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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2023
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study tries to identify whether specifically framed expectations, induced with an active placebo nasal-spray, have effects on affective regulation processes and rumination.


Description:

Healthy volunteers are informed that a new application method for an antidepressant, specialized on positively influencing the experience of aversive emotional states would be tested. They will randomly be assigned to a no treatment control group (not taking a placebo) or to one of the two treatment groups: Participants will be taking the antidepressant (which is in fact an active placebo) which will either protect them from experiencing intense emotional reactions and rumination (anticipatory group) or help them to regulate emotional states quicker as well as to distance themselves from ruminative thoughts (reactive group). Then, an aversive emotional state is induced by an autobiographical recall of events which made the participants feel inadequate, bashful, and ashamed. Currently experienced shame as well as state rumination are assessed before and after the negative recall task.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active Placebo labelled as antidepressant
Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.

Locations

Country Name City State
Germany Philipps-Universität Marburg Marburg

Sponsors (1)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

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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