Affect-regulatory Characteristics of Deceptive Placebos
- Conditions
- DepressionSocial Anxiety
- Interventions
- Other: Active Placebo labelled as antidepressant
- Registration Number
- NCT05372744
- Lead 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- healthy volunteers
- fluent in German language
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group (anticipatory) Active Placebo labelled as antidepressant 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 group (reactive) Active Placebo labelled as antidepressant 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.
- Primary Outcome Measures
Name Time Method Change in Experienced Shame (Experienced Shame Scale, 'ESS') At baseline and after autobiographical recall. Each assessment is taking 5 minutes, in total 10 minutes. 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)
- Secondary Outcome Measures
Name Time Method Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung) At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes. 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).
Trial Locations
- Locations (1)
Philipps-UniversitÀt Marburg
đ©đȘMarburg, Germany