Socio-cognitive and Biological Responses to Maltreatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMedical University Innsbruck
About this trial
The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism. However, it is unclear how a history of emotional CM affects psychological and biological outcomes in bipolar disorder (BD). Therefore, this study focuses on understanding how a possible history of CM affects BD compared to control participants (CP) with no known psychiatric illness.
The aim of the project is to investigate how a history of emotional CM is associated with social cognition. The investigators will recruit 80 CP and 80 people diagnosed with BD, some of whom will have a history of CM. The investigators will assess psychological well-being (social behaviour, empathy) at two points in time at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology at the Medical University of Innsbruck (MUI). Additionally, as they want to understand how emotional CM affects brain function and structure, the investigators will perform magnetic resonance imaging (MRI) of the brain at the Neuroimaging Core Facility (Medical University of Innsbruck). The investigators also want to understand how biological markers in the blood (such as telomere length, inflammation) might be affected, assessed in collaboration with the Department of Psychology (Leopold-Franzens University of Innsbruck). Finally, the investigators will look at a combination of the psychological and biological tests to see if there is a link between emotional CM and health outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
diagnosis of a moderate to severe depressive episode without psychotic features in the context of BD-I according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5: 296.52 BD-I, most recent episode depressed, moderate; 296.53 BD-I, most recent episode depressed, severe without psychotic features;
Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20;
age between 18 and 65 years; and
able to provide written informed consent for magnetic resonance imaging (MRI) and study participation.
Disqualifiers
a history of one or more diagnoses of the following DSM-5 categories: past or current moderate or severe substance dependence (303.x, 304.x, 305.x) with the exclusion of tobacco use disorder (305.1), neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x), schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x), neurocognitive disorders (290.x, 292.x, 294.x, 331.x), BD-I Single Manic (296.0x), BD-I Manic (296.4x), BD-I Mixed (296.6, 296.7, 296.8, 296.9), BD-II (296.89), or comorbid Borderline Personality Disorder (BPD) as assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD);
a current episode of illness with psychotic features (296.54);
a recent history of central nervous system (CNS) trauma or significant CNS trauma;
physical illness that might interfere with the participant's cognitive performance;
Trial population
For bipolar disorder with a current diagnosis of depressive episode: Inpatient clinic of the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology of the Medical University Innsbruck. For healthy controls: recruitment is done via public advertisements (e.g. posters, flyers, local newspaper announcements) and at the homepage of Medical University Innsbruck, Tirol Kliniken, and University of Innsbruck.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 2 trial groupsGroup A: Bipolar 1 disorder
Group B: Control subjects
Trial outcomes
Primary outcomes
1
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure; MACE-X) and emotion recognition of adult faces (Reading the Mind in the Eyes Test; RMET)
Correlation between a history of emotional childhood maltreatment score (as assessed by a combined score of the Maltreatment and Abuse Chronology of Exposure \[MACE-X\] emotional subscales: parental verbal abuse, parental nonverbal emotional abuse, emotional neglect, peer verbal abuse) and emotion recognition (number of correctly identified emotions) as assessed by the Reading the Mind in the Eyes Test adult version (RMET). RMET use expressions from images of 28 adult faces, 50% male and 50% female. The task consist of two types of trials: emotion recognition and sex judgment. In the emotion recognition trials, participants select among four adjectives the one that best describes what the person in the image is thinking or feeling. This task is sensitive to subtle emotion processing deficits since it involves the recognition of a relatively wide range of complex mental states.
Time frame
In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.2
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and emotion recognition of child faces (Reading the Mind in the Eyes Test; RME-C-T)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and emotion recognition (number of correctly identified emotions) as assessed the Reading the Mind in the Eyes Test child version (RME-C-T). RME-C-T uses high-quality pictures of 28 child faces. The task consist of two types of trials: emotion recognition and sex judgment. In the emotion recognition trials, participants select among four adjectives the one that best describes what the person in the image is thinking or feeling.
Time frame
In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.3
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and cognitive empathy (Multifaceted Empathy Test; MET-core 2)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and cognitive empathy (number of correctly identified) as assessed by The Multifaceted Empathy Test (MET-core 2). MET-core 2 is an ecologically valid measure that allows separate assessment of cognitive and affective empathy. It consists of 40 photographs depicting people in emotionally charged situations and is designed to elicit strong emotional reactions. To assess cognitive empathy ("What is the person feeling?"), the mental states of the people in the photographs are selected from four mental state descriptors. To assess affective empathy ("How much are you feeling for the person?"), the level of empathic concern for the depicted individuals is rated on a 4-point Likert scale (from "not at all" to "very strong") for the same series of pictures.
