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

Schizophrenia Clinical Trial

— ecoval  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03543553
• Other study ID #: ecoval
• Status: Not yet recruiting
• Start date: January 1, 2025
• Est. completion date: March 31, 2027

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 55 Years

Eligibility

Inclusion Criteria:

• schizophrenia

• schizoaffective disorder

Exclusion Criteria

• diabetes

• Hyperthyroidism

• severe head trauma

• neurological disease

Related Conditions & MeSH terms

• Cognitive Impairment
• Schizophrenia
• Social Competence

Intervention

Other:
• This is not an intervention study
This is not an intervention study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurophysiology: EEG	EEG mu suppression paradigm using point-light displays	1 day (when assessed)
Primary	Neurophysiology: ERP	ERP mentalizing paradigm (perspective taking)	1 day (when assessed)
Primary	Cognition	Matrics Consensus Cognitive Battery	1 day (when assessed)
Primary	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)
Primary	Negative symptoms: objective 1	FaceReader	1 day (when assessed)
Primary	Negative symptoms: objective 2	PRAAT	1 day (when assessed)
Primary	Social cognition: complex ToM	Movie for the Assessment of Social Cognition	1 day (when assessed)
Primary	Social cognition: low level ToM	The Hinting Task	1 day (when assessed)
Primary	Social cognition: facial emotion perception	Pictures of Facial Affect	1 day (when assessed)
Primary	Social cognition: body language reading	Emotion in Biological Motion test	1 day (when assessed)
Primary	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)
Primary	Real-world behaviour	Day Reconstruction Method	1 day (when assessed)
Primary	Real-world social interactions	Video-ethnography	1 day (when assessed)