Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

• Sponsor: Joshua Woolley (Other)
• Overall Status: Completed
• CT.gov ID: NCT02950467
• Collaborator: Heffter Research Institute (Other), River Styx Foundation (Other), Usona Institute (Other), Stupski Foundation (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Distress; Depression; Grief	Drug: Psilocybin; Behavioral: Modified brief Supportive Expressive Group Therapy	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
• Actual Study Start Date: Jan 5, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Psilocybin; One individual oral psilocybin treatment session; Other Names: 4-phosphoryloxy-N,N-dimethyltryptamine Indocybin ; Behavioral: Modified brief Supportive Expressive Group Therapy; Ten sessions of twice-weekly manualized group therapy

Outcome Measures

Primary Outcome Measures

1. 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.

2. Subject Recruitment and Retention [Duration of study, about 24 months]

   Two therapy groups of at least 4 subjects each will complete the study

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Other Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• Joshua Woolley
• Heffter Research Institute
• River Styx Foundation
• Usona Institute
• Stupski Foundation

Investigators

• Principal Investigator: Joshua Woolley, MD,PhD, University of California, San Francisco
• Study Director: Brian Anderson, MD,MSc, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: Final protocol - Feb 20, 2019
• Informed Consent Form: Final ICF - Feb 20, 2019
• Informed Consent Form: ICF for Cohorts 2 and 3 - Apr 17, 2018
• Study Protocol and Statistical Analysis Plan: Pre-modifications related to enrollment exceptions - Apr 17, 2018

More Information

Publications

None provided.

• Responsible Party: Joshua Woolley, Assistant Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02950467
• Other Study ID Numbers: 15-17825
• First Posted: Nov 1, 2016
• Last Update Posted: Jan 7, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joshua Woolley, Assistant Professor, University of California, San Francisco: HIV/AIDS; Demoralization; Psilocybin; Group therapy
• Additional relevant MeSH terms: Depression; Psilocybin; N,N-Dimethyltryptamine

Study Results

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 Detail	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.

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Period Title: Open-label Treatment
STARTED	18
COMPLETED	18
NOT COMPLETED	0
Period Title: Open-label Treatment
STARTED	18
COMPLETED	18
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Overall Participants	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (4.4)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	18 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.6%
Not Hispanic or Latino	17 94.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5.6%
White	14 77.8%
More than one race	3 16.7%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	18 100%
Year of HIV/AIDS/GRID Diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	1988 (4.8)
Palliative Performance Scale v2.0 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	92.8 (11.3)
Civil status (Count of Participants)
Single	8 44.4%
Married/Partnered	8 44.4%
Divorced/Separated	2 11.1%
Education (Count of Participants)
Less than college	5 27.8%
College or more	13 72.2%
Annual income (Count of Participants)
<$50,000	10 55.6%
≥$50,000	8 44.4%
Patients meeting current SCID-5/SCID-5-PD diagnosis (participants) [Number]
Generalized anxiety disorder	7 38.9%
Major depressive disorder	5 27.8%
Panic disorder	3 16.7%
Borderline personality disorder	3 16.7%
No SCID-5/SCID-5-PD diagnosis (of those assessed)	9 50%
PTSD Checklist-5 (PCL-5) >33/80 (Count of Participants)
Count of Participants [Participants]	3 16.7%
Lifetime: People close to you who have died (people) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [people]	17.5
Lifetime: Times used a classic psychedelic (instances) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [instances]	5
Years since last used a classic psychedelic (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	20

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Count of Participants [Participants]	18 100%

2. Primary Outcome

Title	Subject Recruitment and Retention
Description	Two therapy groups of at least 4 subjects each will complete the study
Time Frame	Duration of study, about 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Enrolled	18 100%
Completed Safety Assessment at End-of-treatment	18 100%
Completed Safety Assessment at 3-month follow-up	18 100%

3. Secondary Outcome

Title	Change From Baseline in Demoralization Scale-II at End-of-treatment
Description	Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.
Time Frame	Baseline and end-of-treatment (7 weeks duration)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-6.67 (6.5)

4. Secondary Outcome

Title	Change From Baseline in Demoralization Scale-II at 3-month Follow-up
Description	Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-5.78 (6.01)

5. Secondary Outcome

Title	Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
Description	Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Time Frame	Baseline and end-of-treatment (7 weeks duration)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-6.22 (6.74)

6. Secondary Outcome

Title	Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
Description	Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-7.06 (7.61)

7. Secondary Outcome

Title	Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
Description	Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Time Frame	Baseline and end-of-treatment (7 weeks duration)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-8.94 (14.73)

8. Secondary Outcome

Title	Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
Description	Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-8.89 (12.02)

9. Secondary Outcome

Title	Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
Description	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.

