Optimizing CBSST With Executive Function Training for Schizophrenia

NCT06251193 | Active Not Recruiting DMC

• 1 other identifier: R61MH132859
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

• Independent Living Skills Survey

  The Independent Living Skills Survey (ILSS) assesses whether specific functioning behaviors have been performed over the past month in multiple areas: Personal Hygiene, Appearance and Care of Clothing, Care of Personal Possessions (everyday household chores), Food Preparation, Health Maintenance, Money Management, Transportation, and Leisure and Community (including socialization). Each item is rated from 0 (No) to 1 (Yes). Scales are summed to yield a total score. Higher scores represent a higher level of functioning.

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

• Comprehensive Modules Test

  The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

Secondary Outcomes (10)

• Social Skills Performance Assessment

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

• Brief Assessment of Cognition in Schizophrenia

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

• Delis-Kaplan Executive Function System

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

• Executive Interview

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

• Positive and Negative Syndrome Scale

  Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)

Study Arms (1)

E-CBSST

EXPERIMENTAL

E-CBSST is the experimental arm in this study.

Behavioral: E-CBSST

Interventions

E-CBSST BEHAVIORAL

E-CBSST is a blended intervention that combines Cognitive Behavioral Social Skills Training and Executive Function Training.

E-CBSST

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary informed consent to participate;
• Age 60 years or older;
• DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;
• Be clinically stable as operationalized by (1) not having been admitted to a psychiatric hospital within the three months prior to assessment, (2) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (3) and ascertained to be clinically and medically stable by one the study investigators;
• Be willing and able to speak English;
• Be able to read and converse (with corrected vision or hearing if needed).

You may not qualify if:

• Meets criteria for a cognitive disorder or for a neurological or other medical disorder affecting the ability to participate in Executive Function Training or CBSST;
• Meets diagnostic criteria for bipolar disorder, current major depressive episode, or substance abuse or dependence within the six months prior to the baseline assessment except for caffeine or nicotine;
• Received electroconvulsive therapy within six months of the baseline assessment.

Sponsors & Collaborators

• University of California, San Diego: lead
• Centre for Addiction and Mental Health: collaborator

Study Sites (2)

UC San Diego

La Jolla, California, 92093, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric Granholm, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Tarek Rajji, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 9, 2024
• Study Start: March 20, 2024
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded according to NDA standard data submission periods. These periods are currently twice each year.
• Access Criteria: Data access is outlined in the current NDA Policy.

Locations

CA (1); US (1)