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The study tries to identify whether specifically framed expectations, induced with an active placebo nasal-spray, have effects on affective regulation processes and rumination.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (anticipatory) | Experimental | 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. |
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| Experimental group (reactive) | Experimental | 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-treatment control group | No Intervention | Participants do not receive the nasal spray and continue with the following task. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Placebo labelled as antidepressant | Other | Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps-Universität Marburg | Marburg | 35037 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39868023 | Derived | Schafer LN, Rief W. The influence of expectations on shame, rumination and cognitive flexibility: an experimental investigation on affect-regulatory characteristics of deceptive placebos. Front Psychol. 2025 Jan 10;15:1502460. doi: 10.3389/fpsyg.2024.1502460. eCollection 2024. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| D020164 | Chemical Actions and Uses |