NCT02848352

Brief Summary

The study aimed at identifying whether different expectations have an impact on experiencing emotions in the form of sadness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 6, 2017

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

June 29, 2016

Last Update Submit

April 4, 2017

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • Sadness (PANAS-X)

    Directly after watching the film sequence, no follow-up assessments

Study Arms (4)

Positive placebo group

EXPERIMENTAL

Participants receive a nasal spray that is a placebo. However, they are told that it protects from experiencing negative emotions. Participants watch a film sequence that is supposed to induce sadness.

Other: Placebo nasal sprayOther: Film Sequence

Negative placebo group

EXPERIMENTAL

Participants receive a nasal spray that is a placebo. However, they are told that it sensitizes for experiencing negative emotions. Participants watch a film sequence that is supposed to induce sadness.

Other: Placebo nasal sprayOther: Film Sequence

Placebo control group

PLACEBO COMPARATOR

Participants receive a nasal spray that is a placebo and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness.

Other: Placebo nasal sprayOther: Film Sequence

No-treatment control group

OTHER

Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness.

Other: Film Sequence

Interventions

Placebo nasal sprayOTHER
Negative placebo groupPlacebo control groupPositive placebo group
Film SequenceOTHER
Negative placebo groupNo-treatment control groupPlacebo control groupPositive placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • fluent in German language

You may not qualify if:

  • major depression
  • current intake of psychotropic medication
  • drug intake within the last two weeks
  • alcohol consumption within the last twelve hours
  • allergic to capsaicin
  • allergic to sesame oil
  • students in medicine, pharmacy, or psychology in their third year or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps University Marburg

Marburg, Hesse, 35037, Germany

Location

Study Officials

  • Winfried Rief, Professor

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 28, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 6, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)