Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04950608 | Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care | PHASE2 | COMPLETED | 15 | — | — | Mar 9, 2022 | Dec 31, 2025 | Feb 17, 2026 | 1 | United States |
This measurement will assess enrollment feasibility based on the screening log.
Number of screened hospice patients who met pre-eligibility criteria and were approached for consent
This measurement will assess enrollment feasibility based on the screening log.
This measurement will assess enrollment feasibility based on the screening log.
Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5)
The RRPQ-R is a validated 23-item instrument designed to assess participants' experiences and perceptions of research participation. It comprises five subscales: participation (7 items, range 7-35), personal benefit (5 items, range 5-25), emotional reactions (6 items, range 6-30), perceived drawbacks (3 items, range 3-15), and global evaluation (2 items, range 2-10). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores on participation, personal benefit, and global evaluation indicate more positive perceptions, while higher scores on emotional reactions and perceived drawbacks reflect greater negative emotional or practical impact. A total score can be calculated by summing across all items (range 23-115), with higher scores reflecting more favorable overall experiences of research participation.
| Arm | Type | Description |
|---|---|---|
| PATH | EXPERIMENTAL | The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
| Name | Type | Description |
|---|---|---|
| Psilocybin | DRUG | Oral, single administration, dosage 25 mg orally |
| Psychotherapy | BEHAVIORAL | The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
Inclusion Criteria: * Patients enrolled in hospice care at home * Age ≥ 21 years. * Any terminal illness with respect of exclusion criteria * Palliative Performance Scale (PPS) ≥ 50 % (see Appendix A) * Moderate-to-severe demoralization as measured by Demoralization Scale-II ≥ 8 * Significant other...