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Positive Bonding (Overall)	2.61 (4.77)
Positive Working (Overall)	1.87 (7.31)
Negative Relationship (Overall)	-0.69 (2.70)

10. Other Pre-specified Outcome

Title	Change From Baseline in PTSD Checklist 5 at End-of-treatment
Description	PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame	Baseline and end-of-treatment (7 weeks duration)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-9 (11.47)

11. Other Pre-specified Outcome

Title	Change From Baseline in PTSD Checklist 5 at 3-month Follow-up
Description	PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-7.11 (13.81)

12. Other Pre-specified Outcome

Title	Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-5.56 (9.04)

13. Other Pre-specified Outcome

Title	Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up
Description	State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	1.06 (13.23)

14. Other Pre-specified Outcome

Title	Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-6.06 (5.5)

15. Other Pre-specified Outcome

Title	Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up
Description	Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-3.39 (10.55)

16. Other Pre-specified Outcome

Title	Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-5.83 (5.23)

17. Other Pre-specified Outcome

Title	Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up
Description	HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat (data capture error for 6 participants)

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	-4.25 (4.47)

18. Other Pre-specified Outcome

Title	Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-0.78 (8.86)

19. Other Pre-specified Outcome

Title	Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up
Description	Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-3.33 (7.66)

20. Other Pre-specified Outcome

Title	Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-2.72 (6.85)

21. Other Pre-specified Outcome

Title	Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up
Description	Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.
Time Frame	Baseline and 3-month follow-up

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	-0.06 (6.3)

22. Other Pre-specified Outcome

Title	Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	2.0 (1.91)

23. Other Pre-specified Outcome

Title	Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	0.94 (2.44)

24. Other Pre-specified Outcome

Title	Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment
Description	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)

Outcome Measure Data

Analysis Population Description

intent-to-treat (one participant did not use antiretrovirals)

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	17
Mean (Standard Deviation) [units on a scale]	-0.71 (4.0)

25. Other Pre-specified Outcome

Title	Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

intent-to-treat (one participant did not use antiretrovirals)

Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
Measure Participants	17
Mean (Standard Deviation) [units on a scale]	-0.94 (2.38)

Adverse Events

Time Frame	From Baseline to 3-month follow-up (5-months post-Baseline)
Arm/Group Title	Group Therapy Plus Psilocybin
Arm/Group Description	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
All Cause Mortality
	Group Therapy Plus Psilocybin
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	Group Therapy Plus Psilocybin
	Affected / at Risk (%)	# Events
Total	3/18 (16.7%)
Gastrointestinal disorders
Cholecystitis	1/18 (5.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma	1/18 (5.6%)	1
Psychiatric disorders
Stimulant-induced psychosis	1/18 (5.6%)	1
Suicide attempt	1/18 (5.6%)	1
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/18 (5.6%)	1
Other (Not Including Serious) Adverse Events
	Group Therapy Plus Psilocybin
	Affected / at Risk (%)	# Events
Total	18/18 (100%)
Cardiac disorders
Tachycardia	2/18 (11.1%)
Gastrointestinal disorders
Nausea	6/18 (33.3%)
Nausea (post-medication visit)	1/18 (5.6%)
General disorders
Fatigue (post-medication visit)	2/18 (11.1%)
Nervous system disorders
Headache	5/18 (27.8%)
Motor agitation / Restlessness	4/18 (22.2%)
Unsteady gait / Ataxia	4/18 (22.2%)
Visual changes (complaint)	1/18 (5.6%)
Headache (post-medication visit)	8/18 (44.4%)
Psychiatric disorders
Anxiety / Anxiety Exacerbation	8/18 (44.4%)
Paranoia / Ideas of Reference	4/18 (22.2%)
Thought disorder	1/18 (5.6%)
Insomnia (post-medication visit)	2/18 (11.1%)
Anxiety exacerbation (post-medication visit)	1/18 (5.6%)
Post-traumatic stress flashback (post-medication visit)	1/18 (5.6%)
Renal and urinary disorders
Urinary incontinence	1/18 (5.6%)
Vascular disorders
Hypertension (severe, asymptomatic)	4/18 (22.2%)	4
Hypertension (moderate)	8/18 (44.4%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.