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Affect-regulatory Characteristics of Deceptive Placebos

Primary Purpose

Social Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Active Placebo labelled as antidepressant
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Philipps-Universität Marburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group (anticipatory)

Experimental group (reactive)

No-treatment control group

Arm Description

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.

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.

Participants do not receive the nasal spray and continue with the following task.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).

Full Information

First Posted
May 9, 2022
Last Updated
June 22, 2023
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05372744
Brief Title
Affect-regulatory Characteristics of Deceptive Placebos
Official Title
The Influence of Expectations on Affect-regulatory Characteristics of Deceptive Placebos: An Experimental Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (anticipatory)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental group (reactive)
Arm Type
Experimental
Arm Description
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.
Arm Title
No-treatment control group
Arm Type
No Intervention
Arm Description
Participants do not receive the nasal spray and continue with the following task.
Intervention Type
Other
Intervention Name(s)
Active Placebo labelled as antidepressant
Intervention Description
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 Outcome Measure Information:
Title
Change in Experienced Shame (Experienced Shame Scale, 'ESS')
Description
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 Outcome Measure Information:
Title
Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Affect-regulatory Characteristics of Deceptive Placebos

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