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

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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

Tracking Information
First Submitted Date  ICMJE October 26, 2016
First Posted Date  ICMJE November 1, 2016
Results First Submitted Date  ICMJE September 21, 2020
Results First Posted Date  ICMJE January 7, 2021
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE January 5, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2020)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
Incidence of treatment-related adverse events as assessed by DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [ Time Frame: Enrollment to 3-month follow up, about 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • 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
  • Change from baseline in Demoralization Scale-II at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  • Change From Baseline in Demoralization Scale-II at 3-month Follow-up [ Time Frame: Baseline and 3-month follow-up ]
  • Change from baseline in Inventory of Complicated Grief at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  • Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up [ Time Frame: Baseline and 3-month follow-up ]
  • Change from baseline in Center for Epidemiologic Studies Depression Scale-Revised at endpoint [ Time Frame: Baseline and endpoint (10 weeks duration) ]
  • Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up [ Time Frame: Baseline and 3-month follow-up ]
  • Change in slope of Group Questionnaire pre-psilocybin and post-psilocybin [ Time Frame: Group therapy sessions 1, 3, 6 and 8 ]
    Group cohesion measure
Current Other Pre-specified Outcome Measures
 (submitted: December 13, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Official Title  ICMJE Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Distress
  • Depression
  • Grief
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Psilocybin
  • Behavioral: Modified brief Supportive Expressive Group Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
36
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02950467
Other Study ID Numbers  ICMJE 15-17825
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joshua Woolley, University of California, San Francisco
Study Sponsor  ICMJE Joshua Woolley
Collaborators  ICMJE
  • Heffter Research Institute
  • River Styx Foundation
  • Usona Institute
  • Stupski Foundation
Investigators  ICMJE
Principal Investigator: Joshua Woolley, MD,PhD University of California, San Francisco
Study Director: Brian Anderson, MD,MSc University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP