Influence of Expectations on Rumination

Philipps University

Status: Completed

Conditions: Depression

Treatments: Other: Active Placebo labelled as antidepessant

Study type: Interventional

Funder types: Other

Identifiers

NCT03869424

2019-05k

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Positive Expectations Group

Experimental group

Description:

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.

Treatment:

Other: Active Placebo labelled as antidepessant

No-treatment control group

No Intervention group

Description:

Participants do not receive the nasal spray.