Low-Income Group Psilocybin Assisted Therapy for Depression (LIGPATD)

This open-label feasibility study (n=24) will investigate the potential of group psilocybin-assisted therapy for depression in low-income adults in Oregon.

The study aims to assess recruitment, retention, acceptability, and safety of the treatment model. Participants, aged 21 or older, with a DSM-5 diagnosis of Major Depression Disorder and income at or below 200% of the Federal Poverty Line, will undergo two group preparation sessions, two psilocybin sessions, and two group integration sessions.

Led by Matthew Hicks from the National University of Natural Medicine, the study will follow the Oregon Psilocybin Services (OPS) rules, with participants placed in cohorts of five to six.

The primary outcome measures include recruitment and retention feasibility, acceptability, and preliminary safety and tolerability of the therapy. Additional measures, such as the PROMIS-29 and Altered State of Consciousness rating scale, will also be assessed.

Recruitment is expected to begin in August 2024, with completion anticipated by October 2024. The study will provide valuable insights into the potential of psilocybin-assisted group therapy for depression in low-income populations.

Topic Depression Safety
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2024
End date 31 October 2024
Phase Not Applicable
Design Open
Type Interventional
Generation First
Participants 24
Sex All
Age 21- 99
Therapy Yes

Trial Details

This feasibility study aims to assess the potential of psilocybin-assisted group therapy for depression in low-income adults in Oregon, addressing a gap in research on affordability and inclusivity within psychedelic therapy. With the Oregon Psilocybin Services Act in place since 2023, this study pioneers the exploration of this model of care and group therapy approach, evaluating its feasibility through recruitment, retention, acceptability, and safety assessments. Participants, meeting DSM-5 criteria for major depression and residing at or below 200% of the federal poverty level, will undergo screening and be grouped for treatment sessions, including preparation, psilocybin sessions, and integration sessions. By collecting data on various measures including Adverse Childhood Events, Credibility/Expectancy, PROMIS-29, and Altered States of Consciousness, this study aims to inform future clinical trials on the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted therapy in low-income populations.

NCT Number NCT06372197

Data attribution

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