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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different types of cognitive training can help individuals with schizophrenia-spectrum disorders improve executive functioning, including skills like planning, problem-solving, and task management. Participants will be divided into three groups: one combining computer exercises with strategy development, one focusing solely on strategy development, and another on computer exercises only (referred to as Computerized Cognitive Training). The online format allows easy participation from home. Suitable candidates have a clinical diagnosis of a schizophrenia-related disorder, know how to use a computer, and are not struggling with substance abuse. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance cognitive therapies for schizophrenia-spectrum disorders.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Executive Function Training is generally well-received by individuals with schizophrenia-related disorders. Previous studies have demonstrated that this training improves everyday skills like decision-making and problem-solving. No reports of serious side effects make it a safe choice for many.

For the Strategy Development approach, earlier research suggests that discussing new ways of thinking is both safe and effective. Participants usually find these discussions helpful and safe.

Several studies have tested Computerized Cognitive Training. It has improved skills like memory and attention in people with schizophrenia. This training is typically safe, with no major side effects reported. Studies indicate that participants can complete this training at home, offering a flexible option.

Overall, past studies have proven each of these training methods safe. They aim to improve thinking skills and have not been linked to serious risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cognitive training techniques for psychosis because they offer a fresh approach compared to traditional medication-based treatments. Unlike typical antipsychotics, which mainly target neurotransmitters, these methods focus on enhancing cognitive functions directly. The Executive Function Training combines computerized exercises and strategy development, providing a dual approach to boost mental skills. The Strategy Development method emphasizes practical cognitive strategies for everyday use, while the Computerized Cognitive Training focuses solely on enhancing cognitive performance through digital exercises. All of these interventions are delivered virtually, making them accessible and convenient for participants.

What evidence suggests that this trial's treatments could be effective for schizophrenia-spectrum disorders?

Research shows that Executive Function Training, one of the treatments in this trial, can improve thinking skills in people with psychosis. Studies have found that training focused on working memory can normalize cognitive patterns, potentially helping people with schizophrenia manage daily tasks better.

For the Strategy Development approach, another treatment arm in this trial, specific data is limited. However, creating cognitive strategies has been linked to better symptom control in psychotic disorders.

Computerized Cognitive Training, also studied in this trial, is well-supported. Research reviews show it significantly enhances thinking skills and daily functioning in people with schizophrenia. It also improves mental health and cognitive abilities through structured programs. Overall, each type of training in this trial offers promising ways to boost cognitive functioning in schizophrenia-related conditions. ^{6 7 8 9 10}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7409521/

Computerized Cognitive Training is Associated with ... This study aimed to determine whether TCT negatively impacts engagement in other psychosocial treatments. Patients with schizophrenia were recruited from a ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125004342

Effect of Computerized Cognitive Remediation Therapy ... Meta-analyses have shown that cognitive remediation interventions can substantially improve cognitive performance and functional outcomes ( ...

3. gpsych.bmj.com gpsych.bmj.com/content/38/2/e101969

Acceptability and impact of computerised cognitive training ... This study aimed to evaluate the effects of a 30-session CCT programme on mental well-being and cognitive performance in individuals with schizophrenia.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1477285/full

Enhanced computerized cognitive remediation therapy ... Conclusion: The effectiveness of CCRT in alleviating negative symptoms was associated with improvements in list recall, and GDNF may play a role ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4361823/

The Effectiveness of Computerized Cognitive ... Computer-assisted cognitive remediation training program was effective in improving the performance of schizophrenic patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02404194

Targeted Cognitive Training in Clinical High Risk (CHR) for ... This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7409526/

Targeted Cognitive Training Improves Auditory and Verbal ... Computerized targeted cognitive training (TCT) of auditory processing has been shown to improve verbal learning in several clinical trials of schizophrenia ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1363290/full

Effect of computerized cognitive remediation therapy on ... CCRT can improve the MTT ability of SCZ patients, which is manifested by an increase in the concretiveness of recalling past and imagining future events.

9. cotipplab.umn.edu cotipplab.umn.edu/cognitive-training-delivered-remotely-individuals-psychosis-roam

Cognitive Training Delivered Remotely to Individuals with ... The purpose of this study is to use remote methods and scalable interactive neurotechnology to generate important data on the potential for remote targeted ...

10. jmir.org jmir.org/2023/1/e48634/

The Effects of Remote Cognitive Training Combined With a ... Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, ...