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Completed

NCT Number: NCT04681807

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

About this study

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 a control training program on iPad that includes commercial games and control emotional attention bias training.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between (or equal to) 15-35 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

  • No diagnosis of psychosis related 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)

Treatment and study plan

Emotion Recognition Training

Behavioral

Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of an emotion recognition training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .

Control Training

Behavioral

Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of a control training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .

Primary outcomes

  1. Change in emotion recognition performance from baseline - PENN Emotion Recognition Test

    Time frame: baseline and post treatment (1 month)

    Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions

  2. Change in brain activity during emotion recognition tasks from baseline

    Time frame: baseline and post treatment (1 month)

    Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).

Sponsors and collaborators

Lead sponsor

The Royal Ottawa Mental Health Centre

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2020
Registry last updated
Jan 2, 2026

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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