Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia

Not Applicable

Recruiting

• Conditions: Schizophrenia
• Interventions: Behavioral: Emotion Recognition Training; Behavioral: Active Control Training

• Registration Number: NCT04681807
• Lead Sponsor: The Royal Ottawa Mental Health Centre

Brief Summary

Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.

Detailed Description

All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or an active control training program on iPad that includes commercial games and control emotional attention bias training.

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-07-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Between (or equal to) 15-25 years of age
• Ability to read/speak fluent English
• Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).

Exclusion Criteria

• Diagnosis of mental health disorder
• Significant neurological or medical disorders that may produce cognitive impairment
• Current epilepsy or previous history of seizures
• Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
• Recent history of substance abuse or dependence (within past 3 months)
• MRI contraindication (e.g. metallic head implant, history of seizure, pacemaker, pregnancy, etc.)
• Current IQ < 70 as measured by the Wechsler Abbreviated Scale of Intelligence Scale (WASI)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emotion Recognition Training	Emotion Recognition Training	-
Active Control Training	Active Control Training	-

Primary Outcome Measures

Name	Time	Method
Change in emotion recognition performance from baseline - PENN Emotion Recognition Test	baseline and post treatment (1 month)	Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions
Change in brain activity during emotion recognition tasks from baseline	baseline and post treatment (1 month)	Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).

Trial Locations

Locations (1)

The Royal Ottawa Mental Health Centre; 🇨🇦 Ottawa, Ontario, Canada