Influence of Expectations on Rumination

NCT ID: NCT03869424

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2019-08-14

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive Expectations Group

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.

Group Type: EXPERIMENTAL

Active Placebo labelled as antidepessant

Intervention Type: OTHER

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

No-treatment control group

Participants do not receive the nasal spray.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active Placebo labelled as antidepessant

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Winfried Rief, Professor

Role: PRINCIPAL_INVESTIGATOR

Philipps-Univeristy of Marburg

Locations

Philipps-Universität Marburg

Marburg, Deutschland, Germany

Countries

Germany

Other Identifiers

2019-05k

Identifier Type: -

Identifier Source: org_study_id