Depression
Conditions
Brief summary
The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.
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.
Interventions
OTHERActive Placebo labelled as antidepessant
Participants receive an active nasal spray that is in fact a placebo.
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| Change in Positive and Negative Affect Schedule (PANAS-X) | 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). |
Countries
Germany
Outcome results
None listed