Clinical TrialSingle-armPalliative & End-of-Life DistressPsilocybinCompleted

Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

Open-label, single-group pilot (n=30) testing one oral psilocybin session combined with ten-session manualised group psychotherapy for demoralization in long-term AIDS survivors.

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Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label mixed-methods pilot of one individual oral psilocybin session combined with ten twice-weekly sessions of manualised brief Supportive-Expressive Group Therapy for existential distress in long-term AIDS survivors.

Primary aim was feasibility and safety; outcomes included measures of demoralization, distress and depression with qualitative assessments embedded.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

10 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Group therapy + psilocybin

experimental

Modified brief Supportive-Expressive Group Therapy (ten twice-weekly sessions) plus one individual oral psilocybin session.

Interventions

  • Psilocybin
    via Oral• single dose

    One individual oral psilocybin treatment session; dose not stated in registry fragment.

  • Compound
    via Other• ten sessions

    Modified brief Supportive-Expressive Group Therapy: manualised, twice-weekly group sessions

Participants

Ages
50 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criterion:
  • Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.

Exclusion Criteria

  • Exclusion Criteria:
  • A physical, neurological or cognitive condition that makes participating in the study unsafe or unfeasible.
  • Regular psychotropic medication use.
  • Personal or family history of serious mental illness.
  • Severe depression requiring immediate standard-of-care treatment.
  • Exclusion by the clinical judgment of the study investigators.

Study Protocol, Arms & Participants

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Study Details

Locations

University of California, San Francisco — San Francisco, California, United States

Related Publications

Open AccessindividualPrimary

Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study

This open-label feasibility study (n=17) showed that psilocybin-assisted group therapy (21-25mg/70kg) was safe and effective for the treatment of demoralization in older long-term AIDS survivors.

Published
Journal
EClinicalMedicine
Authors
Anderson, B. T., Danforth, A. L., Daroff, R., Stauffer, C., Ekman, E., Agin-Liebes, G. I., Trope, A., Boden, M. T., Dilley, J., Mitchell, J., Woolley, J. D.
Open AccessindividualSecondary analysis

Psilocybin-Assisted Group Therapy and Attachment: Observed Reduction in Attachment Anxiety and Influences of Attachment Insecurity on the Psilocybin Experience

This follow-up study (n=18) to Anderson and colleagues (2020) finds that attachment anxiety, but not attachment avoidance, decreased significantly 3 months after psilocybin-assisted group therapy.

Published
Journal
ACS Pharmacology and Translational Science
Authors
Stauffer, C., Anderson, B. T., Ortigo, K. M., Woolley, J. D.
PaywallindividualSecondary analysis

Participant Reports of Mindfulness, Posttraumatic Growth, and Social Connectedness in Psilocybin-Assisted Group Therapy: An Interpretive Phenomenological Analysis

In an interpretive phenomenological analysis of nine gay cisgender men with long-term HIV and clinically significant trauma, psilocybin-assisted group therapy shifted participants from habitual evaluative processing to mindful experiential processing, enabling release of disowned emotions, access to prosocial and self‑transcendent feelings, meaning‑making and posttraumatic growth. These results provide the first empirical indication that adjunctive group‑delivered psilocybin may enhance trauma processing by reinforcing social cohesion, safety and belonging.

Published
Journal
Journal of Humanistic Psychology
Authors
Agin-Liebes, G. I., Ekman, E., Anderson, B. T., Woolley, J. D.
Open Accessindividual

Group psychedelic therapy: empirical estimates of cost-savings and improved access

Analysing 2023 data from MDMA-assisted PTSD and psilocybin-assisted MDD trials, the authors show that group therapy markedly reduces clinician time and costs while expanding potential patient access. Group protocols cut clinician costs by 50.9% for MDMA‑PTSD (≈$3,467 per patient) and 34.7% for psilocybin‑MDD (≈$981), potentially freeing 6,711 and 1,159 FTE clinicians respectively and saving up to $10.3 billion and $2.0 billion in the US over 10 years (3% annual discount).

Published
Journal
Frontiers in Psychiatry
Authors
Marseille, E., Stauffer, C., Agrawal, M., Thambi, P., Roddy, K., Mithoefer, M. C., Bertozzi, S. M., Kahn, J. G.
Open AccessindividualSecondary analysis

Psilocybin-assisted therapy and HIV-related shame

In a pilot clinical trial (N = 12), psilocybin-assisted group therapy produced a large, statistically significant reduction in HIV-related shame from baseline to three-month follow-up. However, two participants experienced a paradoxical worsening of sexual abuse–related shame, highlighting potential risks for trauma-exposed patients.

Published
Journal
Scientific Reports
Authors
Mehtani, N. J., Johnson, M. O., Hendricks, P. S., Mitchell, J., Anderson, B. T.

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