A Retrospective Study Determine the Impact of Psychedelic Therapy for Dimensional Measures of Wellness
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- patient's global impression of change
研究概览
简要总结
The overall aim of this study is to assess the efficacy psychedelics for improving measures of wellness using a retrospective, single period, cohort study
详细描述
Previous research has largely focused on treating specific diagnostics groups such as depression, chronic pain, anxiety disorders with various approaches. With the significant overlap in symptomology with respect to diagnostic criteria and the presence of comorbidity, the results are challenging to extrapolate to real world applications. Therefore many authors have argued relying less on specific diagnoses, and instead focus on wellness, where symptom clusters or so called dimensions are explored independently.
The WHO constitution states: "Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." An important implication of this definition is that health is more than just the absence of disorders or disabilities. Health is a state of well-being in which an individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and is able to contribute to his or her community.
Research Objective: In the current research investigators seek to measure the self-reported treatment effects of psychedelics (Psilocybin, 3,4-Methylenedioxymethamphetamine, N,N-Dimethyltryptamine, Lysergic Acid Diethylamide and Ketamine) for non recreational purposes (i.e., to self-medicate to ameliorate symptoms of suffering). Investigators will use a composite score of patient global perception, along with pain, function and mood scores as the measure of wellness, an approach to measurement which has not been done to date. Investigators follow previous work in this area, using a patient retrospective self-report study design, allowing for a safe way to develop further evidence in this area of care.
Participants and Procedure: 50 non active military participants not under the care of Dr. Gupta will be recruited through word of mouth and advertising to self-identify as having used psychedelic medicine for non recreational purposes (Appendix B recruitment letter). In addition to demographic information, they will be asked to complete the PGIC and anxiety, mood, pain and disability subscales, PEG, HADS and DI, provide information on their past medical history, nature/indications for use, and adverse events. This data will be collected once per participant and they will be able to speak with a research associate if further clarification if necessary at anytime.
Risks and Risk Mitigation: Participation in this study is voluntary and volunteers can withdraw consent at any time or skip any question they would prefer not to answer without having any effect on access to future medical care. Due to the nature of this study there are no additional associated risks. Patients can ask to be contacted by the research team should they wish to discuss any concerns, but will be apprised that this will breach their anonymity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 - 99
- •Self-report of past psychedelic medicine use for therapeutic purposes in the last 3 years
- •While a consent letter will be provided, patients will only be asked to agree to the terms without providing their names (i.e., unsigned consent procedures) given the potential legal ramifications of identification
- •Civilian or military veterans.
排除标准
- •Past psychedelic medicine use for non- therapeutic purposes
- •Only the most recent experience will be commented on
- •Active Military Members
- •Given the retrospective nature of the trial no other exclusion criteria outside not meeting the inclusion criteria are necessary.
- •In general patient participation will be anonymous given that access to medication may not have been considered legal. However in cases where there are concerns about a serious health issues and the patient can be identified, they will be to ensure appropriate follow up can be arranged.
研究组 & 干预措施
psychedelics
50 non active military participants not under the care of Dr. Gupta will be recruited through word of mouth and advertising to self-identify as having used psychedelic medicine for non recreational purposes (Appendix B recruitment letter). In addition to demographic information, they will be asked to complete the PGIC and anxiety, mood, pain and disability subscales, PEG, HADS and DI, provide information on their past medical history, nature/indications for use, and adverse events. This data will be collected once per participant and they will be able to speak with a research associate if further clarification if necessary at anytime.
干预措施: Psychedelic (Drug)
结局指标
主要结局
patient's global impression of change
时间窗: retrospective used in last 3 years
patient's global impression of change (PGIC) has been used to estimate clinical change with a score of at least (moderate/much better), will be considered the minimally important clinically important difference. Scores 1-7 with higher scores associated with better outcome.
次要结局
- Hospital Anxiety and Depression Scale(baseline (current))
- Pain, Enjoyment and General Activity Scale (PEG)(baseline (current))
- The Disability Index (DI)(baseline (current))
研究者
Gaurav Gupta
Principal Investigator
Canadian Forces Health Services Centre Ottawa
