ‘neurotic’ disorders utilizing LSD dosages in the range of 50–400 μg. Treatment modalities of these early modern trials were heterogeneous, ranging from individual high dose sessions embedded within a larger group process to studies employing group psychedelic administration.

The current model of psychedelic-assisted therapy employed in a majority of clinical trials involves individual preparatory session, 1–3 individual psilocybin sessions, and subsequent individual integration sessions with two therapists present for the duration of these encounters. This presents significant challenges for scalability. For instance, a protocol involving a single psilocybin session with this format involves 40+ clinician hours per participant. Group formats dramatically expand the scale on which these treatments can be offered, provided thoughtful analysis of risks and adequate screening procedures.

Recently there have been two trials employing variations of group format. Anderson published results of an open-label safety and feasibility pilot study on psilocybin-assisted group therapy for male AIDS survivors with demoralization (Anderson et al., 2020). This study employed group preparation and integration sessions however utilized an an individual psilocybin session with 2:1 ratio. The Aqualino Cancer Center recently reported initial results of an open-label psilocybin-assisted therapy trial for 30 patients with major depressive disorder associated with a cancer diagnosis that employed simultaneous psilocybin administration (25 mg) in individual settings with 1:1 therapist to participant ratio for 2-4 participants at a time (https://compasspathways.com/comp360-psilocybin-therapy-depression-cancer-patients/). Both of these studies expand the current model in ways that increase efficiency and suggest possible benefits to be gained by group formats, however neither of them employed a group-format psilocybin session.

Depressive and anxiety symptoms associated with a cancer diagnosis have been the target of the most robust studies on psilocybin-assisted therapy to date with demonstration of rapid and significant symptom improvement following a single high-dose psilocybin administration that is sustained longitudinally at 6 months (Griffiths et al., 2016; Grob et al., 2011; Ross et al., 2016) and even at >5 years for a significant fraction of participants (Agin-Liebes et al., 2020). No published research to date has demonstrated whether scaling this intervention to a group format is feasible and efficacious.

Given the capacities of classic psychedelics to engender feelings of interpersonal connectedness, prosociality (Weiss, Nygart, Pommerencke, Carhart-Harris, & Erritzoe, 2021) and empathy (Pokorny, Preller, Kometer, Dziobek, & Vollenweider, 2017) there are compelling reasons to hypothesize that these compounds can catalyze therapeutic effects of group therapeutic process. Feelings of social connectedness facilitated by psychedelic experiences have been described as an important causal fulcrum for therapeutic change in recent studies of patients with treatment resistant depression (Carhart-Harris et al., 2016, 2018). Participants in ceremonial ayahuasca circles within the Santo Daime or UDV traditions identify the communal nature of this experience, its situatedness within a culture and community, as critical elements to therapeutic and spiritual growth (Hartogsohn, 2021).

Further, as articulated above, group processes may augment and amplify the clinical gains induced by the psychedelic experience. Group sharing may provide indirect therapeutic suggestions to individual patients, influencing associations (Allport, 1920) and facilitating meaning-making from the experience. Moreover, contagion of a positive affective tone within the group might amplify positive emotional experiences and foster positive reappraisal of adverse experiences as a source of psychological growth (Collins, Lawrence, Troth, & Jordan, 2013). Finally, group cohesion is known to enhance psychotherapeutic treatment outcome (Burlingame, McClendon, & Alonso, 2011). We hypothesized a reciprocally synergistic effects of psychedelic experiences on group process, and of group processes on psychedelic experiences, which may promote positive clinical outcomes. The other side of this coin however suggests that group cohesion and emotional contagion may also carry unanticipated effects or risks within a group therapeutic context particularly when magnified with a classic psychedelic.

Methods

Study design

The HOPE trial (HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer) is a pilot study at the Huntsman Cancer Institute of psilocybin-assisted group therapy for patients with cancer meeting criteria for a DSM-5 depressive disorder that involves three 120-min group preparatory sessions, one high-dose (25 mg) group psilocybin session, and three 120-min group integration sessions utilizing a 1:1 therapist to participant ratio (and effectively cutting the clinician hours in half from the current standard individual model). The study was approved by an institutional IRB and participants completed an informed consent process in person prior to screening procedures and study enrollment. In addition to primary outcome measures we collected qualitative survey-based data to inform questions as to the group-format design utilizing a survey as well as free-form written responses.

10/12 participants completed the qualitative survey (HOPE Patient-Reported Experience Questionnaire) administered at 2 weeks post completion of the full study intervention. This included the following questions (5 = strongly agree, 4 = agree, 3 = neutral, 2 = disagree, 1 = strongly disagree). See Supplementary materials for full survey administered with results.

  1. I felt like the group format psilocybin session worked well and maximized my individual therapeutic response.

  2. I felt an increased connection to other group members in virtue of having a group format psilocybin session and having contact with their individual processes.

  3. I felt like the group psilocybin session was a natural extension of the group process initiated through the preparatory sessions.

  4. I felt like having a communal music track worked well.

  5. I would have preferred to have an individual music track with headphones.

The total duration of the intervention from the first preparatory session to the final integration session was 3 weeks. Referrals were made from within the Huntsman Cancer Institute. Screening involved an initial chart review and contact with referring provider and primary oncologist. Participants were then contacted over the telephone prior to enrollment to discuss the study eligibility and timeline requirements and answer questions (Please see Appendix 1 for inclusion and exclusion criteria.). Prospective participants then met individually with a study co-investigator for a full psychiatric and medical evaluation and screening questionnaires (PHQ-9, Columbia Suicide Severity Rating Scale) to ascertain eligibility. Participants were then paired prior to the first preparatory session with an individual therapist who works with them through the intervention. The group process did not follow a specific manual but utilized a supportive-expressive model commonly employed within cancer support groups.

Study therapists were drawn from a ten person multidisciplinary therapist team comprised of social workers, psychologists, a nurse, and MDs who had completed a two day training in psychedelic-assisted therapy in March 2020 led by Mary Cosimano MSW, Alan Davis PhD, and Rafael Lancelotta MS, LPC as well as a subsequent half-day training led by Mary Cosimano in January 2021. Two therapists had also completed the CIIS Certificate Program in Psychedelic Therapy and Research.

Preparatory sessions (3)

Three group preparatory sessions were held over the course of a 1-week period. These preparatory sessions were 120 min in length, with 90 min designated for group process, and 30 min designated for 1-on-1 breakout sessions with assigned individual therapists. These groups included each participant (4), each individual therapist (4), a lead therapist, and our study coordinator for a total of 10 people. Preparatory sessions were done in an auditorium in the Huntsman Cancer Institute with an arranged circle of chairs around a central table decorated with a vase of flowers for ornamentation. Please see Appendix 2 for photos of the space used.

The preparatory groups included several points of emphasis:

  1. a.Establishing rapport, comfort, safety within the group and with therapist team
  2. b.Psychoeducation regarding the study process and psilocybin subjective effects
  3. c.Intention setting
  4. d.Techniques for navigating the psychedelic experience (mantras such as “all is welcome”, “trust, let go, be open”, introduction of the concept of ‘inner healing intelligence’, a guided imagery session at the end of prep session #3, mindfulness techniques to stay grounded in the body)
  5. e.Examination of existential themes related to death, end-of-life, serious illness
  6. f.Emphasis on collective support of the group itself, norming possible reactions on dosing day, emphasizing communal nature of the experience and interconnection of group member experiences.

During the 30-min individual breakout portion of the preparatory groups each therapist/participant dyad moved to a different point in the auditorium. This period of time was intended to build comfort and safety with the assigned therapist, as well as to facilitate more in-depth exploration of personal narrative and history as well as deepen intention setting. Therapists were available to participants by phone for the duration of participation in the study, in case of need for additional support.

Psilocybin session

The group psilocybin dosing day took place in an infusion suite in the Huntsman Cancer Institute on the Saturday following the last preparatory session. This space is partitioned into semi-private bays with reclining chairs and has a full-length window along one aspect looking out into the foothills of the Wasatch mountains. See Appendix 2 for photos of the space used. Each space had a vitals machine, small table for personal items. This space was prepared prior to the session with decorative tapestries (some of which covered medical devices), flowers, and personal items of significance to create a less sterile or medicalized ambiance. A restroom as accessible in the suite.

Participant/therapist dyads were stationed in the bays to allow for some degree of privacy while ensuring that all participants could easily hear each other within the room. The infusion suite is connected to a private room with a bed which we had available as a ‘break-out room’ in case a given participant has an experience that requires increased privacy. As a study team we had a number of conversations and discussions as to scenarios that would merit use of the ‘break out room’, however, we did not employ a strict algorithm for deciding if and when to use this space. Having completed all three cohorts we did not use this break out room for any of our participants, although there was a situation where this was discussed as a possibility which will be reviewed in a later section. Full COVID precautions were observed throughout this session with participants, therapists, and study team masked for the duration of the session.

