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Influence of Expectations on Rumination

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ClinicalTrials.gov Identifier: NCT03869424
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Study Description
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Brief Summary:
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.

Condition or disease Intervention/treatment Phase
Depression Other: Active Placebo labelled as antidepessant Not Applicable

Detailed Description:
Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Expectations on Rumination: An Experimental Investigation
Actual Study Start Date : May 27, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : August 14, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Positive Expectations Group
Participants 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.
 Other: Active Placebo labelled as antidepessant
Participants receive an active nasal spray that is in fact a placebo.
No Intervention: No-treatment control group
Participants do not receive the nasal spray.


Outcome Measures
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Primary Outcome Measures :
  1. Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung) [ Time Frame: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes. ]
    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).

  2. Change in Positive and Negative Affect Schedule (PANAS-X) [ Time Frame: At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes. ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • fluent in German language

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869424


Locations
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Germany
Philipps-Universität Marburg
Marburg, Deutschland, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Winfried Rief, Professor Philipps-Univeristy of Marburg
More Information
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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03869424    
Other Study ID Numbers: 2019-05k
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rumination Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Feeding and Eating Disorders
Mental Disorders