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

• ClinicalTrials.gov Identifier: NCT02950467
• Recruitment Status: Completed
• First Posted: November 1, 2016
• Results First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Sponsor: Joshua Woolley
• Collaborators: Heffter Research Institute; River Styx Foundation; Usona Institute; Stupski Foundation
• Information provided by (Responsible Party): Joshua Woolley, University of California, San Francisco

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 (Clinical Trial)
• 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: January 5, 2018
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

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

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.

Contacts and Locations

Locations

United States, California

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)

Documents provided by Joshua Woolley, University of California, San Francisco:

Study Protocol and Statistical Analysis Plan: Final protocol  [PDF] February 20, 2019

Informed Consent Form: Final ICF  [PDF] February 20, 2019

Informed Consent Form: ICF for Cohorts 2 and 3  [PDF] April 17, 2018

Study Protocol and Statistical Analysis Plan: Pre-modifications related to enrollment exceptions  [PDF] April 17, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Individual Participant Data (IPD) Sharing Statement:

• 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, University of California, San Francisco:

HIV/AIDS; Demoralization; Psilocybin; Group therapy

Additional relevant MeSH terms:

Psilocybin; Depression; Behavioral Symptoms; N,N-Dimethyltryptamine; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Receptor Agonists