Clinical trial NCT02950467: Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Official title: Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Distress
Depression
Grief
Keywords: HIV/AIDS
Demoralization
Psilocybin
Group therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Heffter Research Institute
name: RiverStyx Foundation
name: Usona Institute
name: Stupski Foundation
First posted: 2016-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:
measure: 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
timeFrame: Enrollment to 3-month follow up, about 5 months
measure: Subject Recruitment and Retention
timeFrame: Duration of study, about 24 months
Secondary outcomes:
measure: Change From Baseline in Demoralization Scale-II at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in Demoralization Scale-II at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug
timeFrame: Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication.
Other outcomes:
measure: Change From Baseline in PTSD Checklist 5 at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in PTSD Checklist 5 at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment
timeFrame: Baseline and end-of-treatment (7 weeks duration)
measure: Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up
timeFrame: Baseline and 3-month follow-up
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joshua Woolley, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Brian Anderson, MD,MSc
role: STUDY_DIRECTOR
References:
citation: 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.