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

Primary Outcomes

• 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 Outcomes

• 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.

Other Outcomes

• Change From Baseline in PTSD Checklist 5 at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

• Change From Baseline in PTSD Checklist 5 at 3-month Follow-up Baseline and 3-month follow-up

  PTSD self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

• Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

• Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up Baseline and 3-month follow-up

  State anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

• Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

• Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up Baseline and 3-month follow-up

  Trait anxiety self-report measure. Minimum = 0. Maximum = 80. Higher scores mean a worse outcome.

• Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.

• Change From Baseline in HIV and Abuse Related Shame Inventory at 3-month Follow-up Baseline and 3-month follow-up

  HIV-related shame self-report measure. Minimum = 0. Maximum = 52. Higher scores mean a worse outcome.

• Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

• Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up Baseline and 3-month follow-up

  Self-report measure of attachment anxiety. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

• Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

• Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up Baseline and 3-month follow-up

  Self-report measure of attachment avoidance. Minimum = 8. Maximum = 56. Higher scores mean worse outcomes.

• Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  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.

• Change From Baseline in McGill Quality of Life Questionnaire-Revised (Overall) at 3-month Follow-up Baseline and 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.

• Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment Baseline and end-of-treatment (7 weeks duration)

  Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.

• Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up Baseline and 3-month follow-up

  Self-report last-month antiviral medication adherence. Minimum = 0%. Maximum = 100%. Higher scores mean a better outcome.