Influence of Expectations on Rumination

Study Overview
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Brief Summary
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The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.

Detailed Description
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Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the medication. Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. Think about what your feelings might mean.). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.

Official Title
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Influence of Expectations on Rumination: An Experimental Investigation

Conditions
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Depression

Intervention / Treatment
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* Other: Active Placebo labelled as antidepessant


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 in the last four weeks 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 current pregnancy or lactation cardio vascular disease kidney disease liver disease

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: Treatment
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 rumination. They take the nasal spray once in the laboratory. | Other: Active Placebo labelled as antidepessant<br>* Participants receive an active nasal spray that is in fact a placebo.<br>|
| No Intervention: No-treatment control group<br>Participants do not receive the nasal spray. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung) | German questionnaire of 10 Items, e.g.: I get lost in ruminative thoughts., I am present in this situation., My thoughts are focused on the past..All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much). | At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes. | 
| 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). | At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes. |