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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04290234
Other study ID # TEDDY
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 17, 2019
Est. completion date June 2020

Study information

Verified date February 2020
Source University Hospital, Bonn
Contact Dirk Scheele, PhD
Phone +49-(0)228-287
Email Dirk.Scheele@ukbonn.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
fMRI assessment of cognitive and reactive fear
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.

Locations

Country Name City State
Germany Department of Psychiatry, University of Bonn Bonn

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bonn Prof. Dean Mobbs

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neural responses in the flight initiation distance (FID) task 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. fMRI paradigm with an average duration of 45 minutes
Primary Flight distance in the flight initiation distance (FID) task 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. fMRI paradigm with an average duration of 45 minutes
Primary Difficulty ratings in the flight initiation distance (FID) task 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. fMRI paradigm with an average duration of 45 minutes
Primary Confidence ratings in the flight initiation distance (FID) task 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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