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Completed

NCT Number: NCT02950467

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

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).

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Key information

Conditions

Distress Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Genital Diseases Grief HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psilocybin

Drug

One individual oral psilocybin treatment session

Other names: 4-phosphoryloxy-N,N-dimethyltryptamine, Indocybin

Modified brief Supportive Expressive Group Therapy

Behavioral

Ten sessions of twice-weekly manualized group therapy

Primary outcomes

  1. 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

    Time frame: 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.

  2. Subject Recruitment and Retention

    Time frame: Duration of study, about 24 months

    Two therapy groups of at least 4 subjects each will complete the study

Secondary outcomes

  1. Change From Baseline in Demoralization Scale-II at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

    Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores means a worse outcome.

  2. Change From Baseline in Demoralization Scale-II at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

    Demoralization self-report measure. Minimum = 0. Maximum = 32. Higher scores mean a worse outcome.

  3. Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

    Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.

  4. Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

    Complicated Grief self-report measure. Minimum = 0, Maximum = 76. Higher scores mean worse outcome.

  5. Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

    Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.

  6. Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

    Depression self-report measure. Minimum = 0. Maximum = 60. Higher scores mean a worse outcome.

  7. Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug

    Time frame: 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

  1. Change From Baseline in PTSD Checklist 5 at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

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

  2. Change From Baseline in PTSD Checklist 5 at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

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

  3. Change From Baseline in State-Trait Anxiety Inventory (State) at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

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

  4. Change From Baseline in State-Trait Anxiety Inventory (State) at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

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

  5. Change From Baseline in State-Trait Anxiety Inventory (Trait) at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

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

  6. Change From Baseline in State-Trait Anxiety Inventory (Trait) at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

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

  7. Change From Baseline in HIV and Abuse Related Shame Inventory at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

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

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

    Time frame: Baseline and 3-month follow-up

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

  9. Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

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

  10. Change From Baseline in Experiences in Closer Relationships-M16 (Anxiety) at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

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

  11. Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at End-of-treatment

    Time frame: Baseline and end-of-treatment (7 weeks duration)

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

  12. Change From Baseline in Experiences in Closer Relationships-M16 (Avoidance) at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

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

  13. Change From Baseline in McGill Quality of Life Questionnaired-Revised (Overall) at End-of-treatment

    Time frame: 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.

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

    Time frame: 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.

  15. Change From Baseline in Antiretroviral Medication Adherence Scale at End-of-treatment

    Time frame: 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.

  16. Change From Baseline in Antiretroviral Medication Adherence Scale at 3-month Follow-up

    Time frame: Baseline and 3-month follow-up

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

Sponsors and collaborators

Lead sponsor

Joshua Woolley

Other

Collaborators

  • Heffter Research Institute
  • RiverStyx Foundation
  • Stupski Foundation
  • Usona Institute

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2016
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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