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

Joshua Woolley

Status and phase: Completed; Phase 1

Conditions: Grief; Distress; Depression

Treatments: Behavioral: Modified brief Supportive Expressive Group Therapy; Drug: Psilocybin

Study type: Interventional

Funder types: Other

Identifiers

NCT02950467

15-17825

Details and patient eligibility

About

The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).

Full description

This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criterion:

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Group therapy plus psilocybin

Experimental group

Description:

Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.

Treatment:

Drug: Psilocybin

Behavioral: Modified brief Supportive Expressive Group Therapy