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

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ClinicalTrials.gov Identifier: NCT03543553
Recruitment Status : Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Anja Vaskinn, Oslo University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Schizophrenia Cognitive Impairment Social Competence Other: This is not an intervention study

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Group/Cohort Intervention/treatment
SZ
Individuals with a diagnosis of schizophrenia
 Other: This is not an intervention study
This is not an intervention study
HC
Healthy control participants
 Other: This is not an intervention study
This is not an intervention study


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals with a diagnosis of schizophrenia will be compared to healthy control participants
Criteria

Inclusion Criteria:

  • schizophrenia
  • schizoaffective disorder

Exclusion Criteria

  • diabetes
  • Hyperthyroidism
  • severe head trauma
  • neurological disease
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Anja Vaskinn, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03543553    
Other Study ID Numbers: ecoval
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders