Cancer-related Problem/Condition, Cancer Terminal, Demoralization, Hospice, Psilocybin, Psychotherapy, Terminal Cancer, Terminal Illness
Conditions
Keywords
Hospice, Psilocybin, Demoralization, Terminal Illness, Cancer related terminal illness, psychotherapy, Terminal Cancer, Cancer Terminal
Brief summary
The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care. -The name of the study drug involved in this study is Psilocybin
Detailed description
The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice care, in order to test its safety in people with terminal illness who experience demoralization, and to study how well it works to lessen symptoms of psychological and existential distress. * This research study involves a combined drug and psychotherapeutic (talk therapy) intervention. 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 with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions * The name of the study drug involved in this study is Psilocybin. Psilocybin is a naturally occurring psychedelic drug produced by more than 200 species of mushrooms, which is manufactured for medical use to control potency and purity. * Participants will be followed for up to 24 weeks (approximately 6 months) after the study treatment. It is expected that about 15 people will take part in this research study. * This research study is a Feasibility Study, which mean it is the first time investigators are examining psilocybin-assisted therapy in the context of hospice care. Psilocybin is an "Investigational" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, the FDA has granted psilocybin the status of "breakthrough therapy" in the treatment of depression and the investigators have permission from the FDA to use this drug in this research study.
Interventions
DRUGPsilocybin
Oral, single administration, dosage 25 mg orally
BEHAVIORALPsychotherapy
The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions
Sponsors
Yvan Beaussant, MD, MSci
Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants
Usona Institute
Carey and Claudia Turnbull Family Foundation
Heffter Research Institute
George Sarlo Foundation
RiverStyx Foundation
Council on Spiritual Practices Fund at the San Francisco Foundation
Nikean Foundation
Jack Smith
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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 or other caregiver present at home the night of study drug administration * No driving for 24 hours following study drug administration. * English proficiency * Ability to understand and the willingness to sign a written informed consent document. * Psilocybin is very likely to have no genotoxic effects. One study that directly focused on the mutagenic potential of psilocybin did not found this type of toxicity. However, due to the lack of clinical and non-clinical studies on the effects of psilocybin on the developing human fetus, women and men of child-bearing potential and who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Screened Per Study Period | Through study completion, through 22 months | This measurement will assess enrollment feasibility based on the screening log. |
| Eligible Population | Through study completion, over 22 months | Number of screened hospice patients who met pre-eligibility criteria and were approached for consent |
| Number of Participants Enrolled Over Study Period | Through study completion, over 22 months | This measurement will assess enrollment feasibility based on the screening log. |
| Average Time From Screening to Enrollment | From date of screening until the date of enrollment, assessed up to 12 months | This measurement will assess enrollment feasibility based on the screening log. |
| Number of Therapy Sessions Completed by Enrolled Participants | Through study completion, a period of 22 months | Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5) |
| Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR) | At Week 1 post dosing session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | At Baseline, and weeks 1, 3, and 7 | 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. |
| Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | At Baseline, and weeks 1, 3, and 7 | 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. |
| Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | At Baseline, and weeks 1, 3, and 7 | 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. |
| Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score | At Baseline, and weeks 1, 3, and 7 | 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. |
| Challenging Experience Questionnaire (CEQ) Score | Immediately after the intervention, at the end of the dosing day | 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. |
| Change in Social Isolation Scale (SIS) Score | At Baseline, and weeks 1, 3, and 7 | 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. |
| Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | At Baseline, and weeks 1, 3, and 7 | 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. |
| Change in Demoralization Scale (DS-II) | At Baseline, and weeks 1, 3, and 7 | 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. |
| Mystical Experience Questionnaire (MEQ-30) | Immediately after the intervention, at the end of the dosing day | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYvan Beaussant, MD
Dana-Farber Cancer Institute
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| PATH 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
Psilocybin: Oral, single administration, dosage 25 mg orally
Psychotherapy: The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | PATH |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Baseline Palliative Performance Scale | 62 units on a scale STANDARD_DEVIATION 8.6 |
| Diagnosis Breast Cancer | 1 Participants |
| Diagnosis Chronic lung allograft rejection | 1 Participants |
| Diagnosis Gastro-intestinal cancers | 9 Participants |
| Diagnosis GYN cancers | 1 Participants |
| Diagnosis Light chain amyloidosis | 1 Participants |
| Diagnosis Pulmonary fibrosis | 2 Participants |
| Education 11th Grade or less | 1 Participants |
| Education 2 years of college /technical school | 3 Participants |
| Education College graduate (BS or BA) | 5 Participants |
| Education Doctorate/Medical degree/Law degree | 2 Participants |
| Education High school graduate or GED | 2 Participants |
| Education Master's degree | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Relationship Status Divorced/Separated | 2 Participants |
| Relationship Status Married /long-term partner | 7 Participants |
| Relationship Status Single, never married | 3 Participants |
| Relationship Status Widowed/Loss of long-term partner | 3 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 15 |
| other Total, other adverse events | 13 / 15 |
| serious Total, serious adverse events | 10 / 15 |
Outcome results
Primary
Average Time From Screening to Enrollment
This measurement will assess enrollment feasibility based on the screening log.
Time frame: From date of screening until the date of enrollment, assessed up to 12 months
Population: Participants who were enrolled in the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Psilocybin- Single Arm | Average Time From Screening to Enrollment | 36.6 days |
Primary
Eligible Population
Number of screened hospice patients who met pre-eligibility criteria and were approached for consent
Time frame: Through study completion, over 22 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Psilocybin- Single Arm | Eligible Population | 66 Participants |
Primary
Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR)
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.
