Influence of Expectations on Rumination: An Experimental Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
研究概览
简要总结
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.
详细描述
Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
- •fluent in German language
排除标准
- •mental disorders
- •allergic to capsaicin
- •allergic to sesame oil
- •intake of psychopharmacological drugs in the last four weeks
- •intake of illegal drugs in the last two weeks
- •consumption of alcohol in the last twelve hours
- •students in medicine, pharmacy, or psychology
- •completed studies in medicine, pharmacy or psychology
- •current pregnancy or lactation
- •cardio vascular disease
- •kidney disease
- •liver disease
研究组 & 干预措施
Positive Expectations Group
Participants receive a nasal spray that is in fact a placebo. However, they are told that it protects from rumination. They take the nasal spray once in the laboratory.
干预措施: Active Placebo labelled as antidepessant (Other)
No-treatment control group
Participants do not receive the nasal spray.
结局指标
主要结局
Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
时间窗: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
German questionnaire of 10 Items, e.g.: "I get lost in ruminative thoughts.", "I am present in this situation.", "My thoughts are focused on the past.".All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).
Change in Positive and Negative Affect Schedule (PANAS-X)
时间窗: At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.
Items of PANAS-X: Sadness Score ("sad", "blue", "downhearted", "alone", "lonely") and Items "Surprised", "concentrating", "happy". All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).
次要结局
未报告次要终点