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

Phase 1

Completed

• Conditions: Distress; Depression; Grief
• Interventions: Drug: Psilocybin; Behavioral: Modified brief Supportive Expressive Group Therapy

• Registration Number: NCT02950467
• Lead Sponsor: Joshua Woolley

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 Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-11-01
• Study Start: 2018-01-05
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2020-09-21
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-13
• Last Update Submitted: 2020-12-13
• Results First Posted: 2021-01-07
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group therapy plus psilocybin	Modified brief Supportive Expressive 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.
Group therapy plus psilocybin	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.

Primary Outcome Measures

Name	Time	Method
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	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	Duration of study, about 24 months	Two therapy groups of at least 4 subjects each will complete the study

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Demoralization Scale-II at End-of-treatment	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States