Taking Open Label Placebo Further: Randomized Controlled Trial of Imaginary Pills in Test Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Change in Prüfungsangstfragebogen (PAF) questionnaire
研究概览
简要总结
Employing imaginary pills could offer a new way of investigating underlying mechanisms of open label placebo (OLP) treatment by eliminating the physical treatment constituent (i.e., the pill itself). This can reveal the power of the purely psychological component of a placebo and gives insights into underlying mechanisms of placebo effects. The aim of the project is to assess possible effects of an imaginary pill in comparison to no treatment, and open label placebo treatment in subjects with test anxiety.
Interventions (seven to three weeks before the exam) will be held online using a video Chat application such as zoom (https://zoom.us/) or skype (https://www.skype.com/de/) or will take place at the division of Clinical Psychology and Psychotherapy, University of Basel (Missionsstrasse 62, 4055 Basel).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having an exam at the end of the semester, that is still at least four weeks ahead
- •Self-reported fear of the exam (i.e., not clinical)
- •Healthy by self-report statement (i.e., no known current or chronic somatic diseases or psychiatric disorders)
- •Willing to participate in study
排除标准
- •Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
- •Current medications (psychoactive medication, narcotics, intake of analgesics)
- •Any psychiatric disorders or being currently in psychological or psychiatric treatment
- •Insufficient German language skills to understand the instructions
- •Daily consumption of more than three alcoholic standard beverages (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
- •Current or regular drug consumption
- •Being a master student in Psychology
- •Allergy of one of the ingredients of the placebo pills (P-Dragees blue Lichtenstein)
- •Problems to swallow pills
结局指标
主要结局
Change in Prüfungsangstfragebogen (PAF) questionnaire
时间窗: from seven to three weeks before the exam (t0; baseline assessment), after study visit (t1) once a week for the following two weeks (t2-t3; midpoint assessments), baseline (t0 = 4 weeks to exam)) to posttreatment (t4 = 2to 0 days to exam )
The PAF questionnaire consisting of 20 items with four subscales (worry, emotionality, interference, lack of confidence) is a multi-faceted measure of test anxiety. Each subscale consists of five items with a total of 20 questions overall. Response on a 4-point Likert-scale ranging from 1 (almost never) to 4 (almost always).
次要结局
- test performance(assessed two months after the exam)
- Change in the Pittsburgh Sleep Quality Index (PSQI)(from seven to three weeks before the exam (t0; baseline assessment), after study visit (t1) once a week for the following two weeks (t2-t3; midpoint assessments), baseline (t0 = 4 weeks to exam)) to posttreatment (t4 = 2to 0 days to exam ))
- semi-structured qualitative interview with open-ended questions(30-60 min duration after personal study conclusion (1 to 5 weeks after exam))
- Change in Change-sensitive symptom list (ASS-SYM symptom list)(from seven to three weeks before the exam (t0; baseline assessment), after study visit (t1) once a week for the following two weeks (t2-t3; midpoint assessments), baseline (t0 = 4 weeks to exam)) to posttreatment (t4 = 2to 0 days to exam ))