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Socio-cognitive and Biological Responses to Maltreatment

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Jul 1, 2026 to Jul 20, 2026
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised
  2. Notable Start date: May 1, 2026 to Jul 1, 2026
    • Secondary endpoints: 7 to 8
    v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Start date: Mar 1, 2026 to May 1, 2026v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07101107
Lead Sponsor Medical University Innsbruck
Collaborators: Medical School Hamburg, University of Innsbruck, Austria
Conditions
(from sponsor)
Bipolar 1 Disorder, Control Subjects
Related terms Bipolar Disorder, Wounds and Injuries
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov