Affect-regulatory Characteristics of Deceptive Placebos

Study Overview
=================
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.

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

Conditions
-----------------
Depression, Social Anxiety

Intervention / Treatment
-----------------
* Other: Active Placebo labelled as antidepressant


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (anticipatory)<br>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. | Other: Active Placebo labelled as antidepressant<br>* Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.<br>|
| Experimental: Experimental group (reactive)<br>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. | Other: Active Placebo labelled as antidepressant<br>* Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.<br>|
| No Intervention: No-treatment control group<br>Participants do not receive the nasal spray and continue with the following task. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |