The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PSaC.
AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PSaC.
Participants will be asked to:
* Complete a 2-part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\]) * Complete 5 weekly sessions of Acceptance and commitment therapy (ACT) * Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
Individuals of all sexes, gender identities, and ethnicities
Ages 18 to 65 years at the time of screening
Diagnosis of concussion based on the 2024 ACRM criteria
Meet ICD-10 criteria for PSaC for at least 3-months to a maximum of 5 years
None
Parallel
Psilocybin
DrugSee treatment arm description.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety will be determined based on adverse reactions and symptom reporting (categorized as mild, moderate, and severe)
Study protocol efficacy
The primary efficacy outcome is the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).The RPQ assesses the severity of 16 commonly experienced PSaC symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PSaC symptom burden.
Study protocol feasibility
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol)
Montgomery-Asberg Depression Rating Scale Self report (MADRS-S)
The MADRS is a 10-item assessment of depressive symptoms using a recall period of the past 7 days. Total scores range from 0-60, with higher scores indicating greater depression.
Generalized Anxiety Disorder-7 (GAD-7).
The GAD-7 is a 7-item tool which assess anxiety. Individuals rate how often they have been bothered by seven listed problems and score their responses from 0 ("not at all") to 3 ("nearly every day"). Total scores for anxiety severity are: 0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21: severe anxiety.
Sleep and Concussion Questionnaire (SCQ)
During the SCQ-initial, participants use the timeframe of the 6-months prior to the concussion, and since the concussion. The SCQ-follow-up will have a recall period of since the most recent SCQ was completed. Total scores of 0-7 indicate no clinically significant change; 8-15: subclinical change; 16-22: clinical changes of moderate severity; 23-36: clinically severe changes in sleep or wakefulness.
Headache Impact Test (HIT-6).
This 6-item tool assesses how headache intensity impacts daily life functioning. Headache intensity and frequency are measured from "never" to "always", with greater scores indicating greater impact on daily life function due to headache. Total scores of 49 or less indicate headaches have little to no impact on daily life; 50-55: headaches have some impact on life; 56-59: headaches have substantial impact on life; 60 or more: headaches have severe impact on life.
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University of Calgary
Lead sponsor
University of British Columbia
Collaborator
