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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950467
• Other study ID #: 15-17825
• Status: Completed
• Phase: Phase 1
• Start date: January 5, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Distress
• Grief

Intervention

Drug:
• Psilocybin
One individual oral psilocybin treatment session

Behavioral:
• Modified brief Supportive Expressive Group Therapy
Ten sessions of twice-weekly manualized group therapy

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
Joshua Woolley	Heffter Research Institute, River Styx Foundation, Stupski Foundation, Usona Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in PTSD Checklist 5 at End-of-treatment	PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in PTSD Checklist 5 at 3-month Follow-up	PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.	Baseline and 3-month follow-up
Other	Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment	State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up	State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.	Baseline and 3-month follow-up
Other	Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment	Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up	Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.	Baseline and 3-month follow-up
Other	Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment	HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up	HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.	Baseline and 3-month follow-up
Other	Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment	Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up	Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.	Baseline and 3-month follow-up
Other	Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment	Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up	Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.	Baseline and 3-month follow-up
Other	Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment	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.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up	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.	Baseline and 3-month follow-up
Other	Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment	Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.	Baseline and end-of-treatment (7 weeks duration)
Other	Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up	Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.	Baseline and 3-month follow-up
Primary	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
Primary	Subject Recruitment and Retention	Two therapy groups of at least 4 subjects each will complete the study	Duration of study, about 24 months
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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.