Child AbuseTEDDYNCT04290234
Childhood Trauma and Escape Decision Dynamics
An observational study of Child Abuse and Fear, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Abuse, Fear
- What is being tested?
- fMRI assessment of cognitive and reactive fear
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2019to Jun 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from a community sample and childhood maltreatment will be assessed with the Childhood Trauma Questionnaire.
Who may be able to join
- Healthy subjects with varying levels of childhood maltreatment
Who cannot join
- current psychiatric illness
- current psychiatric medication or psychotherapy
- MRI contraindication (e.g. metal in body, claustrophobia)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry, University of Bonn
Bonn, 53105
Rene Hurlemann, MSc MD PhD, Rene.Hurlemann@ukbonn.de
Dirk Scheele, PhD, Dirk.Scheele@ukb.uni-bonn.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Abuse, Fear
- Being tested
- fMRI assessment of cognitive and reactive fear
- Keywords
- cognitive fear, fMRI, reactive fear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI assessment of cognitive and reactive fearOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: fMRI assessment of cognitive and reactive fear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: fMRI paradigm with an average duration of 45 minutes
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.
Measured: fMRI paradigm with an average duration of 45 minutes
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.
Measured: fMRI paradigm with an average duration of 45 minutes
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.
Measured: fMRI paradigm with an average duration of 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start17 Nov 2019
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dean Mobbs
- Responsible party
- Principal investigator, Rene Hurlemann, University of Oldenburg
- Investigators
- Dirk Scheele, PhD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290234
- Sponsor's protocol ID
- TEDDY
- Acronym
- TEDDY
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Childhood Maltreatment on Cognitive and Reactive Fear
- ClinicalTrials.gov ID
- NCT04290234
- Acronym / sponsor ID
- TEDDY / TEDDY
- Conditions
- Child Abuse, Fear
- Keywords
- cognitive fear, fMRI, reactive fear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Prof. Dean Mobbs
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 28 Feb 2020 (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.
The purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-medicated healthy adults with childhood maltreatment | – | Other: fMRI assessment of cognitive and reactive fearThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from a community sample and childhood maltreatment will be assessed with the Childhood Trauma Questionnaire.
Key inclusion criteria (1 listed)
- Healthy subjects with varying levels of childhood maltreatment
Key exclusion criteria (4 listed)
- current psychiatric illness
- current psychiatric medication or psychotherapy
- MRI contraindication (e.g. metal in body, claustrophobia)
- pregnancy
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 |
|---|---|---|
| fMRI assessment of cognitive and reactive fearAn 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. | Other | Non-medicated healthy adults with childhood maltreatment |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Dirk Scheele, PhD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Abuse and Fear, run by University Hospital, Bonn at 1 site in Germany.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Scheele, PhD (+49-(0)228-287 ext. 11151, Dirk.Scheele@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural responses in the flight initiation distance (FID) task (time frame: fMRI paradigm with an average duration of 45 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?
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 28 Feb 2020.