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

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).

Study Overview

• Status: Completed
• Conditions: Depression; Distress; Grief
• Intervention / Treatment: Drug: Psilocybin; Behavioral: Modified brief Supportive Expressive Group Therapy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Indocybin; 4-phosphoryloxy-N,N-dimethyltryptamine; Behavioral: Modified brief Supportive Expressive Group Therapy; Ten sessions of twice-weekly manualized group therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enrollment to 3-month follow up, about 5 months
Subject Recruitment and Retention	Two therapy groups of at least 4 subjects each will complete the study	Duration of study, about 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up
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.	Baseline and end-of-treatment (7 weeks duration)
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.	Baseline and 3-month follow-up

Collaborators and Investigators

• Sponsor: Joshua Woolley
• Collaborators: Heffter Research Institute; Usona Institute; River Styx Foundation; 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

Publications and helpful links

General Publications

• Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: HIV/AIDS; Group therapy; Psilocybin; Demoralization
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Serotonin Antagonists; Hallucinogens; Psilocybin; N,N-Dimethyltryptamine
• Other Study ID Numbers: 15-17825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No