Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborators:
Heffter Research Institute
River Styx Foundation
Usona Institute
Stupski Foundation
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950467


Locations
Layout table for location information
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
Layout table for investigator information
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:
Informed Consent Form: Final ICF  [PDF] February 20, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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    Key Record Dates
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

Layout table for additional information
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:
Layout table for 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