On the morning of the dosing day, participants were escorted to the room and given some time to settle into their spaces. Prior to administration of psilocybin we held a brief group session to check in with each participant, review the timeline for the day, answer any questions, and share intentions. Dosing was performed in a ceremonial manner without overt religious language with psilocybin capsules served to participants in decorated bowls, and then participants entered the infusion suite. Therapist engagement during the medicine session followed protocols similar to those employed in prior psilocybin-assisted therapy clinical trials with an emphasis on non-directive supportive interventions, and directing and reminding participants to move inwards. Light snacks and refreshments were made available later in the session. At approximately 6 h post psilocybin administration, we reconvened as a group in the space for participants to share some brief reflections of their experience. Participants left the site with a pre-arranged support person and had the ability to contact their therapist by phone the following day (Sunday) but there was no formal contact until the first integration session (the following Monday). This delay until the first integration session reflected practical scheduling constraints rather than deep intentional design.

Integration sessions (3)

The first integration session took place on the Monday following the Saturday dosing day and the integration period extended a total of 2 weeks with sessions on Monday, Friday, and the following Friday. These sessions (120 min each, again with a 30 min ‘break-out’ session with assigned individual therapists) were held in the same auditorium in the Huntsman Cancer Institute, using the same format as the preparatory sessions with participants and therapists arranged in a circle. See Appendix 2 for photos of the space used. Again, the lead therapist led the group process with input from other study therapists.

These sessions included the following points of emphasis:

  1. a.Individual sharing of experiences. Reflections on the experiences of other participants.
  2. b.Revisiting of intentions and how these surfaced or didn't surface during the experience.
  3. c.Revisiting existential themes.
  4. d.Exploration of spiritual themes that arose.
  5. e.Reflection and exploration of the group experience during the session.
  6. f.Strategies for ongoing integration of insights and psychological material including mindfulness practices, returning to the music playlist, journaling/writing/artwork/other creative expressions.
  7. g.Reflections on the temporary nature of this group and the experience itself, the impending end of the group process.
  8. h.Reflections on how, when, and if to share this experience with others in participants' lives: partners, friends, etc.
  9. i.Gathering feedback as to the group format and protocol.

Results/participant and therapist reports

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 = strongly agree, 4 = agree, 3 = neutral, 2 = disagree, 1 = strongly disagree) (Figs 15). See Supplementary materials for full Patient-Reported Experience Questionnaire results.

Fig. 1.
Fig. 1.

HOPE patient reported experience questionnaire (question 1)

Citation: Journal of Psychedelic Studies 2023; 10.1556/2054.2022.00222

Fig. 2.
Fig. 2.

HOPE patient reported experience questionnaire (question 2)

Citation: Journal of Psychedelic Studies 2023; 10.1556/2054.2022.00222

Fig. 3.
Fig. 3.

HOPE patient reported experience questionnaire (question 5)

Citation: Journal of Psychedelic Studies 2023; 10.1556/2054.2022.00222

Fig. 4.
Fig. 4.

HOPE patient reported experience questionnaire (question 6)

Citation: Journal of Psychedelic Studies 2023; 10.1556/2054.2022.00222

Fig. 5.
Fig. 5.

HOPE patient reported experience questionnaire (question 7)

Citation: Journal of Psychedelic Studies 2023; 10.1556/2054.2022.00222

Participant narrative feedback:

  • The analogy of a field trip is what helped me prepare for my experience, but when the medicine started kicking in, I was anticipating our group field trip guides to be with me when I was going “in and through”. It took me a while to realize my therapist couldn't be in the darkness of my mind with me, an I had to show up for myself. I would be my own guide.

  • All of the participants agreed that we felt very much connected to one another on a deep, almost telepathic level. I felt like the stories and the healing journeys of the other participants were woven into my own story. We were all in this day together.

  • Choosing my own music. I had to cry and release my emotion, but I felt like the music was too sad, and I couldn't stop crying. It would have been nice to listen to something happier.

  • I saw 4 people with very different ages, backgrounds and challenges all emerge calmer, and better able to co-exist with their disease. That for me, was profound. I thought the group therapy session contributed to an understanding that we are not alone with our challenges.

  • With my diagnosis of metastatic cancer, I know time is my most valuable asset. My psilocybin experience and meditation practice have both given me that gift of time. With both, the sense that my time was running out disappeared.

