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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine administration | Experimental | These individuals will be provided a personal ketamine-assisted therapy experience as part of an in-person training weekend within a psychedelic-assisted training program. |
|
| No ketamine administration | No Intervention | These individuals will undergo the same psychedelic-assisted training program as those who receive the ketamine experience and will attend the same in-person training weekend; however, these individuals have opted out of ketamine administration by choice or due to contraindication and will not participate in the personal experience. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine hydrochloride injection | Drug | Individuals will be administered a single dose of sub-anesthetic (0.5-0.75 mg/kg; maximum dose of 60 mg regardless of body weight) ketamine hydrochloride injection intramuscularly as part of a ketamine-assisted therapy experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Psychotherapists Common Core Questionnaire | Scale measuring perceived determinants of professional development as a therapist; this study uses Subscales 8 (21 questions) and 10-1 (1 question) of the DPCCQ. This multi-dimensional measure of therapist development uses questions based on a Likert scale that range from 0 (worst outcome) to 5 (best outcome), -3 (worst outcome) to 3 (best outcome), and 1 (worst outcome) to 6 (best outcome). | 5 weeks |
| Counseling Self Estimate Inventory | Scale measuring self-reported measures of general counseling efficacy; Likert scale ranging from 1 (worst outcome) to 6 (best outcome) for each of 37 items. | 5 weeks |
| Psychedelic-Assisted Therapist Self-Efficacy Scale | Scale designed to assess psychedelic-assisted therapy-related competencies as defined in the IPI PAT Training Program; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 45 items. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Big-Five Inventory-2 | Self reported personality questionnaire; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 60 items. | 5 weeks |
| Mystical Experiences Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic questionnaire | Self-reported baseline demographic information about participants that may be associated with outcomes | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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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.
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Self-reported scale that assesses ketamine-associated mystical experience and its impact on personal and professional life; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 30 items.
| 3 days |
| Columbia Suicide Severity Rating Scale- "Baseline" and "Since Last Visit" versions | Self-reported assessment of suicidal ideation and behavior; Yes or No questions assess suicidal ideation and behavior, while Likert scales ranging from 0 (best outcome) to 5 (worst outcome), 1 (best outcome) to 5 (best outcome), or 0 (best outcome) to 2 (worst outcome) for 7 items assess severity. | 5 weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |