- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03694574
Emotion Regulation in Trait Schizotypy
October 5, 2018 updated by: Krisztina Kocsis-Bogar, Danube University Krems
Emotion Regulation in Individuals With High and Low Trait Schizotypy. A Randomized Controlled Trial Comparing Suppression and Reappraisal
Our aim is to compare state anger and state emotion regulation strategies in healthy individuals with high trait schizotypy and to look at differences of induced anger, negative emotions, decrease of positive emotions and aggressive behaviour after anger induction.
Our further aim is to compare conditions where an instruction to suppress or reappraise emotions is given with a control condition with no instruction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 18 and 58 years,
- good command of German language
Exclusion Criteria:
- present or past psychiatric or neurological illness,
- ongoing treatment with psychiatric drugs,
- constant consume of heroin or hallucinogenic drugs,
- alcohol dependence,
- cannabis consume two weeks before testing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Low schizotypy
Schizotypy score < 14 measured by the German Version of Schizotypal Personality Questionnaire (Klein, Andresen, & Jahn, 1997)
|
"It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort.
Next, try not to think of the situation that makes you angry, mad or irritated.
Please try as much as you cannot to think about the situation, don't think about how you feel or what had happened, and try to suppress your emotions and not to feel them.
It's very important to try as much as you cannot to think about the situation that makes you angry, mad or irritated."
(Szasz, Szentagothai, & Hoffmann, 2011)
"It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort.
Next, please try to tell yourself that or would be preferable that the others are nice and/or fair to you, but if they are not, it does not mean that you or they are worthless human beings.
It would be preferable that the others be nice and/or fair to you but if they are not, remember that it is only (very) bad), not catastrophic (the worst thing that could happen to you).
It would be preferable that others are nice and/or fair to you, but if they are not, you can tolerate it, and go on enjoying life, even if it's more difficult at the beginning."
(Szasz et al., 2011)
No instruction
|
Other: High schizotypy
Schizotypy score ≥ 14 measured by the German Version of Schizotypal Personality Questionnaire (Klein, Andresen, & Jahn, 1997)
|
"It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort.
Next, try not to think of the situation that makes you angry, mad or irritated.
Please try as much as you cannot to think about the situation, don't think about how you feel or what had happened, and try to suppress your emotions and not to feel them.
It's very important to try as much as you cannot to think about the situation that makes you angry, mad or irritated."
(Szasz, Szentagothai, & Hoffmann, 2011)
"It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort.
Next, please try to tell yourself that or would be preferable that the others are nice and/or fair to you, but if they are not, it does not mean that you or they are worthless human beings.
It would be preferable that the others be nice and/or fair to you but if they are not, remember that it is only (very) bad), not catastrophic (the worst thing that could happen to you).
It would be preferable that others are nice and/or fair to you, but if they are not, you can tolerate it, and go on enjoying life, even if it's more difficult at the beginning."
(Szasz et al., 2011)
No instruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
state anger
Time Frame: 3 minutes
|
measured by the German version of State-Trait Anger Expression Inventory (Schwenkmetzger, Hodapp, & Spielberger, 1992)
|
3 minutes
|
state negative emotions
Time Frame: 3 minutes
|
measured by the German Version of Positive and Negative Affect Schedule (Krohne, Egloff, Kohlmann, & Tausch, 1996)
|
3 minutes
|
state positive emotions
Time Frame: 3 minutes
|
measured by the German Version of Positive and Negative Affect Schedule (Krohne, Egloff, Kohlmann, & Tausch, 1996)
|
3 minutes
|
aggressive behavior
Time Frame: 3 minutes
|
measured by the amount of chili measured by the Hot Sauce Paradigm (Lieberman, Solomon, Greenberg, & McGregor, 1999)
|
3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Klein, C., Andresen, B., & Jahn, T. (1997). Erfassung der schizotypen Persönlichkeit nach DSM-III-R: Psychometrische Eigenschaften einer autorisierten deutschsprachigen Übersetzung des
- Krohne, H. W., Egloff, B., Kohlmann, C. W., & Tausch, A. (1996). Untersuchung mit einer deutschen Form der Positive and Negative Affect Schedule (PANAS). Diagnostica, 42, 139-156.
- Lieberman, J. D., Solomon, S., Greenberg, J. & McGregor, H. A. (1999). A hot new way to measure aggression: hot sauce allocation, Aggressive Behavior, 25, 331-348
- Schwenkmetzger, P., Hodapp, V., & Spielberger, C. D. (1992). Das State-Trait-Ärgerausdrucks-Inventar (STAXI). Bern: Huber.
- Szasz PL, Szentagotai A, Hofmann SG. The effect of emotion regulation strategies on anger. Behav Res Ther. 2011 Feb;49(2):114-9. doi: 10.1016/j.brat.2010.11.011. Epub 2010 Dec 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
September 30, 2017
Study Registration Dates
First Submitted
October 1, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 3, 2018
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- DanubeUK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Interested researchers can request the data from the primary investigator (krisztina.kocsis-bogar@donau-uni.ac.at).
Please give a short description of the study including an explanation about how you are going to use the data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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