Depression Clinical Trial
Official title:
The Influence of Expectations on Affect-regulatory Characteristics of Deceptive Placebos: An Experimental Investigation
NCT number | NCT05372744 |
Other study ID # | Wrief |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2022 |
Est. completion date | July 31, 2022 |
Verified date | June 2023 |
Source | Philipps University Marburg Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study tries to identify whether specifically framed expectations, induced with an active placebo nasal-spray, have effects on affective regulation processes and rumination.
Status | Completed |
Enrollment | 127 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Philipps-Universität Marburg | Marburg |
Lead Sponsor | Collaborator |
---|---|
Philipps University Marburg Medical Center |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Experienced Shame (Experienced Shame Scale, 'ESS') | German questionnaire of 11 items, e.g., physical phenomena: feeling "very warm--- very cold; pale---flushed"; emotional phenomena: feeling "good---bad, clear---confused, calm---highly aroused ", social phenomena: feeling like "hiding---being sociable, talking---being quiet" All Items will be rated on a Likert scale from 1 (= strongly disagree) to 7 (= strongly agree) | At baseline and after autobiographical recall. Each assessment is taking 5 minutes, in total 10 minutes. | |
Secondary | 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 Likert 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. |
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