Trial document




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  DRKS00015182

Trial Description

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Title

How do adverse childhood experiences and psychiatric disorders impact social cognition?

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Trial Acronym

GRK2350_ACE

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URL of the Trial

http://grk2350.de/index.php/researchfoci (Projekt C1: Comorbidities)

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Brief Summary in Lay Language

Adverse childhood experiences such as abuse and neglect in childhood and adolescence constitute not only massive acute stressors. They can also have long-lasting adverse effects on psychological and somatic health in adulthood. We know from previous studies that individuals with adverse childhood experiences have a significantly higher risk of suffering from psychiatric disorders at some point in their lives. This applies amongst others to major depression, posttraumatic stress disorder and somatic symptom disorder, three disorders with high comorbidities among each other.
But not all individuals with a history of adverse childhood experiences suffer from psychiatric disorders. Nevertheless, these experiences can leave “scars”, meaning that an individual becomes particularly sensitive to certain information. We already know that individuals with adverse childhood experiences are for example very sensitive to interpersonal cues and tend to react very fast to negative facial expressions of other people.
In the present study we want to examine the effects of adverse childhood experiences on social cognition more precisely. We are especially interested in general changes in the processing of and reaction towards interpersonal information after adverse childhood experiences. Additionally, we want to investigate to what extent individuals with and without adverse childhood experiences and major depression, posttraumatic stress disorder or somatic symptom disorder differ from individuals without such a psychiatric disorder in terms of processing of and reaction towards interpersonal information. For this purpose we will employ psychological (questionnaires, interviews, behavioral measures) as well as neuroscientific methods (magnetic resonance imaging).
We hope that this study brings new findings about the difficulties of individuals with adverse childhood experiences. Of special interest is, if certain difficulties only emerge with certain psychiatric disorders. This offers a promising starting point to develop new and specific therapeutic interventions in the context of adverse childhood experiences.

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Brief Summary in Scientific Language

Adverse childhood experiences are seen as the most important singular predictor for psychiatric disorders, which are associated with enormous costs for the society as a whole. One reason might be that adverse childhood experiences lead to massive changes in the processing of social cues. Nevertheless, up to now, there are only few studies investigating shared and diagnosis-specific effects of adverse childhood experiences on social cognition.
In the present study we therefore intend to investigate the effects of adverse childhood experiences on social cognition in several experiments in patients with current posttraumatic stress disorder, somatic symptom disorder or major depression. These disorders are highly prevalent and occur frequently in the sequelae of adverse childhood experiences. In addition these disorders show high degrees of comorbidity among each other. Social cognitive capacities will be examined using validated behavioral tasks, covering threat sensitivity, reward processing and theory of mind. Besides behavioral measures, the underlying neural correlates will be assessed using functional magnetic resonance imaging. Additionally, the connection between type and intensity of adverse childhood experiences, measures of inter- and intrapersonal emotion regulation as well as indicators of interoception will be investigated in an exploratory data analysis.
The present study allows gaining important insights into the mechanisms underlying adverse childhood experiences in three highly prevalent clinical groups of patients. This offers a promising starting point to develop effective, transdiagnostic interventions in the context of adverse childhood experiences. Additionally, we will recruit a healthy control group.

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Organizational Data

  •   DRKS00015182
  •   2018/07/26
  •   [---]*
  •   yes
  •   Approved
  •   S-328/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.0 -  Recurrent depressive disorder, current episode mild
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
  •   DSM-IV 309.81 Posttraumatic Stress Disorder, DSM-IV 296.2x/296.3x Major Depressive Disorder, DSM-5 300.82 Somatic Symptom Disorder
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Interventions/Observational Groups

  •   Patients with posttraumatic stress disorder (n = 45), somatic symptom disorder (n = 45) and depression (n = 45) as well as healthy controls (n = 45) will participate in a comprehensive clinical diagnostic together with different experimental tasks in the laboratory and in an fMRI scanner.
    Appointment 1 - diagnostics: Before their participation, all patients and all healthy controls receive detailed verbal and written information about the whole process and extent of the study. Furthermore, all patients and all healthy controls take part in an exact clinical (exclusion) diagnostic, comprising SCID-I interview, SCID-5 interview and IPDE criteria for borderline personality disorder. Type and intensity of adverse childhood experiences of all patients and all healthy controls will be assessed using three validated diagnostic instruments, two questionnaires and one interview. Additionally, dimensional diagnostic instruments are used to assess symptoms of major depression, posttraumatic symptom disorder and somatic symptom disorder, emotion regulation strategies and severity of general psychopathological symptoms.
    Appointment 2 - Behavioral experiments: At this appointment all patients and all healthy controls participate in three behavioral experiments. Experiment 1 (Eye-Tracking): Eye movements in reaction to facial emotional expressions are recorded. Experiment 2: Participants are presented with a 15 minute movie about four characters communicating with each other. Participants are asked to answer multiple-choice-questions concerning the characters’ emotions (affective theory of mind) as well as thoughts and intentions (cognitive theory of mind). Experiment 3 (ECG): This is a cardiac interoception task.
    Appointment 4 – fMRI: At this appointment all patients and all healthy controls participate in three experiments in an fMRI-scanner while their brain (blood oxygenation level dependent) response is recorded. Experiment 1: Three emotional faces are shown simultaneously (fearful, angry or happy), while participants have to decide, which of the two faces at the bottom is similar to the target face at the top. Experiment 2: Participants are required to press a target button as fast as possible as soon as a cued target symbol (yellow flash) is presented. The cues announce different rewarding stimuli. Experiment 3: Participants are presented with short videos, which differ with regard to their emotionality and requirements to theory of mind. After each video, participants are asked to answer questions concerning their wellbeing and the contents of the videos.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Interaction effect (intensity of adverse childhood experiences x functional domain): Patients and healthy controls with high intensity of adverse childhood experiences show a threat hypersensitivity, a diminished reward sensitivity and a reduced theory of mind capacity compared to patients and healthy controls with low intensity of adverse childhood experiences.
Measurements will be taken on one day.

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Secondary Outcome

cardiac interoception capacity, measured with the subjectively counted heart beats and the electrocardiographic activity.
Measurements will be taken on the same day as the primary outcomes are measured.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/09/14
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

For patients: posttraumatic stress disorder, somatic symptom disorder or major depression as first lifetime and still current diagnosis. For healthy controls: no current and no past psychiatric Axis-I disorder

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Exclusion Criteria

For patients: unable to consent, pregnancy, psychotropic medication with the exception of SSRIs and SSNRIs, current/past bipolar I disorder or schizophrenia, current/ past epilepsy, known brain traumata, brain tumor or other significant neurological/ medical factors, substance addiction during the last two years prior to study admission, current substance abuse, left handedness. For healthy controls: unable to consent, pregnancy, psychotropic medication, current/ past epilepsy, known brain traumata, brain tumor or other significant neurological/ medical factors, substance addiction during the last two years prior to study admission, current substance abuse, left handedness

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Addresses

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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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