Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372197
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-10
Brief Title:
Low-Income Group Psilocybin Assisted Therapy for Depression
Sponsor:
Matthew Hicks
Organization:
National University of Natural Medicine
Study Overview
Official Title:
Low-Income Group Psilocybin Assisted Therapy for Depression A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIGPATD
Brief Summary:
Due to psilocybin-assisted therapys 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 CredibilityExpectancy 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
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 CredibilityExpectancy 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None