Trial Outcomes & Findings for Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care (NCT NCT04950608)

The study population will include 15 adult patients, 21 years or older, who receive hospice care at home from Care Dimensions hospice in Massachusetts. The study team will screen potential participants by reviewing new admissions and reviewing the current census on a reoccurring basis. For potentially eligible patients, the study team will contact a referent hospice clinician (nurse case manager or physician) to discuss the patient case and confirm the possibility to further the consent process.

If the participant is being treated with psychiatric drugs at the time they are recruited, they will discuss medication tapering with the study psychiatrist and the hospice physician. If needed, the drugs will then be tapered in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the first Experimental Session to avoid the possibility of any drug-drug interaction (the interval will be \>/= 5x the particular drug and active metabolites' half-life).

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care

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.

The FACIT-Pal-14 is a validated 14-item measure of quality of life in palliative care populations. Items assess physical, emotional, social, and functional well-being over the past 7 days using a 5-point Likert scale (0 = not at all to 4 = very much). Scores are summed to produce a total score ranging from 0 to 56, with higher scores reflecting better quality of life. Subscale scores are not typically reported separately, but can be derived if needed by summing relevant items. The measure is widely used in palliative and supportive care research to evaluate patient-centered outcomes.

The PROMIS Pain Interference Scale (8a) is a validated 8-item instrument assessing the extent to which pain hinders engagement in social, emotional, cognitive, and physical activities. Items are rated over the past 7 days on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores range from 8 to 40 and are converted to standardized T-scores (mean = 50, SD = 10) using PROMIS scoring manuals. Higher scores indicate greater interference of pain with daily functioning. The measure is administered only if pain is reported and allows both raw and T-score interpretations to facilitate comparison across studies.

It is a self-report questionnaire consisting of 14 items, and subjects rate how they felt during the previous week on a 4-point Likert scale. The HADS consists of an anxiety and depression subscale (0-21 points each), and total scores can range from 0 to 42. Higher scores indicate more severe depression and anxiety.

The LAP-R Death Acceptance subscale is a validated 8-item measure assessing acceptance of and anxiety about death. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Subscale scores are calculated by summing item responses, yielding a total range of 9 to 56, with higher scores reflecting greater acceptance of death and lower death-related anxiety. The measure is commonly used in palliative care and existential research to evaluate psycho-existential adjustment in serious illness.

The CEQ is a validated 26-item instrument assessing psychologically and somatically difficult aspects of psilocybin experiences. It consists of seven subscales: grief (3 items, range 3-15), fear (6 items, range 6-30), death (3 items, range 3-15), insanity (3 items, range 3-15), isolation (3 items, range 3-15), physical distress (3 items, range 3-15), and paranoia (5 items, range 5-25). Items are rated on a 5-point Likert scale (1 = not at all to 5 = extremely). Subscale scores are computed by summing responses within each domain, with higher scores indicating more challenging experiences. A total score (range 26-130) may also be calculated by summing across all items, providing a global index of psychological challenge.

The PROMIS Social Isolation Scale-6a is a validated 6-item short form that measures perceived social disconnection, including feelings of exclusion, detachment, and lack of belonging. Items are rated on a 5-point Likert scale (1 = never to 5 = always). Raw scores range from 6 to 30 and are converted to standardized T-scores (mean = 50, SD = 10) based on PROMIS scoring guidelines. Higher scores represent greater perceived social isolation. The measure is widely used in psychosocial and palliative care research to assess the impact of illness on social well-being.

The FACIT-Sp-12 is a validated 12-item measure widely used in cancer and palliative care to assess spiritual well-being. It includes three subscales: meaning (4 items, range 0-16), peace (4 items, range 0-16), and faith (4 items, range 0-16). Items are rated on a 5-point Likert scale (0 = not at all to 4 = very much). Subscale scores are summed, and a total score (range 0-48) is obtained by summing across all items. Higher scores indicate greater spiritual well-being. The FACIT-Sp-12 is one of the most commonly used measures of spirituality in serious illness research and has strong psychometric validity.

The DS-II is a validated 16-item self-report measure of demoralization, capturing experiences of disheartenment, helplessness, and loss of meaning. It comprises two subscales: meaning and purpose (8 items, range 0-16) and distress and coping ability (8 items, range 0-16). Items are rated on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Subscale scores are summed, and a total score (range 0-32) is calculated by adding across all items, with higher scores indicating greater demoralization. For Version 5 (V5), items are anchored to the past week rather than the past two weeks in the original version, improving temporal sensitivity in clinical research.

The MEQ-30 is a validated 30-item self-report instrument assessing the phenomenological features of mystical-type experiences induced by psychedelics. It yields four subscales: mystical (15 items, range 0-75), positive mood (6 items, range 0-30), transcendence of time and space (6 items, range 0-30), and ineffability (3 items, range 0-15). Items are rated on a 6-point Likert scale (0 = none to 5 = extreme). Subscale scores are summed, and a total score (range 0-150) is calculated by summing across all items. Higher scores indicate stronger mystical-type experiences, with ≥60% of the maximum possible score on each subscale often used as a criterion for a "complete" mystical experience.