Longterm Effects of Expectations on Mood

Sponsor

Philipps University Marburg Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03607214

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Longterm Effects of Expectations on Mood: An Experimental Investigation

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Apr 15, 2019

Actual Study Completion Date :

May 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Positive Expectations Group 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.	Other: Placebo Placebo nasal spray Film Sequence
No Intervention: No-treatment control group Participants do not receive the nasal spray. Participants watch two film sequences that are supposed to induce sadness.

Arm

Intervention/Treatment

Experimental: Positive Expectations Group

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.

Other: Placebo

Placebo nasal spray Film Sequence

No Intervention: No-treatment control group

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

Outcome Measures

Primary Outcome Measures

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

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?"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Philipps-Universität Marburg	Marburg	Deutschland	Germany	35037

Sponsors and Collaborators

Philipps University Marburg Medical Center

Investigators

Principal Investigator: Winfried Rief, Professor, Philipps-Univeristy of Marburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philipps University Marburg Medical Center

ClinicalTrials.gov Identifier:

NCT03607214

Other Study ID Numbers:

2018-15k

First Posted:

Jul 31, 2018

Last Update Posted:

Aug 16, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 16, 2019