Clinical trial NCT05468047: Ketamine Therapy Experiential Education Study
Official title: Effects of a Personal Ketamine-assisted Therapy Experience on Clinicians' Therapeutic Competencies Within a Psychedelic-assisted Therapy Training Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Psychedelic Experiences
Therapeutic Alliance
Psychology, Perceptual
Keywords: psychedelic-assisted therapy
therapeutic competency
training program
ketamine
mood disorders
Lead sponsor: Integrative Psychiatry Institute
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an observational study following clinicians enrolled in a psychedelic-assisted therapy training program. It will investigate changes in measures of therapeutic efficacy and competency following those who choose to undergo a personal ketamine-assisted therapy experience and those who do not.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigates the use of low-dose (0.5-0.75 mg/kg; maximum dose of 60 mg regardless of body weight) ketamine hydrochloride injection, USP administered intramuscularly to healthy clinicians as part of an experiential learning practice within a psychedelic-assisted therapy (PAT) training program. The primary objective of this study is to test the hypothesis that competencies required for mental healthcare professionals providing PAT are enhanced by undergoing a single ketamine-assisted therapy experience, as part of a PAT training program.

Primary outcomes of this study are self-reported measures of therapeutic efficacy and competency for providing both general and psychedelic-assisted therapy, measured at baseline and four weeks following an academic in-person retreat with optional ketamine administration. Secondary endpoints include measures of personality and magnitude of perceived mystical experiences. Individual changes in scores across time will be calculated, and differences in therapeutic efficacy and competency between clinician trainees who choose to participate in a personal ketamine-assisted therapy session and those who do not will be assessed.


Eligibility criteria: Inclusion Criteria:

* Age 18-85 years old
* Are proficient in reading and speaking English
* Competent in decision making capacity
* Enrolled in the IPI Psychedelic Assisted Therapy Training Program
* For those being administered ketamine, able and willing to commit to medication dose, attending all study sessions during the In-Person Experiential Training Weekend, and evaluation instruments
* For those being administered ketamine, willing to refrain from using stimulants, anxiolytics during the day of the study session
* May continue but not change psychiatric medications during the course of the study
* Agree to refrain from using stimulants, anxiolytics during the day of the study sessions
* Agree to refrain from alcohol and marijuana for 24 hours before and the day of study sessions
* Agree to refrain from the use of any psychoactive drug during the course of the study
* Willing to be recorded by video and audio for safety purposes only
* Agree to not operate a car or any other heavy equipment for the rest of the day after the ketamine administration
* If necessary, are willing to be contacted via telephone on a daily basis by the therapist or team after each experiential session
* Able to identify one or two caregiver support persons who can drive participant home, be reached by the team, and provide collateral information as needed
* Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned

Exclusion Criteria:

* Unable to provide informed consent
* Anyone currently taking medications contraindicated for ketamine, such as benzodiazepine or lamotrigine
* Anyone deemed at medical screening medically unfit for ketamine exposure including but not limited to:
* prior history of psychotic disorder
* prior history of unstable bipolar disorder
* prior history of personality disorder
* prior history of ketamine use disorder
* active substance use disorder
* untreated migraine headaches
* uncontrolled hypertension
* cardiovascular disease without approval of physician of record
* active or recent suicidal ideation
* pregnancy

Primary outcomes:
measure: Development of Psychotherapists Common Core Questionnaire
timeFrame: 5 weeks
measure: Counseling Self Estimate Inventory
timeFrame: 5 weeks
measure: Psychedelic-Assisted Therapist Self-Efficacy Scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Big-Five Inventory-2
timeFrame: 5 weeks
measure: Mystical Experiences Questionnaire
timeFrame: 3 days
measure: Columbia Suicide Severity Rating Scale- "Baseline" and "Since Last Visit" versions
timeFrame: 5 weeks
Other outcomes:
measure: Demographic questionnaire
timeFrame: 1 day
Locations:
Study officials:
References: