Examining Strategy Monitoring and Remediation Training (E-SMART)

University of Toronto

Status: Completed

Conditions: Psychotic Disorders; Executive Dysfunction

Treatments: Other: Computerized Cognitive Training; Other: Strategy Development

Study type: Interventional

Funder types: Other

Identifiers

NCT04756388

39698

Details and patient eligibility

About

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.

Full description

All interventions will involve 4 weeks of group treatment consisting of two 1-hour group sessions per week and additional practice at home between sessions. The Executive Training condition will 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. 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. 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.

90 participants with schizophrenia-spectrum disorders will be recruited. Power analyses, conducted with GPower, indicate that 90 participants (30 per treatment condition), accounting for an upper limit of 25% attrition observed in my previous trials of ET, provides 80% power to detect a medium effect size (cohen's f = 0.2) difference between conditions.

Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation. The primary endpoint is the 3-month follow-up assessment, and secondary endpoint of post-treatment will also be examined.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of schizophrenia, schizoaffective disorder or any other psychotic disorder (based on DSM-V)
• 18-65 years of age
• know how to use a computer
• not abusing drugs or alcohol
• can read and speak English.

Exclusion criteria

• enrolled in a cognitive training program in the last 6 months
• neurological disease or neurological damage
• medical illnesses that can change neurocognitive function
• medical history of head injury with loss of consciousness
• physical handicaps

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Executive Training

Active Comparator group

Description:

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.

Treatment:

Other: Strategy Development

Other: Computerized Cognitive Training

Strategy Development only

Experimental group

Description:

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.

Treatment:

Other: Strategy Development

Computerized Cognitive Training only

Experimental group

Description:

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.

Treatment:

Other: Computerized Cognitive Training