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Completed

NCT Number: NCT03607214

Longterm Effects of Expectations on Mood

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

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Key information

Conditions

Healthy Participants

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps-Universität Marburg

Marburg, Deutschland, 35037, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers
  • fluent in German language

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Other

Placebo nasal spray

Film Sequence

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Coping with stress and daily hassles, general mood and concentration.

    Time frame: On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 minutes

    The following Items are developed by the authors and will also be rated on a visual analogue scale (VAS) from 0 to 10.

    "How do you feel at the moment"? "How did you feel yesterday?" "How stress-resistent did you feel yesterday?" "How stress-resistant do you feel at the moment?"

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Longterm Effects of Expectations on Mood: An Experimental Investigation

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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