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Completed

NCT Number: NCT05372744

Affect-regulatory Characteristics of Deceptive Placebos

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

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Key information

Conditions

Social Anxiety Behavior Behavioral Symptoms Depression

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps-Universität Marburg

Marburg, 35037, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Experienced Shame (Experienced Shame Scale, 'ESS')

    Time frame: 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 outcomes

  1. Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 13, 2022
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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