Longterm Effects of Expectations on Mood

Not Applicable

Completed

• Conditions: Healthy Participants
• Interventions: Other: Placebo

• Registration Number: NCT03607214
• Lead Sponsor: Philipps University Marburg Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-06-16
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Study Start: 2018-11-01
• Primary Completion: 2019-04-15
• Study Completion: 2019-05-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Expectations Group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Affect Schedule (PANAS-X)	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 Outcome Measures

Name	Time	Method
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	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?"

Trial Locations

Locations (1)

Philipps-Universität Marburg; 🇩🇪 Marburg, Deutschland, Germany