- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04290234
Childhood Trauma and Escape Decision Dynamics (TEDDY)
February 26, 2020 updated by: Rene Hurlemann, University Hospital, Bonn
The Influence of Childhood Maltreatment on Cognitive and Reactive Fear
The purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Childhood maltreatment dramatically increases the risk for psychiatric disorders accompanied by profound difficulties in social interactions.
However, it is still unclear how childhood maltreatment affects social interactions in adulthood.
In this study, we examine how childhood maltreatment may modulate threat sensitivity assessed by the distance at which an individual flees from an approaching threat.
While rapid escape decisions rely on "reactive fear" circuits, slower escape decisions are associated with "cognitive fear" circuits.
Based on previous observations of altered early sensory processing, we expect that childhood maltreatment affects both cognitive and reactive fear circuits.
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dirk Scheele, PhD
- Phone Number: 11151 +49-(0)228-287
- Email: Dirk.Scheele@ukbonn.de
Study Locations
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Bonn, Germany, 53105
- Recruiting
- Department of Psychiatry, University of Bonn
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Contact:
- Rene Hurlemann, MSc MD PhD
- Email: Rene.Hurlemann@ukbonn.de
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Contact:
- Dirk Scheele, PhD
- Email: Dirk.Scheele@ukb.uni-bonn.de
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Principal Investigator:
- Rene Hurlemann, MSc, MD, PhD
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Sub-Investigator:
- Dirk Scheele, PhD
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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
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from a community sample and childhood maltreatment will be assessed with the Childhood Trauma Questionnaire.
Description
Inclusion Criteria:
- Healthy subjects with varying levels of childhood maltreatment
Exclusion Criteria:
- current psychiatric illness
- current psychiatric medication or psychotherapy
- MRI contraindication (e.g. metal in body, claustrophobia)
- pregnancy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-medicated healthy adults with childhood maltreatment
The 25-item retrospective Childhood Trauma Questionnaire (CTQ) will be administered to assess history of abuse and neglect.
The CTQ measures five types of maltreatment: emotional, physical, and sexual abuse and emotional and physical neglect.
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An fMRI paradigm will be used to probe how childhood maltreatment may modulate the defensive survival circuitry that facilitates escape decisions when subjects encounter fast- or slow-attacking threats.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural responses in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
|
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in a flight initiation distance (FID) task, involving fast-, medium- and slow-attacking virtual predators that elicit distinct activations in the reactive and cognitive fear circuits.
Blood-oxygen-level-dependent signals to different predator velocities will be analyzed.
Analyses will focus on regions-of-interest associated with the processing of cognitive fear (ventromedial prefrontal cortex, posterior cingulate cortex, hippocampus, and basolateral amygdala) and reactive fear (midbrain periaqueductal gray, central amygdala, hypothalamus, and the midcingulate cortex).
To examine effects of childhood maltreatment, regression analyses with Childhood Trauma Questionnaire scores will be conducted on the second level.
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fMRI paradigm with an average duration of 45 minutes
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Flight distance in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
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Associations between the flight distance in the FID task and childhood maltreatment will be analyzed using regression analyses with Childhood Trauma Questionnaire scores.
Behavioral data will be correlated with fMRI data of the FID task.
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fMRI paradigm with an average duration of 45 minutes
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Difficulty ratings in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
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Associations between the difficulty ratings in the FID task and childhood maltreatment will be analyzed using regression analyses with Childhood Trauma Questionnaire scores.
Behavioral data will be correlated with fMRI data of the FID task.
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fMRI paradigm with an average duration of 45 minutes
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Confidence ratings in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
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Associations between the confidence ratings in the FID task and childhood maltreatment will be analyzed using regression analyses with Childhood Trauma Questionnaire scores.
Behavioral data will be correlated with fMRI data of the FID task.
|
fMRI paradigm with an average duration of 45 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dirk Scheele, PhD, University of Bonn
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)
November 17, 2019
Primary Completion (ANTICIPATED)
June 1, 2020
Study Completion (ANTICIPATED)
June 1, 2020
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
February 26, 2020
First Posted (ACTUAL)
February 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TEDDY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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