Time frame: At Week 1 post dosing session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psilocybin- Single Arm | Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR) | 90.1 score on a scale | Standard Deviation 11.98 |
Primary
Number of Participants Enrolled Over Study Period
This measurement will assess enrollment feasibility based on the screening log.
Time frame: Through study completion, over 22 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Psilocybin- Single Arm | Number of Participants Enrolled Over Study Period | 15 participants |
Primary
Number of Participants Screened Per Study Period
This measurement will assess enrollment feasibility based on the screening log.
Time frame: Through study completion, through 22 months
Population: Home hospice population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Psilocybin- Single Arm | Number of Participants Screened Per Study Period | 4607 participants |
Primary
Number of Therapy Sessions Completed by Enrolled Participants
Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5)
Time frame: Through study completion, a period of 22 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Psilocybin- Single Arm | Number of Therapy Sessions Completed by Enrolled Participants | All Visits Completed | 9 Participants |
| Psilocybin- Single Arm | Number of Therapy Sessions Completed by Enrolled Participants | V1 through V4 completed | 1 Participants |
| Psilocybin- Single Arm | Number of Therapy Sessions Completed by Enrolled Participants | V1 and V2 completed | 3 Participants |
| Psilocybin- Single Arm | Number of Therapy Sessions Completed by Enrolled Participants | V1 completed | 1 Participants |
| Psilocybin- Single Arm | Number of Therapy Sessions Completed by Enrolled Participants | No therapy session completed | 1 Participants |
Secondary
Challenging Experience Questionnaire (CEQ) Score
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.
Time frame: Immediately after the intervention, at the end of the dosing day
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psilocybin- Single Arm | Challenging Experience Questionnaire (CEQ) Score | 36.6 score on a scale | Standard Deviation 20.8 |
Secondary
Change in Demoralization Scale (DS-II)
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Demoralization Scale (DS-II) | Baseline | 17.3 score on a scale |
| Psilocybin- Single Arm | Change in Demoralization Scale (DS-II) | Week 1 (V5) | 12 score on a scale |
| Psilocybin- Single Arm | Change in Demoralization Scale (DS-II) | Week 3 (V6a) | 8.5 score on a scale |
| Psilocybin- Single Arm | Change in Demoralization Scale (DS-II) | Week 7 (V6b) | 14.6 score on a scale |
Secondary
Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14)
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | Baseline | 26.5 score on a scale |
| Psilocybin- Single Arm | Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | Week 1 (V5) | 26.9 score on a scale |
| Psilocybin- Single Arm | Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | Week 3 (V6a) | 30.3 score on a scale |
| Psilocybin- Single Arm | Change in Global Quality Life Score as Assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14) | Week 7 (V6b) | 30.8 score on a scale |
Secondary
Change in Hospital Anxiety and Depression Scale (HADS A and D) Score
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-A: Week 1 (V5) | 9 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-A: Baseline | 9.7 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-A: Week 3 (V6a) | 5.67 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-A: Week 7 (V6b) | 8 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-D: Baseline | 10.1 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-D: Week 1 (V5) | 9.67 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-D: Week 3 (V6a) | 7.83 score on a scale |
| Psilocybin- Single Arm | Change in Hospital Anxiety and Depression Scale (HADS A and D) Score | HADS-D: Week 7 (V6b) | 8.2 score on a scale |
Secondary
Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score | Baseline | 32.3 score on a scale |
| Psilocybin- Single Arm | Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score | Week 1 (V5) | 35 score on a scale |
| Psilocybin- Single Arm | Change in Life Attitude Profile - Revised, Death Acceptance Subscale (LAP-R) Score | Week 3 (V6a) | 34.5 score on a scale |
Secondary
Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS)
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | Baseline | 24.1 score on a scale |
| Psilocybin- Single Arm | Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | Week 1 (V5) | 24.4 score on a scale |
| Psilocybin- Single Arm | Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | Week 3 (V6a) | 19.7 score on a scale |
| Psilocybin- Single Arm | Change in Physical Domain Score as Assessed by PROMIS Pain Interference Scale (PIS) | Week 7 (V6b) | 26.5 score on a scale |
Secondary
Change in Social Isolation Scale (SIS) Score
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Social Isolation Scale (SIS) Score | Baseline | 14.9 score on a scale |
| Psilocybin- Single Arm | Change in Social Isolation Scale (SIS) Score | Week 1 (V5) | 15.6 score on a scale |
| Psilocybin- Single Arm | Change in Social Isolation Scale (SIS) Score | Week 3 (V6a) | 13.5 score on a scale |
| Psilocybin- Single Arm | Change in Social Isolation Scale (SIS) Score | Week 7 (V6b) | 13.4 score on a scale |
Secondary
Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12)
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.
Time frame: At Baseline, and weeks 1, 3, and 7
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Psilocybin- Single Arm | Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | Baseline | 22.3 score on a scale |
| Psilocybin- Single Arm | Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | Week 1 (V5) | 26.7 score on a scale |
| Psilocybin- Single Arm | Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | Week 3 (V6a) | 30.3 score on a scale |
| Psilocybin- Single Arm | Change in Spiritual Domain Score as Assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12) | Week 7 (V6b) | 29.4 score on a scale |
Secondary
Mystical Experience Questionnaire (MEQ-30)
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.
Time frame: Immediately after the intervention, at the end of the dosing day
Population: Treated participants who completed the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psilocybin- Single Arm | Mystical Experience Questionnaire (MEQ-30) | 84.1 score on a scale | Standard Deviation 34.47 |