Affect-regulatory Characteristics of Deceptive Placebos

NCT05372744 | Completed

• 1 other identifier: Wrief
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

Study Arms (3)

Experimental group (anticipatory)

EXPERIMENTAL

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

Experimental group (reactive)

EXPERIMENTAL

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

No-treatment control group

NO INTERVENTION

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

Interventions

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.

Experimental group (anticipatory); Experimental group (reactive)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers
• fluent in German language

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps-Universität Marburg

Marburg, 35037, Germany

Location

Related Publications (1)

• Schafer LN, Rief W. The influence of expectations on shame, rumination and cognitive flexibility: an experimental investigation on affect-regulatory characteristics of deceptive placebos. Front Psychol. 2025 Jan 10;15:1502460. doi: 10.3389/fpsyg.2024.1502460. eCollection 2024.

  PMID: 39868023 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: May 25, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)