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OpenTrials
Completed

NCT Number: NCT03869424

Influence of Expectations on Rumination

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps-Universität Marburg

Marburg, Deutschland, 35032, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Placebo labelled as antidepessant

Other

Participants receive an active nasal spray that is in fact a placebo.

Primary outcomes

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

    Time frame: 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 visual analogue scale from 0 (not at all) to 10 (very much).

  2. Change in Positive and Negative Affect Schedule (PANAS-X)

    Time frame: At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.

    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).

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Influence of Expectations on Rumination: An Experimental Investigation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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