Affect-regulatory Characteristics of Deceptive Placebos

• Sponsor: Philipps University Marburg Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05372744
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 4.2
• Patients Per Site Per Month: 28.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety; Depression	Other: Active Placebo labelled as antidepressant	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Influence of Expectations on Affect-regulatory Characteristics of Deceptive Placebos: An Experimental Investigation
• Anticipated Study Start Date: May 25, 2022
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group (anticipatory) 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; Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.
Experimental: Experimental group (reactive) 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; Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.
No Intervention: No-treatment control group Participants do not receive the nasal spray and continue with the following task.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Philipps-Universität Marburg	Marburg		Germany	35037

Sponsors and Collaborators

• Philipps University Marburg Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philipps University Marburg Medical Center
• ClinicalTrials.gov Identifier: NCT05372744
• Other Study ID Numbers: Wrief
• First Posted: May 13, 2022
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Antidepressive Agents

Study Results

No Results Posted as of May 13, 2022