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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
One individual oral psilocybin treatment session
Ten sessions of twice-weekly manualized group therapy
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: 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
Time frame: Duration of study, about 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.