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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Recruiting
        • Department of Psychiatry, University of Bonn
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rene Hurlemann, MSc, MD, PhD
        • Sub-Investigator:
          • Dirk Scheele, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
fMRI paradigm with an average duration of 45 minutes
Flight distance in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
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
Difficulty ratings in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
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
Confidence ratings in the flight initiation distance (FID) task
Time Frame: fMRI paradigm with an average duration of 45 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bonn

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prof. Dean Mobbs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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