Affect-regulatory Characteristics of Deceptive Placebos

Depression Clinical Trial

Official title:

The Influence of Expectations on Affect-regulatory Characteristics of Deceptive Placebos: An Experimental Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372744
• Other study ID #: Wrief
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Social Anxiety

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.