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Effects of Emotional Stimulation on the Stress Levels of Healthy Persons

Primary Purpose

Depression, Somatization Disorder, Anger

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Emotional stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 to 45
  • Ability to speak German

Exclusion Criteria:

  • Physical or psychiatric disorders
  • Consume of drugs or alcohol 24 previous to the test

Sites / Locations

  • Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Depression
Depression scores will be evaluated with the BDI
Somatization
Somatization will be assessed with the SOMS7 questionnaire

Secondary Outcome Measures

Full Information

First Posted
August 9, 2010
Last Updated
October 22, 2010
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01187797
Brief Title
Effects of Emotional Stimulation on the Stress Levels of Healthy Persons
Official Title
Evaluation of the Effects of a Body-centered Emotional Stimulation in Healthy Persons
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.
Detailed Description
The trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. The outcomes will be evaluated with standard questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Somatization Disorder, Anger, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Emotional stimulation
Intervention Description
Increase of the physical correlates of an emotion
Primary Outcome Measure Information:
Title
Depression
Description
Depression scores will be evaluated with the BDI
Time Frame
After 10 days
Title
Somatization
Description
Somatization will be assessed with the SOMS7 questionnaire
Time Frame
After 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 to 45 Ability to speak German Exclusion Criteria: Physical or psychiatric disorders Consume of drugs or alcohol 24 previous to the test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fernando Dimeo, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

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Effects of Emotional Stimulation on the Stress Levels of Healthy Persons

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