Socio-cognitive and Biological Responses to Maltreatment

NCT07101107 | Not Yet Recruiting DMC

• 2 other identifiers: 1410/202010.55776/KLP7245424
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar 1 Disorder; Control Subjects

Keywords

childhood maltreatment; Social Cognition; empathy; Bipolar Disorder; Biomolecules; Magnetic Resonance Imaging; Theory Of Mind; telomere length; mitochondria; benevolent childhood experiences; trauma; positive childhood experiences; inflammatory markers

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

• 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.

  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.

• 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.

  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.

• 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.

  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 (7)

• Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain morphometry (T1-weighted imaging)

  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.

• Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain responses (task-based fMRI)

  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.

• 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).

  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.

• 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)

  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.

• Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and inflammation

  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.

Other Outcomes (25)

• Illness effects and stability of self-reported childhood maltreatment assessment

  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.

• Illness effects and stabilitity of emotion recognition (RME-C-T)

  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.

• Illness effects and stabilitity of emotion recognition (RMET)

  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.

Study Arms (2)

Bipolar 1 disorder

Control subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• an autoimmune disorder or inflammatory diseases;
• currently on anti-inflammatory drugs, cortisol or cortisol derivates;
• cardiovascular impairment with life-threatening issues;
• electroconvulsive therapy in the last 12 months;
• current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen;
• IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest" version B (MWT-B);
• MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or
• other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires).
• absence of any axis I disorder according to DSM-5 and physical illness that might interfere with participant's cognitive performance;
• age between 18 and 65 years according to clinical group; and
• ability to give written informed consent for MRI and study participation.
• first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies;

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Medical School Hamburg: collaborator
• University of Innsbruck, Austria: collaborator

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Links

• FWF Austrian science fund website
• Reposity to store study results

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells (PBMC), plasma

MeSH Terms

Conditions

Bipolar Disorder; Wounds and Injuries

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Noora Tuovinen, PhD

CONTACT

+4351250483819; noora.tuovinen@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 3, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)