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NCT Number: NCT03543553

From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia

The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. Much research within the field is devoid of personal meaning and interpersonal context. This project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.

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Key information

Conditions

Schizophrenia Behavior Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders Social Behavior Social Competence Social Skills

Age range

17 year–55 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • schizophrenia
  • schizoaffective disorder

Exclusion criteria

  • diabetes
  • Hyperthyroidism
  • severe head trauma
  • neurological disease

Treatment and study plan

This is not an intervention study

Other

This is not an intervention study

Primary outcomes

  1. Neurophysiology: EEG

    Time frame: 1 day (when assessed)

    EEG mu suppression paradigm using point-light displays

  2. Neurophysiology: ERP

    Time frame: 1 day (when assessed)

    ERP mentalizing paradigm (perspective taking)

  3. Cognition

    Time frame: 1 day (when assessed)

    Matrics Consensus Cognitive Battery

  4. Negative symptoms: clinician-rated

    Time frame: 1 day (when assessed)

    Positive and Negative Syndrome Scale (PANSS) 2. Objectively assessed using computerized software (FaceReader, PRAAT) of video-taped personal narratives produced by the participants

  5. Negative symptoms: objective 1

    Time frame: 1 day (when assessed)

    FaceReader

  6. Negative symptoms: objective 2

    Time frame: 1 day (when assessed)

    PRAAT

  7. Social cognition: complex ToM

    Time frame: 1 day (when assessed)

    Movie for the Assessment of Social Cognition

  8. Social cognition: low level ToM

    Time frame: 1 day (when assessed)

    The Hinting Task

  9. Social cognition: facial emotion perception

    Time frame: 1 day (when assessed)

    Pictures of Facial Affect

  10. Social cognition: body language reading

    Time frame: 1 day (when assessed)

    Emotion in Biological Motion test

  11. Functioning

    Time frame: 1 day (when assessed)

    Social Functioning Scale (SFS). Seven scales that can be combined into a total score. Mean score in a schizophrenia population = 100, SD = 15. For both the seven scales and the total score.

  12. Real-world behaviour

    Time frame: 1 day (when assessed)

    Day Reconstruction Method

  13. Real-world social interactions

    Time frame: 1 day (when assessed)

    Video-ethnography

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: ecoval

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2018
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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