Official Title
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Phase
Phase 1Lead Sponsor
University of California, San FranciscoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Distress Depression GriefIntervention/Treatment
psilocybin ...Study Participants
30The 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.
One individual oral psilocybin treatment session
Ten sessions of twice-weekly manualized group therapy
Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.
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.
| Event Type | Organ System | Event Term | Group Therapy Plus Psilocybin |
|---|
Two therapy groups of at least 4 subjects each will complete the study
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.
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.
Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means 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.
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.
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.
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.
