Longterm Effects of Expectations on Mood

Healthy Participants Clinical Trial

Official title:

Longterm Effects of Expectations on Mood: An Experimental Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607214
• Other study ID #: 2018-15k
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: August 2019
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Other:
• Placebo
Placebo nasal spray Film Sequence

Locations

Country	Name	City	State
Germany	Philipps-Universität Marburg	Marburg	Deutschland

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Positive and Negative Affect Schedule (PANAS-X)	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).	Directly before and after watching the film sequence and on the following seven days, each assessment is taking four minutes, in total 36 minutes.
Secondary	Coping with stress and daily hassles, general mood and concentration.	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?"	On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 minutes