Low-Income Group Psilocybin Assisted Therapy for Depression

Depression Clinical Trial

— LIGPATD  

Official title:

Low-Income Group Psilocybin Assisted Therapy for Depression: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372197
• Other study ID #: LIGPATD
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: National University of Natural Medicine
• Contact: Matthew R Hicks, ND, MS
• Phone: 9714030882
• Email: matthew.hicks[@]nunm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Oregon resident - this is due to the use of telehealth services and licenses of the study clinicians and their scope of practice within the state.

• Age 21 or older - Oregon Psilocybin Services Act sets the minimum eligible age of 21.

• Income 200% or below the Federal Poverty Line - this is the criteria for Oregon Medicaid (OHP).

• DSM-5 diagnosis of Major Depression Disorder.

• Current engagement with psychotherapy - no less than six therapy sessions in the previous six months and an intention to continue seeing their therapist no less than once every two weeks during the study period. This is to ensure participants have adequate psychological support during the study period. Participants must be willing to sign a release of information allowing study clinicians to communicate with their therapists.

• At least six months of stable housing history.

• Able to attend all study events.

• Able to read and speak fluent English.

Exclusion Criteria:

• A personal or family history of an immediate family member of schizophrenia, psychosis of any kind, mania, or hypomania.

• A current prescription for lithium.

• Active suicidal ideations or history of suicide attempts. Passive ideation, such as "I wouldn't mind if I never woke up again" is permissible.

• Uncontrolled hypertension.

• Any form of personality disorder.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Psilocybin
Following Oregon Psilocybin Services (OPS) rules, participants will be placed in cohorts of five to six, which whom they will do two 90-minute preparation session, two psilocybin sessions, and two 90-minute integration sessions. All sessions will be guided by two licensed facilitators.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Hicks

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	Patient-Reported Outcomes Measurement Information System provides metrics for seven health related domains including depression.	Baseline (enrollment), integration #1 (3rd week of treatment), integration #2 (4th week of treatment), and follow-up (3 months post-treatment)
Other	Altered State of Consciousness rating scale (11-ASC)	Provides a rating of intensity of altered state experiences across eleven domains.	At the end of both psilocybin sessions (week 3 and week 4).
Primary	Recruitment Feasibility	Determine the recruitment rate (number of participants enrolled compared to those approached) for low-income adults with depression into a group psilocybin-assisted therapy program.	Beginning at study approval and funding through full enrollment, up to 18 months
Primary	Retention Feasibility	Evaluate the participant retention rate throughout the study, including psilocybin sessions and follow-up assessments.	From participant enrollment through follow-up, up to 18 months
Primary	Acceptability	Assess participant satisfaction with the group psilocybin-assisted therapy format through qualitative interviews and survey, including "On a scale of 0 to 5, zero being very dissatisfied and 5 being very satisfied, how would you rate your satisfaction with the treatment overall?"	Assessed at the three month follow-up visit after completion of intervention
Primary	Preliminary Safety and Tolerability: incidence and severity of adverse events	The incidence and severity of adverse events associated with psilocybin administration in a group setting will be documented and reported on to assess safety and tolerability.	Through study completion, up to 18 months