Longterm Effects of Expectations on Mood

NCT03607214 | Completed

• 1 other identifier: 2018-15k
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Coping with stress and daily hassles, general mood and concentration.

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

Study Arms (2)

Positive Expectations Group

EXPERIMENTAL

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

No-treatment control group

NO INTERVENTION

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

Interventions

Placebo OTHER

Placebo nasal spray Film Sequence

Positive Expectations Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers
• fluent in German language

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps-Universität Marburg

Marburg, Deutschland, 35037, Germany

Location

Study Officials

• Winfried Rief, Professor

  Philipps-Univeristy of Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2018
• First Posted: July 31, 2018
• Study Start: November 1, 2018
• Primary Completion: April 15, 2019
• Study Completion: May 15, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)