Longterm Effects of Expectations on Mood

NCT ID: NCT03607214

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-05-15

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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Placebo nasal spray

Film Sequence

No-treatment control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Placebo

Placebo nasal spray

Film Sequence

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winfried Rief, Professor

Role: PRINCIPAL_INVESTIGATOR

Philipps-Univeristy of Marburg

Locations

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Philipps-Universität Marburg

Marburg, Deutschland, Germany

Site Status

Countries

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Germany

Other Identifiers

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2018-15k

Identifier Type: -

Identifier Source: org_study_id

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