Influence of Expectations on Rumination
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Active Placebo labelled as antidepessant
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- Philipps-Universität Marburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Positive Expectations Group
No-treatment control group
Arm Description
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.
Participants do not receive the nasal spray.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03869424
First Posted
March 8, 2019
Last Updated
August 15, 2019
Sponsor
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03869424
Brief Title
Influence of Expectations on Rumination
Official Title
Influence of Expectations on Rumination: An Experimental Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
August 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive Expectations Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No-treatment control group
Arm Type
No Intervention
Arm Description
Participants do not receive the nasal spray.
Intervention Type
Other
Intervention Name(s)
Active Placebo labelled as antidepessant
Intervention Description
Participants receive an active nasal spray that is in fact a placebo.
Primary Outcome Measure Information:
Title
Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
Description
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).
Time Frame
At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
Title
Change in Positive and Negative Affect Schedule (PANAS-X)
Description
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).
Time Frame
At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Professor
Organizational Affiliation
Philipps-Univeristy of Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps-Universität Marburg
City
Marburg
State/Province
Deutschland
ZIP/Postal Code
35032
Country
Germany
12. IPD Sharing Statement
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Influence of Expectations on Rumination
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