Therapist narrative feedback (obtained during post-intervention process group and by email request):

  • Group cohesion was intensified by all of the participants having an automatic, shared experience, both as they prepared for the dosing day as well as after dosing. The apprehension that most experienced as well as the relief after dosing, connected the participants on a more profound level.

  • The group aspect of this study was perhaps my favorite part. This medicine often produces feelings of interconnectedness, or a reminder that we are all in this together. Having an integrated group of participants and therapists, all sharing together, made it difficult to imagine anyone would feel alone or isolated. Preparatory and integration sessions were full of sparks where we would all build on comments and observations of others. There was an openness among the group where sharing was welcomed. The medicine day began with all of us sitting in a circle, and while this was not planned, many of us brought handmade gifts to offer each other. We took turns sharing our intentions and we each learned what the others were hoping to glean from this journey. This all contributed to a sense of ceremony, and felt very natural in our group environment.

  • I believe it was important that the participants were not directly interacting with each other during the medicine session itself, however, it was helpful that they were aware they were present. They could potentially hear each other, and part of their experience was knowing that they were in the same room. Overall, there was a group cohesion that amplified rapidly. In a matter of hours together, I quickly felt closer to members of our small group than people I had known for a long time. During preparatory sessions, the mere suggestion that the medicine would “bring things up” encouraged participants to openly discuss items they anticipated arising.

Discussion

Space

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:

  1. A.The nature and specific description of the site of the medicine session should be discussed upfront with participants, even prior to enrollment
  2. B.Even sub-ideal settings can be personalized and made more welcoming. A ‘medicalized’ environment – if handled intentionally – is 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.
  3. 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.
  4. 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.
  5. 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:

  1. 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.
  2. 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.
  3. C.The lead therapist provides a critical role due to more objective distance
  4. 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.

Group process

Groups were run in a supportive-expressive group therapy style which incorporated specific education and information regarding the psilocybin experience and dosing day. This did not involve a specific manual. Groups focused on building connections, exploring feelings associated with death and dying, expressing emotions, examining life priorities, and utilizing the support of important relationships with family and friends (Kissane & Ngan, 2015). We also incorporated mindfulness meditation techniques as well as guided-imagery sessions.

Questions #1–3 assessed participant responses to the group format with all participants reporting significant positive impressions of the group-based protocol and no negative reports. Free-form qualitative reports also supported the success of this model.

While group-based interventions offer a number of advantages in terms of efficiency, and possible benefits as to therapeutic outcomes in certain populations, there is a concomitant increase in the number of variables throughout the process that introduce logistical challenges as well as unpredictability.

Considerations:

  1. A.Supportive Expressive Group Therapy principles, in combination with education regarding the effects of psilocybin, provide a potentially effective ‘hybrid’ group model that can serve to prepare group members for their psilocybin experience, while building group bonds that can potentially enhance the psilocybin experience.
  2. B.Provide balance between education about the effects of psilocybin and allowing time for the open exploration of emotions and development of group relationships.
  3. C.Emphasize safety and confidentiality from the outset of the group process.
  4. D.While adhering to supportive expressive group therapy themes seems to be of benefit, it can be helpful to maintain an open attitude towards whatever arises in the group experience, and it is not necessary to follow a rigid structured group format.
  5. E.Recognize that individuals in the group have varied prognoses and experiences, and to emphasize that individual experiences can edify rather than detract from the group dynamic.

Music

Our intervention employed a playlist designed by a member of the study team member (https://open.spotify.com/playlist/4wgi37zvjxdBHiwX9S04ot?si=6934241d8f6548dc). There are many questions as to optimal use of music as a therapeutic agent during psychedelic-assisted therapy which at present remain unanswered. The playlist was presented as a therapeutic tool for the session itself: that even negative reactions to the music can be invited in (similar to difficult psychological content) and that there may be significant personal benefit or insight as a result. We made the decision to use a speaker system in the room rather than individual head-sets: this was aligned with implicit and explicit emphasis on the group nature of the intervention. If there were other noises in the room from participants or therapists this too was to be welcomed in as a feature rather than a bug. As a study team we felt that this emphasized the communal nature of the experience and the connection between participants. This strategy is also parsimonious in terms of study cost, ensuring sound consistency and quality for participants, and minimizing wires in the group space presenting a trip hazard.

Participant reports were mixed as to the success of a communal playlist based on questions #4 and #5. While a significant majority of participants felt that a communal track worked well some participants did express a preference for a more individual music experience with headphones. One participant expressed a desire for “choosing my own music. I had to cry and release my emotion, but I felt like the music was too sad, and I couldn't stop crying. It would have been nice to listen to something happier.”

