Executive Function and CBT Skills Training for Schizophrenia

(E-CBSST Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Tarek Rajji, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

Must be taking: Antipsychotics

Disqualifiers: Cognitive disorder, Bipolar, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training (CBSST) Skills Learning to a level that will lead to a clinically meaningful improvement in functioning.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your antipsychotic medication dosage has not changed in the four weeks before starting the study.

What data supports the effectiveness of the treatment E-CBSST for schizophrenia?

Research shows that Cognitive Behavioral Social Skills Training (CBSST), a component of E-CBSST, improves functioning in people with schizophrenia compared to standard care alone. Additionally, CBSST has been found to enhance social function, especially in patients with more severe executive dysfunction, indicating its potential benefit in improving life skills for those with schizophrenia. ^{1 2 3 4 5}

Is Executive Function and CBT Skills Training for Schizophrenia safe for humans?

The studies on Cognitive Behavioral Social Skills Training (CBSST) and its variations, like CBSST-CCT, suggest that these interventions are generally safe for people with schizophrenia. Participants in these studies did not report significant safety concerns, and the interventions were deemed acceptable, with no modifications needed to the procedures. ^{1 2 3 6 7}

How is the E-CBSST treatment different from other treatments for schizophrenia?

E-CBSST is unique because it combines executive function training with Cognitive-Behavioral Social Skills Training (CBSST), specifically targeting cognitive deficits and social skills in people with schizophrenia. This approach is designed to improve both cognitive abilities and social functioning, which are often impaired in schizophrenia, making it different from standard treatments that may not address these areas as comprehensively. ^{1 2 3 4 8}

Research Team

Tarek Rajji, MD

Principal Investigator

Centre for Addiction and Mental Health

Eric Granholm, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for individuals with schizophrenia, psychosis, or schizoaffective disorder. Participants should be interested in a new therapy that combines cognitive and behavioral skills training with exercises to improve thinking and decision-making.

Inclusion Criteria

Clinically stable as operationalized by not having been admitted to a psychiatric hospital within the three months prior to assessment, having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and ascertained to be clinically and medically stable by one of the study investigators

Able to read and converse (with corrected vision or hearing if needed)

Voluntary informed consent to participate

Exclusion Criteria

I have a condition that affects my ability to participate in specific brain training programs.

I have been diagnosed with bipolar disorder, depression, or substance abuse in the last 6 months.

I have not had electroconvulsive therapy in the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Executive Function Training

Participants undergo a 2-week Executive Function Training course with 3 sessions per week of computerized exercises and strategy monitoring

2 weeks

6 sessions (in-person)

E-CBSST Cycle 1

Participants complete the first cycle of E-CBSST with 18 sessions, delivered twice a week, including brief EFT at the start of CBSST group sessions

9 weeks

18 sessions (in-person)

E-CBSST Cycle 2

Participants complete the second cycle of E-CBSST with another 18 sessions, delivered twice a week, including brief EFT at the start of CBSST group sessions

9 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• E-CBSST (Behavioural Intervention)

Trial Overview The study tests E-CBSST, which blends Executive Function Training (to enhance thinking and decision-making) with Cognitive-Behavioral Skills Training (for social skills). It aims to see if this can significantly improve daily functioning.

Participant Groups

Group I: E-CBSST Experimental Treatment 1 Intervention

E-CBSST is the experimental arm in this study.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Dr. Catherine Zahn

Centre for Addiction and Mental Health

Chief Executive Officer since 2009

MD, University of Toronto

Dr. James Graham

Centre for Addiction and Mental Health

Chief Medical Officer since 2024

PhD in Functional Neuroimaging

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Neuropsychological predictors of functional outcome in Cognitive Behavioral Social Skills Training for older people with schizophrenia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Executive functions rehabilitation for schizophrenia: a critical systematic review. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of the Occupational Goal Intervention method for the improvement of executive functioning in patients with treatment-resistant schizophrenia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Reducing negative symptoms in schizophrenia: Feasibility and acceptability of a combined cognitive-behavioral social skills training and compensatory cognitive training intervention. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Which executive skills should we target to affect social functioning and symptom change? A study of a cognitive remediation therapy program. [2019]