Low-Income Group Psilocybin Assisted Therapy for Depression - Trial NCT06372197
Access comprehensive clinical trial information for NCT06372197 through Pure Global AI's free database. This phase not specified trial is sponsored by Matthew Hicks and is currently Not yet recruiting. The study focuses on Depression. Target enrollment is 24 participants.
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Study Focus
Sponsor & Location
Matthew Hicks
National University of Natural Medicine
Timeline & Enrollment
N/A
Aug 01, 2024
Oct 01, 2024
Primary Outcome
Recruitment Feasibility,Retention Feasibility,Acceptability,Preliminary Safety and Tolerability: incidence and severity of adverse events
Summary
Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness
 and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by
 ballot measure in 2020 and began offering services in 2023. While the program has had many
 successes, a significant problem it faces is affordability and no research to date has
 investigated the therapy in a low-income population.
 
 Psychedelic research in recent decades has used the model of two therapists to one client to
 demonstrate an abundance of caution and safety to regulators, but no evidence has
 demonstrated this model to be safer or more effective than one with less practitioner
 oversight. This feasibility study would be the first investigation of Oregon Psilocybin
 Services as a model of care and among the first few to use a group therapy model. This study
 aims to test the feasibility of the model by assessing recruitment, retention, acceptability
 and safety of the treatment. In addition to an appropriate medical screening and intake the
 following questionnaire data will be collected: the Adverse Childhood Events (ACE)
 questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of
 Consciousness (11-ASC) rating scale, and a survey and structured interview.
 
 Participants will consist of adults in Oregon with an income at or below 200% of the federal
 poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression.
 Participants will be individually screened by a study investigator and placed into groups of
 five to six participants. Treatment will consist of two group preparation sessions, two
 psilocybin sessions, and two group integration sessions. An additional follow-up visit to
 collect further data will take place three months after conclusion of the treatment.
 
 The proposed study will provide valuable information for designing future clinical trials
 investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group
 therapy for depression in low-income populations.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06372197
Non-Device Trial