Considerations:

  1. A.There may be good rationale for not using personal headphone sets for participants provided that the use of a communal speaker-driven music playlist is framed explicitly and deliberately during the preparation sessions.
  2. B.While participants are still directed internally, there are possible therapeutic benefits to opening up the sense of what is therapeutically directed for them: i.e. just as the particular music tracks can be emphasized as a specific tool the noises in the room itself and the relationship to other participants can itself be framed and employed as a therapeutic tool. The mantra “all is welcome” is helpful in characterizing this for participants and therapists alike, i.e. on inspection this is a radical invitation that doesn't draw lines. This emphasis is equally as important for the therapist group. The limits and optimization of this strategy remain unknown however it does suggest interesting directions for further research.
  3. C.If a “break-out” room is used this necessitates a strategy for the playlist within that space.
  4. D.There remain important questions as to the therapeutic value of more personally designed playlists vs. protocol driven playlists.

Potential issues and future directions

Group-based psychedelic-assisted therapy models have significant promise both in terms of efficiency and scalability of the intervention as well as augmentation of therapeutic effect there are some caveats worth mentioning. Even with explicit emphasis on themes of acceptance and ‘letting go’, group format preparation and integration can nonetheless implicitly suggest that there are more or less ‘right’ or ‘wrong’ ways the session can go. This can present with comparison between group members and potentially even subtle marginalization of a group member who may have had a divergent experience from the norm. Classic psychedelics have demonstrated effects at increasing suggestibility (Carhart-Harris et al., 2015). This psychological effect can likely be leveraged in therapeutic directions. However, it also suggests that certain risks may be amplified in a group setting given known dynamic of enhanced social suggestibility within groups even sober. Hypothesized enhanced suggestibility in this format also implies a large degree of care, deliberation, and consistency in terms of therapist contributions during the group process. Effects of enhanced suggestibility have no doubt contributed to the frequency of coercive or abusive behaviors on the part of psychedelic therapists which has been receiving increased visibility as of late (Ross LK, n.d.). This tension between more open-ended and non-directive styles of therapy and more directed therapeutic approaches presents an ongoing series of empirical questions for the field.

It remains an open question as to whether non-directive, supportive psychotherapy models present the optimal behavioral adjunct to psychedelic therapy, or whether more directive and structured therapy approaches (e.g., CBT, ACT, mindfulness-based interventions) might be the most efficacious adjunct. More directive approaches may require clearer conceptual frameworks regarding the pathogenic mechanisms that undergird the patient's specific malady, as well as a clear conceptualization of how the specific psychological processes activated by a given psychedelic (and accompanying behavioral techniques) might be leveraged to target these mechanisms. To optimize the efficacy of psychedelic-assisted group therapy, the field should strive to develop nomothetic and idiographic psychedelic treatment models, while being attentive to the pitfalls of enhanced suggestibility and possibilities of coercion.

Funding

Internally funded through the University of Utah Huntsman Cancer Institute. Trial with institutional IRB approval and pre-registered on www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05557643). Study drug provided by Usona.

Supplementary materials

Supplementary data to this article can be found online at https://doi.org/10.1556/2054.2022.00222.

References

  • Agin-Liebes, G. I., Malone, T., Yalch, M. M., Mennenga, S. E., Ponté, K. L., Guss, J., et al. (2020). Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. Journal of Psychopharmacology (Oxford, England), 34(2), 155166. https://doi.org/10.1177/0269881119897615.

    • Search Google Scholar
    • Export Citation
  • Allport, F. H. (1920). The influence of the group upon association and thought. Journal of Experimental Psychology, 3, 159182. https://doi.org/10.1037/h0067891.

    • Search Google Scholar
    • Export Citation
  • Anderson, B. T., Danforth, A., Daroff, P. R., Stauffer, C., Ekman, E., Agin-Liebes, G., et al. (2020). Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine, 27, 100538. https://doi.org/10.1016/j.eclinm.2020.100538.

    • Search Google Scholar
    • Export Citation
  • Burlingame, G. M., McClendon, D. T., & Alonso, J. (2011). Cohesion in group therapy. Psychotherapy, 48(1), 3442 (n.d.).

  • Carhart-Harris, R. L., Bolstridge, M., Day, C. M. J., Rucker, J., Watts, R., Erritzoe, D. E., et al. (2018). Psilocybin with psychological support for treatment-resistant depression: Six-month follow-up. Psychopharmacology, 235(2), 399408.

