Trait SchizotypyNCT03694574
Emotion Regulation in Trait Schizotypy
A study testing instruction to suppress and instruction to reappraise in people with Trait Schizotypy, run by Danube University Krems.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Trait Schizotypy
- What is being tested?
- instruction to suppress and instruction to reappraise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 58 years,
- good command of German language
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Trait Schizotypy
- Being tested
- instruction to suppress, instruction to reappraise, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instruction to suppressBehavioural
"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)
instruction to reappraiseBehavioural
"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)
controlBehavioural
No instruction
| Study group | Role | What they receive |
|---|---|---|
| Low schizotypy | Other | Schizotypy score < 14 measured by the German Version of Schizotypal Personality Questionnaire (Klein, Andresen, \& Jahn, 1997) Receives: Behavioral: instruction to suppress; Behavioral: instruction to reappraise; Behavioral: control |
| High schizotypy | Other | Schizotypy score ≥ 14 measured by the German Version of Schizotypal Personality Questionnaire (Klein, Andresen, \& Jahn, 1997) Receives: Behavioral: instruction to suppress; Behavioral: instruction to reappraise; Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
state anger
measured by the German version of State-Trait Anger Expression Inventory (Schwenkmetzger, Hodapp, \& Spielberger, 1992)
Measured: 3 minutes
state negative emotions
measured by the German Version of Positive and Negative Affect Schedule (Krohne, Egloff, Kohlmann, \& Tausch, 1996)
Measured: 3 minutes
state positive emotions
measured by the German Version of Positive and Negative Affect Schedule (Krohne, Egloff, Kohlmann, \& Tausch, 1996)
Measured: 3 minutes
aggressive behavior
measured by the amount of chili measured by the Hot Sauce Paradigm (Lieberman, Solomon, Greenberg, \& McGregor, 1999)
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Mar 2016
- Primary completion31 May 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trait SchizotypyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danube University Krems
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Principal investigator, Krisztina Kocsis-Bogar, Danube University Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694574
- Sponsor's protocol ID
- DanubeUK
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 21185551
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation in Individuals With High and Low Trait Schizotypy. A Randomized Controlled Trial Comparing Suppression and Reappraisal
- ClinicalTrials.gov ID
- NCT03694574
- Acronym / sponsor ID
- DanubeUK
- Conditions
- Trait Schizotypy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Danube University KremsUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low schizotypy | Other | Behavioral: instruction to suppress, Behavioral: instruction to reappraise, Behavioral: controlSchizotypy score < 14 measured by the German Version of Schizotypal Personality Questionnaire (Klein, Andresen, \& Jahn, 1997) |
| High schizotypy | Other | Behavioral: instruction to suppress, Behavioral: instruction to reappraise, Behavioral: controlSchizotypy score ≥ 14 measured by the German Version of Schizotypal Personality Questionnaire (Klein, Andresen, \& Jahn, 1997) |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 58 years,
- good command of German language
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instruction to suppress"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) | Behavioural | High schizotypy, Low schizotypy |
| instruction to reappraise"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) | Behavioural | High schizotypy, Low schizotypy |
| controlNo instruction | Behavioural | High schizotypy, Low schizotypy |
Primary outcome
state anger
Time frame: 3 minutes
measured by the German version of State-Trait Anger Expression Inventory (Schwenkmetzger, Hodapp, \& Spielberger, 1992)
state negative emotions
Time frame: 3 minutes
measured by the German Version of Positive and Negative Affect Schedule (Krohne, Egloff, Kohlmann, \& Tausch, 1996)
state positive emotions
Time frame: 3 minutes
measured by the German Version of Positive and Negative Affect Schedule (Krohne, Egloff, Kohlmann, \& Tausch, 1996)
aggressive behavior
Time frame: 3 minutes
measured by the amount of chili measured by the Hot Sauce Paradigm (Lieberman, Solomon, Greenberg, \& McGregor, 1999)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- BackgroundKlein, C., Andresen, B., & Jahn, T. (1997). Erfassung der schizotypen Persönlichkeit nach DSM-III-R: Psychometrische Eigenschaften einer autorisierten deutschsprachigen Übersetzung des
- BackgroundKrohne, 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.
- BackgroundLieberman, 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
- BackgroundSchwenkmetzger, P., Hodapp, V., & Spielberger, C. D. (1992). Das State-Trait-Ärgerausdrucks-Inventar (STAXI). Bern: Huber.
- Background: PubMed 21185551Szasz 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.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing instruction to suppress and instruction to reappraise in people with Trait Schizotypy, run by Danube University Krems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
state anger (time frame: 3 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694574, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.