Influence of Expectations on Rumination
1 other identifier
interventional
90
1 country
1
Brief Summary
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started May 2019
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
May 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2019
CompletedAugust 16, 2019
August 1, 2019
2 months
March 8, 2019
August 15, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (2)
Positive Expectations Group
EXPERIMENTALParticipants 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.
No-treatment control group
NO INTERVENTIONParticipants do not receive the nasal spray.
Interventions
Participants receive an active nasal spray that is in fact a placebo.
Eligibility Criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philipps-Universität Marburg
Marburg, Deutschland, 35032, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Winfried Rief, Professor
Philipps-Univeristy of Marburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 11, 2019
Study Start
May 27, 2019
Primary Completion
July 31, 2019
Study Completion
August 14, 2019
Last Updated
August 16, 2019
Record last verified: 2019-08