    • Search Google Scholar
    • Export Citation
  • Carhart-Harris, R. L., Bolstridge, M., Rucker, J., Day, C. M., Erritzoe, D., Kaelen, M., et al. (2016). Psilocybin with psychological support for treatment-resistant depression: An open-label feasibility study. The Lancet Psychiatry, 3(7), 619627.

    • Search Google Scholar
    • Export Citation
  • Carhart-Harris, R. L., Kaelen, M., Whalley, M. G., Bolstridge, M., Feilding, A., & Nutt, D. J. (2015). LSD enhances suggestibility in healthy volunteers. Psychopharmacology, 232(4), 785794. https://doi.org/10.1007/s00213-014-3714-z.

    • Search Google Scholar
    • Export Citation
  • Collins, A. L., Lawrence, S. A., Troth, A. C., & Jordan, P. J. (2013). Group affective tone: A review and future research directions. Journal of Organizational Behavior, 34(S1), S43-S62. https://doi.org/10.1002/job.1887.

    • Search Google Scholar
    • Export Citation
  • Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A., Richards, W. A., Richards, B. D., et al. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology, 30(12), 11811197. https://doi.org/10.1177/0269881116675513.

    • Search Google Scholar
    • Export Citation
  • Grob, C. S., Danforth, A. L., Chopra, G. S., Hagerty, M., McKay, C. R., Halberstadt, A. L., et al. (2011). Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Archives of General Psychiatry, 68(1), 7178.

    • Search Google Scholar
    • Export Citation
  • Hartogsohn, I. (2021). Set and setting in the Santo Daime. Frontiers in Pharmacology, 12. https://www.frontiersin.org/articles/10.3389/fphar.2021.651037.

    • Search Google Scholar
    • Export Citation
  • Kissane, D. W., & Ngan, C. (2015). Supportive-expressive and other forms of group psychotherapy in cancer care. In J. C. Holland, W. S. Breitbart, P. B. Jacobsen, M. J. Loscalzo, R. McCorkle, & P. N. Butow (Eds.), Psycho-oncology (p. 0). Oxford University Press. https://doi.org/10.1093/med/9780199363315.003.0070.

    • Search Google Scholar
    • Export Citation
  • Labate, B. (2016). Peyote: History, tradition, politics, and conservation. ABC-CLIO; 2016. ABC-CLIO.

  • Labate, B. C., & Cavnar, C. (2014). Ayahuasca Shamanism in the Amazon and beyond (pp. 315). Oxford University Press (n.d.).

  • Pokorny, T., Preller, K. H., Kometer, M., Dziobek, I., & Vollenweider, F. X. (2017). Effect of psilocybin on empathy and moral decision-making. International Journal of Neuropsychopharmacology, 20(9), 747757. https://doi.org/10.1093/ijnp/pyx047.

    • Search Google Scholar
    • Export Citation
  • Ross, LK. (n.d.). Psymposia. [Podcast]. from https://www.psymposia.com/powertrip/ [Retrieved 29 June 2022].

  • Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T., Cohen, B., et al. (2016). Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. Journal of Psychopharmacology, 30(12), 11651180. https://doi.org/10.1177/0269881116675512.

    • Search Google Scholar
    • Export Citation
  • Trope, A., Anderson, B. T., Hooker, A. R., Glick, G., Stauffer, C., & Woolley, J. D. (2019). Psychedelic-assisted group therapy: A systematic review. Journal of Psychoactive Drugs, 51(2), 174188. https://doi.org/10.1080/02791072.2019.1593559.

    • Search Google Scholar
    • Export Citation
  • Weiss, B., Nygart, V., Pommerencke, L. M., Carhart-Harris, R. L., & Erritzoe, D. (2021). Examining psychedelic-induced changes in social functioning and connectedness in a naturalistic online sample using the five-factor model of personality. Frontiers in Psychology, 12. https://www.frontiersin.org/article/10.3389/fpsyg.2021.749788.

    • Search Google Scholar
    • Export Citation

Appendix 1

Inclusion Criteria

_____ Male or female, age >25, diagnosed with cancer and currently undergoing treatment or completed treatment within <26 weeks of study registration.

_____ Life expectancy >3 months.

_____ Not taking regularly scheduled medications to treat depression and/or anxiety, including benzodiazepines, for at least 4 weeks prior to initiation of the study.

