Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder
This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD). Participants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach. The primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment. This pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.
• Age 21-65 years.
• Diagnosis of post-traumatic stress disorder (PTSD) according to DSM-5 criteria, as assessed by CAPS-5.
• At least 1 year since the traumatic event.
• Moderate or greater PTSD severity (CAPS-5 score ≥ 25).
• Ability to provide written informed consent.
• Ability to read, write, speak, and understand Hebrew.
• Prior trauma-focused psychotherapy.
• Medically healthy at screening, as determined by a study physician, including:
‣ No exclusionary medical conditions.
⁃ Resting blood pressure between 90/60 and 150/90 mmHg and heart rate between 45-100 bpm.
⁃ Normal laboratory results (including liver function, renal function, and electrolytes).