Influence of Expectations on Rumination

Influence of Expectations on Rumination: An Experimental Investigation

The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Active Placebo labelled as antidepessant

Detailed Description

Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Deutschland
    • Marburg, Deutschland, Germany, 35032
      • Philipps-Universitat Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Expectations Group; Participants receive a nasal spray that is in fact a placebo. However, they are told that it protects from rumination. They take the nasal spray once in the laboratory.	Other: Active Placebo labelled as antidepessant; Participants receive an active nasal spray that is in fact a placebo.
No Intervention: No-treatment control group; Participants do not receive the nasal spray.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 visual analogue scale from 0 (not at all) to 10 (very much).	At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
Change in Positive and Negative Affect Schedule (PANAS-X)	Items of PANAS-X: Sadness Score ("sad", "blue", "downhearted", "alone", "lonely") and Items "Surprised", "concentrating", "happy". All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much).	At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Professor, Philipps-Univeristy of Marburg

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Feeding and Eating Disorders; Gastrointestinal Diseases; Rumination Syndrome
• Other Study ID Numbers: 2019-05k

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No