Official Title

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

    Phase 1
  • Study Type

    Interventional
  • Intervention/Treatment

    psilocybin ...
  • Study Participants

    30
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).
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 Started
Jan 05
2018
Primary Completion
Dec 31
2019
Study Completion
Dec 31
2019
Results Posted
Jan 07
2021
Last Update
Jan 07
2021

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

Group therapy plus psilocybin Experimental

Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.

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.

Summary

Group Therapy Plus Psilocybin

All Events

Event Type Organ System Event Term 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

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.

Group Therapy Plus Psilocybin

Subject Recruitment and Retention

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

Group Therapy Plus Psilocybin

Completed Safety Assessment at 3-month follow-up

Completed Safety Assessment at End-of-treatment

Enrolled

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.

Group Therapy Plus Psilocybin

-6.67
units on a scale (Mean)
Standard Deviation: 6.5

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.

Group Therapy Plus Psilocybin

-5.78
units on a scale (Mean)
Standard Deviation: 6.01

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.

Group Therapy Plus Psilocybin

-6.22
units on a scale (Mean)
Standard Deviation: 6.74

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.

Group Therapy Plus Psilocybin

-7.06
units on a scale (Mean)
Standard Deviation: 7.61

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.

Group Therapy Plus Psilocybin

-8.94
units on a scale (Mean)
Standard Deviation: 14.73

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.

Group Therapy Plus Psilocybin

-8.89
units on a scale (Mean)
Standard Deviation: 12.02

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.

Group Therapy Plus Psilocybin

Negative Relationship (Overall)

-0.69
score on a scale (Mean)
Standard Deviation: 2.70

Positive Bonding (Overall)

2.61
score on a scale (Mean)
Standard Deviation: 4.77

Positive Working (Overall)

1.87
score on a scale (Mean)
Standard Deviation: 7.31

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.

Group Therapy Plus Psilocybin

-9.0
units on a scale (Mean)
Standard Deviation: 11.47

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.

Group Therapy Plus Psilocybin

-7.11
units on a scale (Mean)
Standard Deviation: 13.81

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.

Group Therapy Plus Psilocybin

-5.56
units on a scale (Mean)
Standard Deviation: 9.04

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.

Group Therapy Plus Psilocybin

1.06
units on a scale (Mean)
Standard Deviation: 13.23

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.

Group Therapy Plus Psilocybin

-6.06
units on a scale (Mean)
Standard Deviation: 5.5

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.

Group Therapy Plus Psilocybin

-3.39
units on a scale (Mean)
Standard Deviation: 10.55

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.

Group Therapy Plus Psilocybin

-5.83
units on a scale (Mean)
Standard Deviation: 5.23

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.

Group Therapy Plus Psilocybin

-4.25
units on a scale (Mean)
Standard Deviation: 4.47

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.

Group Therapy Plus Psilocybin

-0.78
units on a scale (Mean)
Standard Deviation: 8.86

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.

Group Therapy Plus Psilocybin

-3.33
units on a scale (Mean)
Standard Deviation: 7.66

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.

Group Therapy Plus Psilocybin

-2.72
units on a scale (Mean)
Standard Deviation: 6.85

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.

Group Therapy Plus Psilocybin

-0.06
units on a scale (Mean)
Standard Deviation: 6.3

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.

Group Therapy Plus Psilocybin

2.0
units on a scale (Mean)
Standard Deviation: 1.91

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.

Group Therapy Plus Psilocybin

0.94
units on a scale (Mean)
Standard Deviation: 2.44

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.

Group Therapy Plus Psilocybin

-0.71
units on a scale (Mean)
Standard Deviation: 4.0

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.

Group Therapy Plus Psilocybin

-0.94
units on a scale (Mean)
Standard Deviation: 2.38

Age, Continuous

59.2
years (Mean)
Standard Deviation: 4.4

Lifetime: People close to you who have died

17.5
people (Median)
Inter-Quartile Range: 7.25 to 30.0

Lifetime: Times used a classic psychedelic

5
instances (Median)
Inter-Quartile Range: 3.0 to 23.0

Palliative Performance Scale v2.0

92.8
units on a scale (Mean)
Standard Deviation: 11.3

PTSD Checklist-5 (PCL-5) >33/80

3
Participants

Year of HIV/AIDS/GRID Diagnosis

1988
years (Mean)
Standard Deviation: 4.8

Years since last used a classic psychedelic

20
years (Median)
Inter-Quartile Range: 1.0 to 32.0

Annual income

Civil status

Education

Ethnicity (NIH/OMB)

Patients meeting current SCID-5/SCID-5-PD diagnosis

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Open-label Treatment

Group Therapy Plus Psilocybin

3-month Follow-up

Group Therapy Plus Psilocybin