Time frame
In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.4
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and affective empathy (Multifaceted Empathy Test; MET-core 2)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and affective empathy (rating) as assessed by The Multifaceted Empathy Test (MET-core 2). MET-core 2 is an ecologically valid measure that allows separate assessment of cognitive and affective empathy. It consists of 40 photographs depicting people in emotionally charged situations and is designed to elicit strong emotional reactions. To assess cognitive empathy ("What is the person feeling?"), the mental states of the people in the photographs are selected from four mental state descriptors. To assess affective empathy ("How much are you feeling for the person?"), the level of empathic concern for the depicted individuals is rated on a 4-point Likert scale for the same series of pictures.
Time frame
In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.Secondary outcomes
1
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain morphometry (T1-weighted imaging)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain morphometry (T1-weighted MRI). The research hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with small limbic volumes (e.g. hippocampi, amygdala, thalamus). These changes in morphometry will be more pronounced in bipolar disorder compared to control participants.
Time frame
At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.2
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain responses (task-based fMRI)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain responses (task-based functional MRI). In control participant, the hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with: i) low brain responses during RMET/RME-C-T (along with correct and rapid identification of negative emotions) in social cognitive brain regions (e.g. temporoparietal junction, medial prefrontal cortex, amygdala, insula); ii) high brain responses during MET-Core 2 (along with high cognitive and affective empathy abilities). In bipolard disorder, increasing severity of a history of emotional childhood maltreatment will correlate with: i) high brain responses during RMET/RME-C-T in social cognitive regions (along with incorrect and slow identification of negative emotions) ii) low brain responses during MET-Core 2 (along with low cognitive and affective empathy abilities).
Time frame
At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.3
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain functional connectivity (resting-state functional MRI).
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain functional connectivity (resting-state functional MRI). The hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate low functional connectivity within the Theory-of-Mind (ToM) network. These changes in functional connectivity will be more pronounced in bipolar disorder compared to control participants. Both cognitive and affective ToM tasks involve the posterior temporoparietal junction, the posterior superior temporal sulcus, and the posterior cingulate cortex. While cognitive ToM involves the dorsolateral prefrontal cortex (PFC), dorsal striatum, dorsal anterior cingulate cortex (ACC), and dorsomedial PFC, affective ToM involves the inferior frontal gyrus, insula, ventral striatum, amygdala, temporal poles, ACC, and medial PFC.
Time frame
At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.4
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain white matter values (diffusion MRI)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain white matter values (diffusion MRI). The hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with disruption (e.g. low fractional anisotropy values) in white matter tracts connecting social cognitive regions (e.g. superior longitudinal fasciculus, cingulum, uncinate fasciculus, corpus callosum). These changes in white matter will be more pronounced in bipolar disorder compared to control participants.
Time frame
At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.Other outcomes
1
Illness effects and stability of self-reported childhood maltreatment assessment
Change in the baseline and follow-up (3 to 6 months) assessments of self-reported childhood maltreatment (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) data are used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame
Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.2
Illness effects and stabilitity of emotion recognition (RME-C-T)
Change in the baseline and follow-up (3 to 6 months) assessment of emotion recognition (number of correctly identified emotions) as assessed the Reading the Mind in the Eyes Test child version (RME-C-T) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame
Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.3
Illness effects and stabilitity of emotion recognition (RMET)
Change in the baseline and follow-up (3 to 6 months) assessment of emotion recognition (number of correctly identified emotions) as assessed by the Reading the Mind in the Eyes Test adult version (RMET) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame
Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.4
Illness effects and stabilitity of cognitive empathy (MET-core 2)
Change in the baseline and follow-up (3 to 6 months) assessment of cognitive empathy (number of correctly identified) as assessed by The Multifaceted Empathy Test (MET-core 2) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame
Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University Innsbruck
Lead sponsor
Medical School Hamburg
Collaborator
University of Innsbruck, Austria
Collaborator
Source ClinicalTrials.gov