Affect-regulatory Characteristics of Deceptive Placebos

Philipps University

Status: Completed

Conditions: Social Anxiety; Depression

Treatments: Other: Active Placebo labelled as antidepressant

Study type: Interventional

Funder types: Other

Identifiers

NCT05372744

Wrief

Details and patient eligibility

About

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

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 3 patient groups

Experimental group (anticipatory)

Experimental group

Description:

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.

Treatment:

Other: Active Placebo labelled as antidepressant

Experimental group (reactive)

Experimental group

Description:

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.

Treatment:

Other: Active Placebo labelled as antidepressant

No-treatment control group

No Intervention group

Description:

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