Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Group therapy plus psilocybin
Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.
干预措施: Psilocybin (Drug)
Group therapy plus psilocybin
Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting.
干预措施: Modified brief Supportive Expressive Group Therapy (Behavioral)
结局指标
主要结局
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
时间窗: 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
时间窗: Duration of study, about 24 months
Two therapy groups of at least 4 subjects each will complete the study
次要结局
- Change From Baseline in Demoralization Scale-II at End-of-treatment(Baseline and end-of-treatment (7 weeks duration))
- Change From Baseline in Demoralization Scale-II at 3-month Follow-up(Baseline and 3-month follow-up)
- Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment(Baseline and end-of-treatment (7 weeks duration))
- Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up(Baseline and 3-month follow-up)
- Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment(Baseline and end-of-treatment (7 weeks duration))
- Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up(Baseline and 3-month follow-up)
- 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.)
研究者
Joshua Woolley
Assistant Professor
University of California, San Francisco