We aim to investigate the effects of a single dose of psilocybin, delivered in the context of pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the coronavirus disease of 2019 (COVID) pandemic.
Topic Depression
Anxiety
Compound Psilocybin
Placebo
Country United States of America
Visit trial
Status
Recruiting
Results Published
Start date
15 December 2021
End date
01 December 2023
Chance of happening
89%
Phase
Phase I
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
30
Sex
All
Age
18- 99
Therapy
No
Trial Details
Aim 1: To assess short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of depression experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 1.1: Compared to active placebo, PAP will result in short term improvement in symptoms of depression 1 day and 1 week after the psilocybin dose session. Hypothesis 1.2: Compared to active placebo, PAP will result in longer term improvement of symptoms of depression 4 weeks after the medication dosing session. The primary outcome will be a comparison between the psilocybin 25 mg vs control groups of a combination of depression symptoms measured at 4 weeks post medication dose session. 1.1.2. Aim 2: To explore short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of burnout experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 2.1: Compared to active placebo, PAP will result in short term improvement in symptoms of burnout 1 day and 1 week after the psilocybin dose session.NCT Number NCT05163496
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
PTSD Checklist for DSM-5
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item instrument that can be used to make a provisional diagnosis of PTSD based on DSM-5 criteria.
Beck Depression Inventory
The Beck Depression Inventory (BDI) contains 21 self-report items, completed using a multiple-choice format. Scores range from 0-63 with higher scores associated with more severe depression.