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).

Intervention / Treatment

  • Psilocybin (DRUG)
    One individual oral psilocybin treatment session
  • Modified brief Supportive Expressive Group Therapy (BEHAVIORAL)
    Ten sessions of twice-weekly manualized group therapy

Condition or Disease

  • Distress
  • Depression
  • Grief

Phase

  • Phase 1
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 50 Years and older   (Adult, Older Adult)
    Enrollment: 30 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jan 05, 2018 ACTUAL
    Primary Completion: Dec 31, 2019 ACTUAL
    Completion Date: Dec 31, 2019 ACTUAL
    Study First Posted: Nov 01, 2016 ESTIMATED
    Results First Posted: Jan 07, 2021 ACTUAL
    Last Updated: Dec 13, 2020

    Sponsors / Collaborators

    Lead Sponsor: Joshua Woolley
    Responsible Party: Joshua Woolley

    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.

    Participant Groups

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 50
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • 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.

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

    Secondary Outcomes
    • Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.

    • Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.

    • Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.

    • Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.

    • Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.

    • Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.

    • 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 Outcomes
    • PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

    • PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

    • State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

    • State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

    • Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

    • Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

    • HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.

    • HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.

    • Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

    • Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

    • Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

    • Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

    • 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.

    • 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.

    • Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.

    • Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.

    More Details

    NCT Number: NCT02950467
    Other IDs: 15-17825
    Study URL: https://clinicaltrials.gov/study/NCT02950467
    Last updated: Sep 29, 2023