Affect-regulatory Characteristics of Deceptive Placebos

Philipps University Marburg127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Social Anxiety Depression

Interventions

Active Placebo labelled as antidepressantOTHER

Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Philipps-Universität Marburg

Marburg, Germany

Outcomes

Primary Outcomes

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)

Time frame: At baseline and after autobiographical recall. Each assessment is taking 5 minutes, in total 10 minutes.

Secondary Outcomes

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).

Time frame: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.

Data from ClinicalTrials.gov

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