Socio-cognitive and Biological Responses to Maltreatment

Medical University Innsbruck

Status: Begins enrollment this month

Conditions: Bipolar 1 Disorder; Control Subjects

Study type: Observational

Funder types: Other

Identifiers

NCT07101107

10.55776/KLP7245424 (Other Grant/Funding Number)

1410/2020

Details and patient eligibility

About

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.

Full description

Although the contribution of childhood maltreatment (CM) to psychological (e.g. social cognition) and biological (e.g. neural, biomolecular) outcomes has been extensively studied, e.g. in schizophrenia and autism, its contribution to bipolar disorder (BD) and the role of different CM subtypes, multiplicity and timing remains unclear. The aim of the project is to investigate how a history of emotional CM is associated with multidimensional aspects of social cognitive, neural and biomolecular parameters.

The research questions addressed in this project are: i) How is a history of emotional CM associated with social cognition in control participants (CP) with no known psychiatric illness and in individuals diagnosed with BD? ii) How is a history of emotional CM related to biomolecular and neural parameters in CP and individuals diagnosed with BD? iii) How are biomolecular markers, neural parameters, and social cognitive skills related in individuals with a history of emotional CM? The primary aim of this study is to investigate the association of self-reported history of emotional CM with social cognition (i.e. emotion recognition, cognitive and affective empathy) in CP and in individuals diagnosed with BD, both with and without a history of CM. Additional aims are to characterize the association of history of emotional CM with neural (i.e. task-based and resting-state functional magnetic resonance imaging (rs-fMRI), morphometry, white matter) MRI parameters and biomolecular markers (i.e. telomere length, mitochondrial bioenergetics and biogenesis) in peripheral blood mononuclear cells and blood plasma (selected immune-response mediators).

Recruitment, clinical assessments (e.g. Maltreatment and Abuse Chronology of Exposure scale) and blood sampling of 80 CP and 80 individuals diagnosed with BD with and without a history of CM will be performed at two timepoints at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, Medical University of Innsbruck (MUI). Longitudinal MRI acquisitions will be performed at the Neuroimaging Core Facility (MUI). Clinical, MRI and biomolecular analyses will be applied, and correlations of these findings with emotional CM, multiplicity and timing will be evaluated.

The contribution of a history of emotional CM to psychological and biological outcomes in BD is unknown. This study will clarify the association between emotional CM and social cognition in BD and CP. It will study how emotional CM alters brain function and structure in regions related to social cognition. A translational approach combining MR neuroimaging with psychoneuroimmunological methods will assess neural parameters together with biomolecular markers from whole blood in relation to emotional CM and social cognition.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for individuals diagnosed with bipolar disorder (BD):

• 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.

Exclusion Criteria for individuals diagnosed with BD:

• 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;
• 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).

Inclusion Criteria for healthy volunteers:

• 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.

Exclusion Criteria for healthy volunteers:

• first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies;
• a history of any axis I disorder, neurological, developmental disorders, CNS trauma, or comorbid BPD.
• physical illness that might interfere with the participants' cognitive performance;
• an autoimmune disorder or inflammatory diseases;
• currently on anti-inflammatory drugs, cortisol or cortisol-derivates;
• cardiovascular impairments with life-threatening issues;
• current substance abuse;
• IQ≤70;
• MRI contraindications; or
• other ethical considerations.

Trial design

160 participants in 2 patient groups

Bipolar 1 disorder

Control subjects