Longterm Effects of Expectations on Mood

Longterm Effects of Expectations on Mood: An Experimental Investigation

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

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Deutschland
    • Marburg, Deutschland, Germany, 35037
      • Philipps-Universität Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Professor, Philipps-Univeristy of Marburg

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: June 16, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-15k

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No