Approval Probability
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Psilocybin-assisted Psychotherapy · 1 trial · 1 indication
The last month CAPS-5-R is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event and time since exposure, and rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The CAPS-5-R will be administered by a study independent CAPS-5-R rater.
Comprehensive qualitative information about participants' evaluation of the feasibility, acceptability and efficacy of psilocybin-assisted psychotherapy for PTSD will be collected through a semi-structured interview.
A modified 10-item version of the Treatment Acceptability and Adherence Scale (TAAS-M) will be used to describe acceptability and adherence to psilocybin-assisted psychotherapy.
The feasibility of participant screening and study retention will be assessed by documenting the number and proportion of participants who fail screening, the number and proportion of enrolled participants who discontinue the intervention, and the reasons for screen failure and discontinuation. All measures will be summarized descriptively.
Concomitant medication use during study participation will be recorded.
The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial.
Severity, incidence and frequency of AEs and serious adverse events (SAEs).
Systiloc and diastolic blood pressure (mmHg) will be monitored.
Heart rate (beats per minute) will be monitored.
Body temperature (°C) will be monitored.
| Arm | Type | Description |
|---|---|---|
| Psilocybin-assisted psychotherapy | EXPERIMENTAL | Psilocybin-assisted psychotherapy |
| Name | Type | Description |
|---|---|---|
| Psilocybin-assisted Psychotherapy | DRUG | Two psilocybin sessions (15 mg psilocybin in the first session; 25 mg psilocybin in the second session) embedded in a psychotherapeutic framework with three preparatory sessions and six integrative sessions. |
Inclusion Criteria: * Are between 18 and 70 years old. * Able to provide written informed consent. * Fluent in speaking and reading Dutch. * Is a veteran of the Dutch Armed Forces. * Able to swallow pills. * Have a body mass index (kg/m2) of \>18.0. * Meet DSM-5 criteria for current PTSD. * Meet cr...