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

Study Overview
=================
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.

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

Conditions
-----------------
Distress, Depression, Grief

Intervention / Treatment
-----------------
* Drug: Psilocybin
* Behavioral: Modified brief Supportive Expressive Group Therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group therapy plus psilocybin<br>Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. | Drug: Psilocybin<br>* One individual oral psilocybin treatment session<br>* Other names: Indocybin;Behavioral: Modified brief Supportive Expressive Group Therapy<br>* Ten sessions of twice-weekly manualized group therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Duration of study, about 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Mean scores averaged over 2 weeks pre-medication compared to 3 weeks post-medication. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV/AIDS, Demoralization, Psilocybin, Group therapy