Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorMedical University Innsbruck
About this trial
This study aims to better understand how schizophrenia may affect social thinking, emotion regulation, brain function, and biological processes over time.
Two groups will take part in the study:
1. people diagnosed with schizophrenia 2. healthy adults without schizophrenia
Participants in both groups will complete a series of behavioral tasks and questionnaires. These will assess abilities such as understanding other people, processing social information, and regulating emotions. For participants with schizophrenia, we will also assess clinical symptoms and their severity.
The study includes three assessment visits:
1. Baseline: at the beginning of the study 2. 12-month follow-up: approximately one year later 3. 24-month follow-up: approximately two years later
At all three visits, participants will complete behavioral tests and questionnaires, and blood and hair samples will be collected. These samples may help researchers investigate biological factors that are related to mental health, stress, and changes over time.
Participants will also undergo an MRI brain scan at the baseline visit and again at the 12-month follow-up.
People with schizophrenia may experience changes in thinking, emotions, social functioning, physical health, and brain function across adulthood. However, we still do not fully understand how these changes develop over time or how they differ from normal aging.
By comparing people with schizophrenia with healthy adults of different ages and following them over time, we can study possible differences in aging trajectories. This means examining whether certain abilities, symptoms, biological markers, or brain characteristics change differently with age in people with schizophrenia.
The study uses an accelerated longitudinal design. Instead of following one group of people for many decades, researchers recruit participants from different age groups and follow them for a shorter period. Combining information across these age groups can help researchers estimate longer-term patterns of change.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Participants with SZ will be recruited through multiple clinical pathways to ensure adequate sample size and representativeness across the adult lifespan. The primary recruitment source is the specialized outpatient clinic for SZ spectrum disorders at the Department of Psychiatry, MUI, which serves a large catchment area and maintains detailed diagnostic records. Additional participants will be recruited through a collaborating psychiatric hospital and office-based psychiatrists and psychosocial service providers in the region, with whom the Dep. of Psychiatry maintains established referral networks. Patients in the SZ group must have a DSM-5 diagnosis of schizophrenia confirmed by their treating psychiatrist. HC participants will be recruited through advertisements in online platforms, social media, and community outreach.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
180 Participants
are grouped into 2 trial groupsGroup A: Schizophrenia Group
Group B: Healthy control group
Trial outcomes
Primary outcomes
1
Change in Theory of Mind performance
Theory of Mind will be assessed using the EmpaToM task. The outcome will include performance-based indices of cognitive and affective Theory of Mind. Higher scores indicate better ability to infer and understand the mental states of others.
Time frame
Baseline, 12 months, and 24 months2
Change in attributional style
Attributional style will be assessed using the Internal, Personal and Situational Attributions Questionnaire-Revised. The outcome will measure tendencies to attribute positive and negative social events to internal, personal-external, or situational-external causes; aswell as monocausal-inference-style.
Time frame
Baseline, 12 months, and 24 months3
Change in emotion recognition performance
Emotion recognition will be assessed using the DiagnosIS Emotion Recognition Task. The outcome will measure accuracy in identifying facial emotional expressions. Higher scores indicate better emotion recognition performance.
Time frame
Baseline, 12 months, and 24 months4
Change in Emotion Regulation Choice
The Emotion Regulation Choice Task is a behavioral paradigm used to examines whether individuals adapt their choice of emotion regulation strategy according to the intensity of negative emotional stimuli. It will be used to assess the change in the degree to which strategy choice changes as a function of emotional intensity.
Time frame
Baseline, 12 months, 24 monthsSecondary outcomes
1
Change in reflective functioning
Reflective functioning will be assessed using the Reflective Functioning Questionnaire. The outcome will measure certainty and uncertainty about mental states. Scores will be analyzed according to the scoring rules of the instrument.
Time frame
Baseline, 12 months, and 24 months2
Change in self reported Emotion Regulation
Self reported emotion regulation will be assessed using the Emotion Regulation Questionnaire (ERQ). The ERQ is a 10-item self-report measure assessing the habitual use of two emotion-regulation strategies: cognitive reappraisal and expressive suppression.
Time frame
Baseline, 12 months, 24 months3
Change in global cognitive functioning
Global cognition will be assessed using the Screen for Cognitive Impairment in Psychiatry. The outcome will provide a standardized measure of cognitive functioning across domains including verbal learning, working memory, verbal fluency, and processing speed. Higher scores indicate better cognitive performance.
Time frame
Baseline, 12 months, and 24 months4
Change in daily functioning and disability
Daily functioning and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0. The outcome will measure functioning across cognition, mobility, self-care, interpersonal relationships, life activities, and participation in society. Higher scores indicate greater disability.
Time frame
Baseline, 12 months, and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University Innsbruck
Lead sponsor
Technische Universität Dresden
Collaborator
University of Innsbruck, Austria
Collaborator
Source ClinicalTrials.gov