Longterm Effects of Expectations on Mood

Study Overview
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Brief Summary
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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
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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.

Official Title
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Longterm Effects of Expectations on Mood: An Experimental Investigation

Conditions
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Healthy Participants

Intervention / Treatment
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* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |