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临床试验/NCT03607214
NCT03607214已完成不适用

Longterm Effects of Expectations on Mood: An Experimental Investigation

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

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 Positive and Negative Affect Schedule (PANAS-X)

研究概览

简要总结

The study tries to identify whether positive expectations, induced with a placebo nasal-spray, have short- and longterm effects on participant's mood.

详细描述

Healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. They will randomly be assigned to the experimental group (taking the antidepressant which is in fact an active placebo) or the control group (not taking a placebo). Then participants watch a well established film sequence to induce sadness. Sadness is assessed before and after receiving the nasal spray and watching the film sequence. In the seven consecutive days the participant's mood is assessed each day, only the experimental group is taking the placebo each day. Afterwards participants will watch another sad film sequence and sadness will be assessed before and afterwards.

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 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
  • •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

研究组 & 干预措施

Positive Expectations Group

Experimental

Participants receive a nasal spray that is in fact a placebo. However, they are told that it protects from experiencing negative emotions and generally improves their mood. They take the nasal spay in the laboratory and on seven consecutive days. Participants watch two film sequences that are supposed to induce sadness.

干预措施: Placebo (Other)

No-treatment control group

No Intervention

Participants do not receive the nasal spray. Participants watch two film sequences that are supposed to induce sadness.

结局指标

主要结局

Change in Positive and Negative Affect Schedule (PANAS-X)

时间窗: Directly before and after watching the film sequence and on the following seven days, each assessment is taking four minutes, in total 36 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

  • Coping with stress and daily hassles, general mood and concentration.(On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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