Psilocybin Therapy for Advanced Cancer-related Psychiatric Distress

裸盖菇素治疗晚期癌症相关精神困扰

• 批准号: 10534022
• 负责人: STACY M FISCHER
• 金额: $ 68.16万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-04 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10534022
• 关键词: Acute; Address; Adjustment Disorders; Advanced Malignant Neoplasm; Adverse effects; Affect; Antidepressive Agents; Anxiety; Anxiety Disorders; Attention; Behavior; Behavior Therapy; Cancer Patient; Cessation of life; Clinical; Clinical Research; Cognition; Cognitive; Data; Distress; Dose; Double-Blind Method; Effectiveness; Emotional; Ensure; Environment; Evidence based intervention; Feeling hopeless; Foundations; Goals; Hallucinogens; Health; Hour; Human; Integrative Therapy; Intervention; Life; Long-Term Depression; Long-Term Effects; Major Depressive Disorder; Malignant Neoplasms; Measures; Mental Depression; Mental Health; Mind; Moods; Outcome; Outcome Study; Pain; Participant; Patient Care; Patient Self-Report; Patients; Personal Satisfaction; Personality Traits; Persons; Pharmaceutical Preparations; Pharmacology; Physiological; Placebo Control; Placebos; Preparation; Prevalence; Psychotherapy; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Relapse; Research; SEER Program; Safety; Sampling; Science; Site; Spirituality; Survival Rate; Testing; Therapeutic; Therapeutic Uses; Time; Treatment Efficacy; Treatment Protocols; Tryptamines; Work; base; cancer care; cancer diagnosis; cancer survival; cancer therapy; clinical care; clinically significant; common treatment; completed suicide; death anxiety; design; disability; dysphoria; effective therapy; emotional distress; experience; flexibility; follow-up; improved; innovation; life-limiting cancer; medication compliance; medication nonadherence; mental state; mortality; novel therapeutic intervention; open label; peace; placebo group; psychiatric comorbidity; psychologic; psychosocial; response; success; trait; Acute; Address; Adjustment Disorders; Advanced Malignant Neoplasm; Adverse effects; Affect; Antidepressive Agents; Anxiety; Anxiety Disorders; Attention; Behavior; Behavior Therapy; Cancer Patient; Cessation of life; Clinical; Clinical Research; Cognition; Cognitive; Data; Distress; Dose; Double-Blind Method; Effectiveness; Emotional; Ensure; Environment; Evidence based intervention; Feeling hopeless; Foundations; Goals; Hallucinogens; Health; Hour; Human; Integrative Therapy; Intervention; Life; Long-Term Depression; Long-Term Effects; Major Depressive Disorder; Malignant Neoplasms; Measures; Mental Depression; Mental Health; Mind; Moods; Outcome; Outcome Study; Pain; Participant; Patient Care; Patient Self-Report; Patients; Personal Satisfaction; Personality Traits; Persons; Pharmaceutical Preparations; Pharmacology; Physiological; Placebo Control; Placebos; Preparation; Prevalence; Psychotherapy; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Relapse; Research; SEER Program; Safety; Sampling; Science; Site; Spirituality; Survival Rate; Testing; Therapeutic; Therapeutic Uses; Time; Treatment Efficacy; Treatment Protocols; Tryptamines; Work; base; cancer care; cancer diagnosis; cancer survival; cancer therapy; clinical care; clinically significant; common treatment; completed suicide; death anxiety; design; disability; dysphoria; effective therapy; emotional distress; experience; flexibility; follow-up; improved; innovation; life-limiting cancer; medication compliance; medication nonadherence; mental state; mortality; novel therapeutic intervention; open label; peace; placebo group; psychiatric comorbidity; psychologic; psychosocial; response; success; trait

