Influence of Expectations on Rumination

Philipps University Marburg90 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Active Placebo labelled as antidepessantOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Philipps-Universität Marburg

Marburg, Deutschland, Germany

Outcomes

Primary Outcomes

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).

Time frame: 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).

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

Data from ClinicalTrials.gov

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