_____ PHQ-9 ≥ 10 within 28 days of registration.

_____ Fluent in English.

_____ Reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.

_____ Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

_____ ECOG Performance Status >2.

_____ Have a support person that would be able to escort the subject home on the evening of the psilocybin dosing session. However, the use of ride services will not be permitted (e.g., Uber, Lift, taxi, etc.)

_____ Adequate liver function as defined as:

Total Bilirubin <1.5x institutional upper limit of normal (ULN) unless elevated bilirubin is related to Gilbert's Syndrome.

AST(SGOT)/ALT(SGPT) < 3 x institutional ULN.

_____ For female subjects: Negative pregnancy test and agreement to use highly effective contraception (as described in Section 7.2) or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.

_____ For male subjects: agree to condom use during intercourse for 24 h post-psilocybin dose.

_____ Agree to refrain from using any psychoactive drugs, including alcoholic beverages, ondansetron, cannabis, and non-routine PRN medications within 24 h of each psilocybin administration. Exceptions include daily use of caffeine, nicotine, and opioid pain medication (see Section 6.2.2).

_____ Agree that for one week preceding the psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

_____ Agree not to use nicotine for at least 2 h before the psilocybin administration or for the duration of the psilocybin session.

_____ Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the psilocybin session. If the subject does not routinely consume caffeinated beverages, he or she must agree not to do so on the day of psilocybin administration.

_____ Subjects requiring opioid use for pain are on a stable pain management regimen. Long-acting opioid medications (e.g., oxycodone sustained-release, morphine sustained release) will be allowed if the last dose occurred at least 6 h before psilocybin administration; such medication will not be taken again until at least 6 h after psilocybin administration.

_____ Have a support person that would be able to escort the subject home on the evening of the psilocybin session. The use of ride services will not be permitted.

Exclusion Criteria

_____ Prior systemic antidepressants, antipsychotic, or anxiolytic medication within four weeks prior to study initiation.

_____ Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness.

_____ Currently meeting DSM-5 criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin.

_____ Currently meeting DSM-5 criteria for Cluster B Personality Disorder.

_____ Severe depression requiring immediate standard-of-care treatment (e.g.,hospitalization).

_____ Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section.

_____ Cancer with known CNS involvement, previously treated brain metastasis, or other major CNS disease.

Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). Current substance use disorders may be identified through the drug urine screening test.

_____ Employment as Emergency Department house staff.

_____ The subject has uncontrolled significant intercurrent or recent illness including, but not limited to, the following conditions:

Cardiovascular disorders:

  1. -Congestive heart failure, including all New York Heart Association Classes.
  2. -Angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction
  3. -Uncontrolled hypertension at the time of enrollment (BP>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve
  4. -Prolonged or congenital long QT syndrome (>450 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality
  5. -Renal insufficiency as defined as creatinine clearance <40 mL min−1 calculated by Cockcroft-Gault formula

Hepatic disorders:

  1. -Active infection including hepatitis B (known positive HBV surface antigen (HBsAg) result) or hepatitis C.
  2. -Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication [patients may not receive the drug through a feeding tube], social/psychological issues, etc.)

_____ Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade >3).

______ Subjects taking prohibited medications. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration.

Appendix 2 Photos of therapy space.

Photo credit: Benjamin Lewis MD.

Auditorium (site of preparation and integration session)

Huntsman Cancer Institute BMT Infusion Suite: site of the group psilocybin administration.

BMT infusion suite, prior to decoration.

BMT infusion suite, in process of decoration.

Ceremonial bowls for dosing, and spontaneous gifts from the therapist team.

c.

BMT infusion suite (dosing room) post decoration and in session (with identifying features blacked out)

Supplementary Materials

  • Agin-Liebes, G. I., Malone, T., Yalch, M. M., Mennenga, S. E., Ponté, K. L., Guss, J., et al. (2020). Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. Journal of Psychopharmacology (Oxford, England), 34(2), 155166. https://doi.org/10.1177/0269881119897615.

    • Search Google Scholar
    • Export Citation
  • Allport, F. H. (1920). The influence of the group upon association and thought. Journal of Experimental Psychology, 3, 159182. https://doi.org/10.1037/h0067891.

    • Search Google Scholar
    • Export Citation
  • Anderson, B. T., Danforth, A., Daroff, P. R., Stauffer, C., Ekman, E., Agin-Liebes, G., et al. (2020). Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine, 27, 100538. https://doi.org/10.1016/j.eclinm.2020.100538.

    • Search Google Scholar
    • Export Citation
  • Burlingame, G. M., McClendon, D. T., & Alonso, J. (2011). Cohesion in group therapy. Psychotherapy, 48(1), 3442 (n.d.).

  • Carhart-Harris, R. L., Bolstridge, M., Day, C. M. J., Rucker, J., Watts, R., Erritzoe, D. E., et al. (2018). Psilocybin with psychological support for treatment-resistant depression: Six-month follow-up. Psychopharmacology, 235(2), 399408.

    • Search Google Scholar
    • Export Citation
  • Carhart-Harris, R. L., Bolstridge, M., Rucker, J., Day, C. M., Erritzoe, D., Kaelen, M., et al. (2016). Psilocybin with psychological support for treatment-resistant depression: An open-label feasibility study. The Lancet Psychiatry, 3(7), 619627.

    • Search Google Scholar
    • Export Citation
  • Carhart-Harris, R. L., Kaelen, M., Whalley, M. G., Bolstridge, M., Feilding, A., & Nutt, D. J. (2015). LSD enhances suggestibility in healthy volunteers. Psychopharmacology, 232(4), 785794. https://doi.org/10.1007/s00213-014-3714-z.

    • Search Google Scholar
    • Export Citation
  • Collins, A. L., Lawrence, S. A., Troth, A. C., & Jordan, P. J. (2013). Group affective tone: A review and future research directions. Journal of Organizational Behavior, 34(S1), S43-S62. https://doi.org/10.1002/job.1887.

    • Search Google Scholar
    • Export Citation
  • Griffiths, R. R., Johnson, M. W., Carducci, M. A., Umbricht, A., Richards, W. A., Richards, B. D., et al. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology, 30(12), 11811197. https://doi.org/10.1177/0269881116675513.

    • Search Google Scholar
    • Export Citation
  • Grob, C. S., Danforth, A. L., Chopra, G. S., Hagerty, M., McKay, C. R., Halberstadt, A. L., et al. (2011). Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Archives of General Psychiatry, 68(1), 7178.

    • Search Google Scholar
    • Export Citation
  • Hartogsohn, I. (2021). Set and setting in the Santo Daime. Frontiers in Pharmacology, 12. https://www.frontiersin.org/articles/10.3389/fphar.2021.651037.

    • Search Google Scholar
    • Export Citation
  • Kissane, D. W., & Ngan, C. (2015). Supportive-expressive and other forms of group psychotherapy in cancer care. In J. C. Holland, W. S. Breitbart, P. B. Jacobsen, M. J. Loscalzo, R. McCorkle, & P. N. Butow (Eds.), Psycho-oncology (p. 0). Oxford University Press. https://doi.org/10.1093/med/9780199363315.003.0070.

    • Search Google Scholar
    • Export Citation
  • Labate, B. (2016). Peyote: History, tradition, politics, and conservation. ABC-CLIO; 2016. ABC-CLIO.

  • Labate, B. C., & Cavnar, C. (2014). Ayahuasca Shamanism in the Amazon and beyond (pp. 315). Oxford University Press (n.d.).

  • Pokorny, T., Preller, K. H., Kometer, M., Dziobek, I., & Vollenweider, F. X. (2017). Effect of psilocybin on empathy and moral decision-making. International Journal of Neuropsychopharmacology, 20(9), 747757. https://doi.org/10.1093/ijnp/pyx047.

    • Search Google Scholar
    • Export Citation
  • Ross, LK. (n.d.). Psymposia. [Podcast]. from https://www.psymposia.com/powertrip/ [Retrieved 29 June 2022].

  • Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T., Cohen, B., et al. (2016). Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. Journal of Psychopharmacology, 30(12), 11651180. https://doi.org/10.1177/0269881116675512.

    • Search Google Scholar
    • Export Citation
  • Trope, A., Anderson, B. T., Hooker, A. R., Glick, G., Stauffer, C., & Woolley, J. D. (2019). Psychedelic-assisted group therapy: A systematic review. Journal of Psychoactive Drugs, 51(2), 174188. https://doi.org/10.1080/02791072.2019.1593559.

    • Search Google Scholar
    • Export Citation
  • Weiss, B., Nygart, V., Pommerencke, L. M., Carhart-Harris, R. L., & Erritzoe, D. (2021). Examining psychedelic-induced changes in social functioning and connectedness in a naturalistic online sample using the five-factor model of personality. Frontiers in Psychology, 12. https://www.frontiersin.org/article/10.3389/fpsyg.2021.749788.

    • Search Google Scholar
    • Export Citation
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Journal of Psychedelic Studies
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Journal of Psychedelic Studies
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Founder Akadémiai Kiadó
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