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.
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
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Group therapy + psilocybin
experimentalModified brief Supportive-Expressive Group Therapy (ten twice-weekly sessions) plus one individual oral psilocybin session.
Interventions
- Psilocybinvia Oral• single dose
One individual oral psilocybin treatment session; dose not stated in registry fragment.
- Compoundvia Other• ten sessions
Modified brief Supportive-Expressive Group Therapy: manualised, twice-weekly group sessions
Participants
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 Details
- StatusCompleted
- PhasePhase I
- Typeinterventional
- DesignNon-randomized
- Target Enrollment30 participants
- TimelineStart: 2018-01-05End: 2019-12-31
- Compound
- Topic