Longterm Effects of Expectations on Mood

Philipps University Marburg90 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

PlaceboOTHER

Placebo nasal spray Film Sequence

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Philipps-Universität Marburg

Marburg, Deutschland, Germany

Outcomes

Primary Outcomes

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).

Time frame: 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 Outcomes

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?"

Time frame: On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 minutes

Data from ClinicalTrials.gov

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