Depression, Distress, Grief
Conditions
Keywords
HIV/AIDS, Demoralization, Psilocybin, Group therapy
Brief summary
The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).
Detailed description
This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.
Interventions
DRUGPsilocybin
One individual oral psilocybin treatment session
BEHAVIORALModified brief Supportive Expressive Group Therapy
Ten sessions of twice-weekly manualized group therapy
Sponsors
Heffter Research Institute
RiverStyx Foundation
Usona Institute
Stupski Foundation
Joshua Woolley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criterion: * Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.
Exclusion criteria
* A physical, neurological or cognitive condition that makes participating in the study unsafe or unfeasible. * Regular psychotropic medication use. * Personal or family history of serious mental illness. * Severe depression requiring immediate standard-of-care treatment. * Exclusion by the clinical judgment of the study investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 | Enrollment to 3-month follow up, about 5 months | Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry. Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians. |
| Subject Recruitment and Retention | Duration of study, about 24 months | Two therapy groups of at least 4 subjects each will complete the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome. |
| Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up | Baseline and 3-month follow-up | Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome. |
| Change From Baseline in Demoralization Scale-II at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome. |
| Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up | Baseline and 3-month follow-up | Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome. |
| Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug | Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication. | The Group Questionnaire is a self-report measure with three sub-scales that measure Positive Bonding, Positive Working and Negative Relationship dimensions of the relationships at 3 levels: between group members, between group members and group therapists, and between group members and the group as a whole. Each subscale score is calculated by summation of the ratings across all three levels for each subscale. Positive Bonding scores range from 13 to 91 with higher scores indicating a better outcome. Positive Working scores range 8 to 56 with higher scores indicating a better outcome. Negative Relationship scores range 9 to 63 with higher scores indicating worse outcomes. |
| Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome. |
| Change From Baseline in Demoralization Scale-II at 3-month Follow-up | Baseline and 3-month follow-up | Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up | Baseline and 3-month follow-up | Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. |
| Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. |
| Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up | Baseline and 3-month follow-up | Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. |
| Change From Baseline in PTSD Checklist 5 at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. |
| Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up | Baseline and 3-month follow-up | Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes. |
| Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome. |
| Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up | Baseline and 3-month follow-up | Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome. |
| Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes. |
| Change From Baseline in PTSD Checklist 5 at 3-month Follow-up | Baseline and 3-month follow-up | PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. |
| Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. |
| Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up | Baseline and 3-month follow-up | State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. |
| Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. |
| Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up | Baseline and 3-month follow-up | Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome. |
| Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome. |
| Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up | Baseline and 3-month follow-up | HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome. |
| Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment | Baseline and end-of-treatment (7 weeks duration) | Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the community 17 July 2017 to 24 August 2018 in the San Francisco Bay Area.
Pre-assignment details
91 study candidates were screened over the phone, of which 37 were eligible for in-person enrollment evaluations, of which 30 attended an in-person enrollment evaluation and were consented to the study. 18 candidates were found to be eligible for the study, all of whom enrolled in the trial and initiated treatment.
Participants by arm
| Arm | Count |
|---|---|
| Group Therapy Plus Psilocybin Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.
Psilocybin: One individual oral psilocybin treatment session
Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Group Therapy Plus Psilocybin |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 4.4 |
| Annual income <$50,000 | 10 Participants |
| Annual income ≥$50,000 | 8 Participants |
| Civil status Divorced/Separated | 2 Participants |
| Civil status Married/Partnered | 8 Participants |
| Civil status Single | 8 Participants |
| Education College or more | 13 Participants |
| Education Less than college | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lifetime: People close to you who have died | 17.5 people |
| Lifetime: Times used a classic psychedelic | 5 instances |
| Palliative Performance Scale v2.0 | 92.8 units on a scale STANDARD_DEVIATION 11.3 |
| Patients meeting current SCID-5/SCID-5-PD diagnosis Borderline personality disorder | 3 participants |
| Patients meeting current SCID-5/SCID-5-PD diagnosis Generalized anxiety disorder | 7 participants |
| Patients meeting current SCID-5/SCID-5-PD diagnosis Major depressive disorder | 5 participants |
| Patients meeting current SCID-5/SCID-5-PD diagnosis No SCID-5/SCID-5-PD diagnosis (of those assessed) | 9 participants |
| Patients meeting current SCID-5/SCID-5-PD diagnosis Panic disorder | 3 participants |
| PTSD Checklist-5 (PCL-5) >33/80 | 3 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 | 3 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 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
| Year of HIV/AIDS/GRID Diagnosis | 1988 years STANDARD_DEVIATION 4.8 |
| Years since last used a classic psychedelic | 20 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 18 / 18 |
| serious Total, serious adverse events | 3 / 18 |
Outcome results
Primary
Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
Full details of adverse event data are in the Adverse Events module of this ClinicalTrials.gov entry. Adverse events were assessed at every study visit by patient interview. During medication visits, adverse events were also assess by vitals sign monitoring, patient self-report, and adverse events observed by clinicians.
