Cognitive Training for Psychosis

(E-SMART Trial)

Overseen By Felicia Martins, HBSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Neurological disease, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Executive Function Training is a cognitive training approach that specifically trains executive functioning for people with schizophrenia-spectrum disorders. The current study compares full executive function training to computerized training alone and to strategy monitoring alone.

Who Is on the Research Team?

Michael Best, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65 with a clinical diagnosis of schizophrenia, schizoaffective disorder, or another psychotic disorder. Participants should not be abusing drugs or alcohol and must know how to use a computer. It's not for those with physical handicaps, recent cognitive training, neurological diseases/damage, history of significant head injury, or illnesses affecting brain function.

Inclusion Criteria

Not abusing drugs or alcohol

Ability to use a computer

I have been diagnosed with schizophrenia or a similar psychotic disorder.

Exclusion Criteria

Enrolled in a cognitive training program in the last 6 months

I have a neurological condition or damage.

I have a medical condition that affects my brain function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 4 weeks of group treatment with two 1-hour sessions per week, delivered virtually via Zoom

4 weeks

8 virtual group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Cognitive Training
• Executive Function Training
• Strategy Development

Trial Overview The study examines the effectiveness of full executive function training compared to only computerized cognitive training and strategy monitoring in individuals with schizophrenia-spectrum disorders. The goal is to improve their executive functioning skills.

How Is the Trial Designed?

Group I: Strategy Development only Experimental Treatment 1 Intervention

In Strategy Development only participants will engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life. Between sessions, participants will be encouraged to practice their cognitive strategies in their daily life and track their strategies using the strategy worksheet. There will be no computerized cognitive training in this condition. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

Group II: Computerized Cognitive Training only Experimental Treatment 1 Intervention

In Computerized Cognitive Training only participants will spend the entire one-hour session practicing computerized training exercises. Between sessions participants will be encouraged to practice the computerized exercises at home for 40 minutes per day. There will be no strategy development in this condition. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

Group III: Executive Training Active Control 2 Interventions

The Executive Training (ET) condition will consist of the ET intervention that Dr. Best previously developed and evaluated. ET sessions consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises. Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, at home between sessions. All interventions will be delivered virtually in the participant's home and group sessions will be conducted using the online platform Zoom.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+