Optimizing CBSST With Executive Function Training for Schizophrenia (R33)

NCT07658391 | Not Yet Recruiting DMC

• 1 other identifier: R33MH132859
• Study Type: interventional
• Estimated enrollment: 106
• Locations: 1 country
• Sites: 2
• Estimated — date passed: Study Start
• Estimated: Primary Completion
• Estimated: Study Completion

Brief Summary

This randomized controlled clinical trial will test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). E-CBSST will be delivered to adults with late-life schizophrenia to determine if it increases Cognitive Behavioral Social Skills Training skills learning more than a supportive contact control condition and leads to improved functioning.

Conditions

Schizoaffective Disorder; Schizophrenia

Keywords

Schizophrenia; serious mental illness; randomized clinical trial; executive function training; Cognitive Behavioral Social Skills Training

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 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)

• 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 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)

Secondary Outcomes (2)

• Executive Interview

  Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)

• Positive and Negative Syndrome Scale

  Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)

Study Arms (2)

E-CBSST

EXPERIMENTAL

E-CBSST is the experimental arm in this study.

Behavioral: E-CBSST

E-SC

ACTIVE COMPARATOR

E-SC is the comparator condition in this study.

Behavioral: E-SC

Interventions

E-CBSST BEHAVIORAL

E-CBSST is a blended, in-person intervention that combines components of Executive Function Training (EFT) with Cognitive Behavioral Social Skills Training (CBSST). Participants complete 6 sessions of EFT and then 36 sessions of combined EFT and CBSST. CBSST techniques are based on cognitive behavioral therapy and social skills training developed for adult patients with schizophrenia. Participants set meaningful recovery goals and then learn skills to achieve their goals.

E-CBSST

E-SC BEHAVIORAL

E-SC is a goal-focused supportive contact group therapy intervention that provides the same frequency and amount of therapist and other group member contact as E-CBSST. Participants will complete the same number of EFT sessions and then continue with semi-structured supportive contact sessions of the same number and duration as participants in the E-CBSST arm. The SC intervention will have a primary focus on setting and achieving recovery goals (e.g., living, learning, and socializing).

E-SC

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
• University of Texas Southwestern Medical Center: collaborator

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

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

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Holden, PhD

CONTACT

858-246-2517; jlholden@health.ucsd.edu

Eric Granholm, PhD

CONTACT

858-534-2542; egranholm@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Last Updated: June 23, 2026

Study Start

October 1, 2026

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Record last verified: 2026-06

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

US (2)