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

Sponsor

The Royal Ottawa Mental Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04681807

Collaborator

(none)

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Emotion Recognition Training Behavioral: Active Control Training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized to either 7 visits over a period of 1 month of an emotion recognition training condition or 7 visits over a period of one month of active control training condition.Patients will be randomized to either 7 visits over a period of 1 month of an emotion recognition training condition or 7 visits over a period of one month of active control training condition.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Due to the nature of the intervention, treatment administrators will not be able to remain blind to group assignment; however, assessment staff, investigators, and participants will be blind to group assignment. Assessment staff and investigators will never be involved in the randomization or treatment procedures.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emotion Recognition Training	Behavioral: Emotion Recognition Training 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) .
Active Comparator: Active Control Training	Behavioral: Active Control Training 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) .

Arm

Intervention/Treatment

Experimental: Emotion Recognition Training

Behavioral: Emotion Recognition Training

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) .

Active Comparator: Active Control Training

Behavioral: Active Control Training

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) .

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Royal Ottawa Mental Health Centre	Ottawa	Ontario	Canada	K1Z 7K4

Sponsors and Collaborators

The Royal Ottawa Mental Health Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Synthia Guimond, Principal Investigator, The Royal Ottawa Mental Health Centre

ClinicalTrials.gov Identifier:

NCT04681807

Other Study ID Numbers:

2019033

First Posted:

Dec 23, 2020

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Apr 28, 2022