Project Summary/ Abstract An estimated 30-40% of cancer patients experience clinically significant anxiety and depression. The burden of suffering caused by psychiatric distress has profound negative impacts on quality of life (QOL), medication adherence, increased rates of completed suicide, and even decreased cancer survival rates. Approximately 25% of cancer patients with advanced or terminal cancer experience clinically significant existential distress characterized by demoralization, hopelessness, absence of purpose or meaning, loss of dignity, and hastened desire for death. Pharmacologic and psychosocial treatments are commonly used to treat depression, anxiety and existential distress in cancer patients, but their effectiveness is limited and mixed. Psilocybin is a psychedelic tryptamine with a good physiologic-psychological safety profile in human lab and clinical research, producing highly salient meaningful experiences, often described as spiritual/mystical states of mind, associated with enduring (months to years) positive changes in cognition, affect, behavior, and spirituality. Based on extensive preliminary data, psilocybin-assisted therapy has demonstrated both safety and preliminary efficacy to improve cancer-related depression and anxiety (effect size = 0.82-1.69), and existential distress while improving quality of life, Participants in preliminary trials found the experience to be both acceptable and highly meaningful and spiritual. Building on this strong foundation of preliminary work, we propose to conduct a two-site, active placebo-controlled, double-blind, parallel design, randomized controlled trial of single high dose psilocybin-assisted therapy versus active placebo (very low dose psilocybin) for 200 participants with advanced cancer and baseline psychiatric distress. All participants will receive preparatory, active dosing, and integrative therapy sessions as part of the psilocybin and active placebo groups. We propose to conduct the following aims: 1) To assess the short- and long-term effects of psilocybin on mental health (e.g. anxiety, depression, existential distress) outcomes; 2) To assess the effects of psilocybin on QOL; and 3) To evaluate the contribution of psilocybin-induced psychological change mechanisms (mystical experience, personality trait openness, cognitive flexibility) on acute and long-term mental health outcomes (depression, anxiety, existential distress). We will collect baseline measures and follow up of outcomes at 1 day, 1 week, 8 weeks, 12 weeks, and 24 weeks (6 months). The proposed study will impact clinical care for persons with advanced cancer by testing an innovative, evidence-based intervention to improve depression, anxiety, existential distress, and quality of life. The study is significant because it addresses important mental health domains of suffering in patients with life-limiting cancer. The study is innovative as the potentially first effective therapy to impact existential distress. Furthermore, this study will further the science by evaluating the psychological change mechanisms for this promising new therapeutic intervention.

项目摘要/摘要 估计有30-40％的癌症患者患有临床上显着的焦虑和抑郁。负担 由精神障碍造成的痛苦对生活质量（QOL），药物治疗产生了深远的负面影响 依从性，自杀的率提高，甚至降低了癌症的存活率。大约 25％的晚期或晚期癌症患者经历了临床上显着的生存困扰 以沮丧，绝望，缺乏目的或意义，尊严的丧失和加速为特征 渴望死亡。药理学和社会心理治疗通常用于治疗抑郁症，焦虑症 癌症患者的生存困扰，但其有效性有限和混合。 psilocybin是 迷幻色氨酸在人类实验室和临床研究中具有良好的生理心理安全性概况， 产生高度显着有意义的经历，通常被描述为精神/神秘的心理状态， 与持久（几个月至数年）的积极变化有关，对认知，情感，行为和灵性。 基于广泛的初步数据，psilocybin辅助疗法既表现出安全性，又显示 提高癌症相关抑郁和焦虑的初步疗效（效果大小= 0.82-1.69），并且存在 在改善生活质量的同时，初步试验的参与者发现这两者都是 可以接受，高度有意义和精神。我们以这一强大的初步工作为基础 提议进行两端，主动安慰剂对照，双盲，平行设计，随机控制 单剂量psilocybin辅助治疗与活性安慰剂（非常低剂量psilocybin）的试验200 患有晚期癌症和基线精神病患者的参与者。所有参与者都会收到准备， 作为psilocybin和活跃安慰剂组的一部分，主动剂量和整合治疗课程。我们 建议进行以下目的：1）评估psilocybin对心理的短期和长期影响 健康（例如焦虑，抑郁，生存困扰）的结果； 2）评估psilocybin对QOL的影响； 3）评估psilocybin诱导的心理变化机制的贡献（神秘 经验，性格开放性，认知灵活性）急性和长期心理健康成果 （抑郁，焦虑，生存困扰）。我们将收集基线措施并在1处收到结果 一天，1周，8周，12周和24周（6个月）。拟议的研究将影响临床护理 患有晚期癌症的人通过测试创新的，基于证据的干预措施以改善抑郁症， 焦虑，存在的困扰和生活质量。这项研究很重要，因为它解决了重要的心理 生命癌症患者的健康领域。这项研究具有创新性，因为 有效影响生存困扰的疗法。此外，这项研究将通过评估 这种有希望的新治疗干预的心理变化机制。