Depression Clinical Trial
Official title:
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Verified date | December 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Joshua Woolley | Heffter Research Institute, River Styx Foundation, Stupski Foundation, Usona Institute |
United States,
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. |
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