Time frame: Enrollment to 3-month follow up, about 5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group Therapy Plus Psilocybin | Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 | 18 Participants |
Primary
Subject Recruitment and Retention
Two therapy groups of at least 4 subjects each will complete the study
Time frame: Duration of study, about 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Subject Recruitment and Retention | Enrolled | 18 Participants |
| Group Therapy Plus Psilocybin | Subject Recruitment and Retention | Completed Safety Assessment at End-of-treatment | 18 Participants |
| Group Therapy Plus Psilocybin | Subject Recruitment and Retention | Completed Safety Assessment at 3-month follow-up | 18 Participants |
Secondary
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up | -8.89 units on a scale | Standard Deviation 12.02 |
Secondary
Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment | -8.94 units on a scale | Standard Deviation 14.73 |
Secondary
Change From Baseline in Demoralization Scale-II at 3-month Follow-up
Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.
Time frame: Baseline and 3-month follow-up
Population: Intent-to-treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Demoralization Scale-II at 3-month Follow-up | -5.78 units on a scale | Standard Deviation 6.01 |
Secondary
Change From Baseline in Demoralization Scale-II at End-of-treatment
Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Demoralization Scale-II at End-of-treatment | -6.67 units on a scale | Standard Deviation 6.5 |
Secondary
Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up | -7.06 units on a scale | Standard Deviation 7.61 |
Secondary
Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment | -6.22 units on a scale | Standard Deviation 6.74 |
Secondary
Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
The Group Questionnaire is a self-report measure with three sub-scales that measure Positive Bonding, Positive Working and Negative Relationship dimensions of the relationships at 3 levels: between group members, between group members and group therapists, and between group members and the group as a whole. Each subscale score is calculated by summation of the ratings across all three levels for each subscale. Positive Bonding scores range from 13 to 91 with higher scores indicating a better outcome. Positive Working scores range 8 to 56 with higher scores indicating a better outcome. Negative Relationship scores range 9 to 63 with higher scores indicating worse outcomes.
Time frame: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.
Population: intent-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Therapy Plus Psilocybin | Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug | Positive Bonding (Overall) | 2.61 score on a scale | Standard Deviation 4.77 |
| Group Therapy Plus Psilocybin | Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug | Positive Working (Overall) | 1.87 score on a scale | Standard Deviation 7.31 |
| Group Therapy Plus Psilocybin | Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug | Negative Relationship (Overall) | -0.69 score on a scale | Standard Deviation 2.7 |
Other Pre-specified
Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up
Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat (one participant did not use antiretrovirals)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up | -0.94 units on a scale | Standard Deviation 2.38 |
Other Pre-specified
Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment
Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat (one participant did not use antiretrovirals)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment | -0.71 units on a scale | Standard Deviation 4 |
Other Pre-specified
Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up
Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up | -3.33 units on a scale | Standard Deviation 7.66 |
Other Pre-specified
Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment
Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment | -0.78 units on a scale | Standard Deviation 8.86 |
Other Pre-specified
Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up
Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up | -0.06 units on a scale | Standard Deviation 6.3 |
Other Pre-specified
Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment
Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment | -2.72 units on a scale | Standard Deviation 6.85 |
Other Pre-specified
Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up
HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat (data capture error for 6 participants)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up | -4.25 units on a scale | Standard Deviation 4.47 |
Other Pre-specified
Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment
HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment | -5.83 units on a scale | Standard Deviation 5.23 |
Other Pre-specified
Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment
Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment | 2.0 units on a scale | Standard Deviation 1.91 |
Other Pre-specified
Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up
Self-report quality of life measure. Only item A) Overall quality of life. Minimum = 0 (Very bad). Maximum = 10 (Excellent). Higher scores mean better outcomes.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up | 0.94 units on a scale | Standard Deviation 2.44 |
Other Pre-specified
Change From Baseline in PTSD Checklist 5 at 3-month Follow-up
PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in PTSD Checklist 5 at 3-month Follow-up | -7.11 units on a scale | Standard Deviation 13.81 |
Other Pre-specified
Change From Baseline in PTSD Checklist 5 at End-of-treatment
PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in PTSD Checklist 5 at End-of-treatment | -9 units on a scale | Standard Deviation 11.47 |
Other Pre-specified
Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up
State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up | 1.06 units on a scale | Standard Deviation 13.23 |
Other Pre-specified
Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment
State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment | -5.56 units on a scale | Standard Deviation 9.04 |
Other Pre-specified
Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up
Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time frame: Baseline and 3-month follow-up
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up | -3.39 units on a scale | Standard Deviation 10.55 |
Other Pre-specified
Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment
Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time frame: Baseline and end-of-treatment (7 weeks duration)
Population: intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Therapy Plus Psilocybin | Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment | -6.06 units on a scale | Standard Deviation 5.5 |