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NCT05372744 | Completed | Social Anxiety


Affect-regulatory Characteristics of Deceptive Placebos
Sponsor:

Philipps University Marburg Medical Center

Brief 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.

Condition or disease

Social Anxiety

Depression

Intervention/treatment

Active Placebo labelled as antidepressant

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 127 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : The Influence of Expectations on Affect-regulatory Characteristics of Deceptive Placebos: An Experimental Investigation
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022
Arm Intervention/treatment

Experimental: Experimental group (anticipatory)

Participants receive a nasal spray that is in fact a placebo. However, they are told that it protects from experiencing intensive emotional reactions and consequent rumination tendencies. They take the nasal spray once in the laboratory.

Experimental: Experimental group (reactive)

Participants receive a nasal spray that is in fact a placebo. Participants of this group are told, however, that it helps to regulate experienced intensive emotional reactions and to distance oneself from consequent ruminative thoughts. They take the nasal spray once in the laboratory.

No Intervention: No-treatment control group

Participants do not receive the nasal spray and continue with the following task.

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

Affect-regulatory Characteristics of Deceptive Placebos

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Affect-regulatory Characteristics of Deceptive Placebos

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Locations


Not yet recruiting

Germany,

Philipps University of Marburg

Marburg, Germany, 35037

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