Influence of Expectations on Rumination

Depression Clinical Trial

Official title:

Influence of Expectations on Rumination: An Experimental Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869424
• Other study ID #: 2019-05k
• Status: Completed
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: August 14, 2019

Study information

• Verified date: August 2019
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 14, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• Active Placebo labelled as antidepessant
Participants receive an active nasal spray that is in fact a placebo.

Locations

Country	Name	City	State
Germany	Philipps-Universität Marburg	Marburg	Deutschland

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.