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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Cognitive Impairment; Social Competence
• Intervention / Treatment: Other: This is not an intervention study

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Individuals with a diagnosis of schizophrenia will be compared to healthy control participants

Description

Inclusion Criteria:

• schizophrenia
• schizoaffective disorder

Exclusion Criteria

• diabetes
• Hyperthyroidism
• severe head trauma
• neurological disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HC; Healthy control participants	Other: This is not an intervention study; This is not an intervention study
SZ; Individuals with a diagnosis of schizophrenia	Other: This is not an intervention study; This is not an intervention study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiology: EEG	EEG mu suppression paradigm using point-light displays	1 day (when assessed)
Neurophysiology: ERP	ERP mentalizing paradigm (perspective taking)	1 day (when assessed)
Cognition	Matrics Consensus Cognitive Battery	1 day (when assessed)
Negative symptoms: clinician-rated	Positive and Negative Syndrome Scale (PANSS) 2. Objectively assessed using computerized software (FaceReader, PRAAT) of video-taped personal narratives produced by the participants	1 day (when assessed)
Negative symptoms: objective 1	FaceReader	1 day (when assessed)
Negative symptoms: objective 2	PRAAT	1 day (when assessed)
Social cognition: complex ToM	Movie for the Assessment of Social Cognition	1 day (when assessed)
Social cognition: low level ToM	The Hinting Task	1 day (when assessed)
Social cognition: facial emotion perception	Pictures of Facial Affect	1 day (when assessed)
Social cognition: body language reading	Emotion in Biological Motion test	1 day (when assessed)
Functioning	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.	1 day (when assessed)
Real-world behaviour	Day Reconstruction Method	1 day (when assessed)
Real-world social interactions	Video-ethnography	1 day (when assessed)

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 19, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: ecoval

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No