None listed
Conditions
Brief summary
A double-blind randomised controlled trial in persistent post-concussion symptoms (PPCS). The treatment involves psychotherapy sessions before and after one dose of a psychedelic drug called psilocybin, and a daily self-directed integration program for the 2-week period after the psychedelic session. In addition, the research study also involves several screening procedures, blood collection, neuroimaging and completion of questionnaires and interviews.
Interventions
A double-blind randomised controlled trial testing the addition of a single 25mg dose of psilocybin administered via oral capsule at week 4.
Psychotherapeutic intervention will involve in-person, 2hour-long sessions with a co-therapy team of psilocybin therapists. Three weekly Preparation sessions will be held for three weeks prior to dosing, and four Integration psychotherapy sessions will occur during a six-week period starting the day after the Dosing session. In addition to the in-person in
A double-blind randomised controlled trial testing the addition of a single 25mg dose of psilocybin administered via oral capsule at week 4. Psychotherapeutic intervention will involve in-person, 2hour-long sessions with a co-therapy team of psilocybin therapists. Three weekly Preparation sessions will be held for three weeks prior to dosing, and four Integration psychotherapy sessions will occur during a six-week period starting the day after the Dosing session. In addition to the in-person integration, a High-Intensity Self-Directed Integration program will be completed daily by participants in their own time for approximately 30 minutes to 1 hour for 2 weeks post-dose. The High-Intensity Self-Directed Integration program will involve core topics such as understanding symptoms and recovery, restoring sleep, emotion and stress management, physical reconnection, and exploring meaning and motivation. Adherence in psychotherapy will be assessed by attendance and via review of self-directed integration documents.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
--Be aged 18 to 65 years. --Be able to swallow capsules. --Have a diagnosis of previous mild traumatic brain injury: less than 30 min of loss of consciousness; and less than 24 h of post-traumatic amnesia (PTA). --Have a stable clinician diagnosis of persistent post-concussion symptoms (PPCS) for a minimum of 6 months.
Exclusion criteria
--Have a current or lifetime history of meeting DSM-5 criteria for Schizophrenia, other Psychotic Disorder, Dissociative Identity Disorder, or Bipolar I or II Disorder or other mood disorder with psychotic features. --Have a current or past year history of meeting DSM-5 criteria for alcohol or drug dependence (excluding caffeine and nicotine), if determined by the PI or Study Physician to be incompatible with safe exposure to psilocybin. --Have current serious suicide risk, as determined through psychiatric interview, responses to ColumbiaSuicide Severity Rating Scale (C-SSRS), and clinical judgment of the AP or treating team --Require ongoing concomitant therapy with an excluded medication.
Outcome results
None listed