NCT05570708Enrolling By Invitation不适用
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
Felix Mueller1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年10月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- TASC-2 scale
研究概览
简要总结
The study investigates two groups of participants of the SÄPT therapist's training starting in October 2022. The overall objective is to investigate the risks and benefits of personal experience (PE) with substance-induced altered states of consciousness for physicians or psychotherapists in the context of a training course for substance-assisted therapy. Specifically, the study aims to assess changes in therapeutic attitude and other factors important in interactions between patients and therapists (such as empathy and cognitive flexibility).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in the SÄPT therapist training (medical doctors and psychologists)
- •Age 27 years or older
- •Sufficient understanding of the German language
- •Understanding of procedures and risks associated with the study
- •Willing to adhere to the protocol and signing of the consent form
- •Willing not to operate heavy machinery (including driving cars) within 24 hours after substance administration
- •Woman of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository at least one month before and after each study substance intervention, and are willing to take a urine pregnancy test at the medical screening and before every study substance intervention.
- •Men are required to use contraceptive methods in the month after each study substance intervention and are required to inform their partner(s) about their study participation.
排除标准
- •Previous significant adverse response to a hallucinogenic drug
- •Significant medical condition rendering volunteers unsuitable for participation (such as impaired kidney or liver function, or heart disease incl. uncontrolled hypertension or hypotension)
- •Strong underweight (<45kg)
- •Current major psychiatric disorder (including personality disorder, including suicidality) and / or previous psychotic or bipolar disorder.
- •Psychotic disorder or bipolar disorder in first-degree relatives
- •Use of medication that may interfere with the effects of the study medication. Patients must be willing to discontinue medications in cases where drug-related interactions are possible (the washout phase will be at least 5 times the particular drug's half-life [typically 3-7 days] prior to the respective study session). Discontinuation of medication must be judged to be acceptable by the responsible investigator.
- •Women are excluded from substance intervention during pregnancy or breastfeeding.
- •nParticipation in another clinical trial (currently or within the last 30 days)
研究组 & 干预措施
Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD
Experimental
干预措施: MDMA, LSD, psilocybin (Drug)
结局指标
主要结局
TASC-2 scale
时间窗: Three weeks after last PE
The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)
次要结局
- PIQ(Directly after each PE)
- 5D-ASC(Directly after each PE)
- APEQ(Directly after each PE)
- CSOWD(Directly after each PE)
- SPF/IRI(Three weeks after each PE and six months after last PE)
- CEQ(Directly after each PE)
- BFW/E(Three weeks after each PE and six months after last PE)
- SOCS-S(Three weeks after each PE and six months after last PE)
- SPCS-O(Three weeks after each PE and six months after last PE)
- EBI(Directly after each PE)
- PEQ(Three weeks after each PE and six months after last PE)
- semi-structured interview(Five months after last PE)
- TASC-2 scale(Three weeks after each PE and six months after last PE)
研究者
Felix Mueller
Sponsor-Investigator PD Dr. med. Felix Müller MD
University Hospital, Basel, Switzerland
研究点 (1)
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