SchizophreniaE-CBSSTNCT06251193
Optimizing CBSST With Executive Function Training for Schizophrenia
A study testing E-CBSST in people with Schizophrenia and Schizoaffective Disorder, run by University of California, San Diego at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- E-CBSST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Mar 2024to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia
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.
Read the detailed description
Older adults with schizophrenia are at risk for cognitive and functional decline leading to premature institutionalization. A large and increasing number of older people with schizophrenia will need more effective services. The investigators previously developed Cognitive Behavioral Social Skills Training (CBSST) and established its efficacy for preventing functional decline in people with schizophrenia. CBSST combines Cognitive Behavioral Therapy (CBT), Social Skills Training (SST), and problem-solving intervention modules in an 18-session intervention that is repeated to practice the skills for a total of 36 sessions. The findings suggested that CBSST Skills Learning is an important mechanism of change in functioning in CBSST and that boosting executive function could boost CBSST Skills Learning, which could improve rather than only stabilize functioning. The investigators intend to test a blended intervention that combines CBSST and Executive Functioning Training (E-CBSST). In this open trial, 50 participants with schizophrenia or schizoaffective disorder age 60 or older will be enrolled to receive E-CBSST for 20 weeks. E-CBSST will consist first of a 2-week Executive Function Training (EFT) course that includes 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist. Participants will then complete 2 cycles of E-CBSST with 18 sessions each cycle, delivered twice a week, during which participants receive brief EFT at the start of CBSST group sessions. Outcome assessments will be administered at baseline, end of Executive Function Training course (Week 2), after session 18 (mid-trial; end of first cycle) and session 36 (end-trial; end of second cycle).
The aims of the study include determining if E-CBSST is feasible and increases CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning and to identify the minimum number of weeks of the intervention needed to produce this change. E-CBSST could become an evidence-based intervention that enhances and not only maintains function and, in turn, reduces personal and societal burden.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- E-CBSST
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CBSSTBehavioural
E-CBSST is a blended intervention that combines Cognitive Behavioral Social Skills Training and Executive Function Training.
| Study group | Role | What they receive |
|---|---|---|
| E-CBSST | Experimental | E-CBSST is the experimental arm in this study. Receives: Behavioral: E-CBSST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Secondary outcomes (10)
Social Skills Performance Assessment
The Social Skills Performance Assessment (SSPA) is a role-play measure of social skill and ability to resolve interpersonal problems through conversation. The SSPA consists of role-play communication scenarios (conversation initiation and assertion), during which the participant interacts with a live confederate who plays a role (e.g., boss) in a problem-oriented situation (e.g., asking for a work shift change). Scores range from 2-10 with higher scores indicating better social skills.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Brief Assessment of Cognition in Schizophrenia
The BACS is a neuropsychological battery designed for use in schizophrenia clinical trials. The BACS assesses domains of neuropsychological impairment frequently observed in individuals with schizophrenia, including: verbal memory, working memory, motor speed, attention, executive functions and verbal fluency. Higher scores indicate better performance.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Delis-Kaplan Executive Function System
The Delis-Kaplan Executive Function System (D-KEFS) is a standardized set of tests to evaluate higher level cognitive functions. The Color-Word Interference subtest will be administered. Higher scores on this measure are indicative of greater executive functioning skills.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Executive Interview
The Executive Interview (EXIT) is a bedside assessment of executive function scored from 0-50. Higher scores indicate greater executive dyscontrol.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale (PANSS) is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Scores range between 0 and 30 points. Higher scores indicate more severe depressive symptoms.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Cumulative Illness Rating Scale-Geriatric
The Cumulative Illness Rating Scale-Geriatric (CIRS-G) is a comprehensive measure to assess for physical impairment in older adults. The measure takes into consideration the severity of chronic diseases in 14 items representing individual body systems. The cumulative final score ranges from 0 to 56 with higher scores indicating higher severity.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Defeatest Performance Attitudes Scale
The Defeatist Performance Attitude Scale (DPAS) is a self-report subscale derived from factor analysis of the commonly-used Dysfunctional Attitude Scale, which measures the tendency to overgeneralize from past failure experiences and form defeatist beliefs about the ability to perform future goal-directed tasks. Items are rated on a 1-7 Likert scale. A total score is reported with a range of 7 - 105 with higher total scores indicating more severe defeatist performance attitudes.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Clinical Assessment Interview for Negative Symptoms
The Clinical Assessment Interview for Negative Symptoms (CAINS) is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Birchwood Social Functioning Scale
The Birchwood Social Functioning Scale (SFS) is a self-report assessment of functioning with 7 subscales, and each item is rated from 0 to 3. The Prosocial Activities (0-66) subtest will be administered. Higher scores indicate better functioning.
Measured: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start20 Mar 2024
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Eric Granholm, University of California, San Diego
- Investigators
- Eric Granholm, PhD, Principal investigator, University of California, San DiegoTarek Rajji, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251193
- Sponsor's protocol ID
- R61MH132859
- Acronym
- E-CBSST
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per terms of the award, participant-level data will be uploaded to the NIMH Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT06251193
- Acronym / sponsor ID
- E-CBSST / R61MH132859
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Older adults with schizophrenia are at risk for cognitive and functional decline leading to premature institutionalization. A large and increasing number of older people with schizophrenia will need more effective services. The investigators previously developed Cognitive Behavioral Social Skills Training (CBSST) and established its efficacy for preventing functional decline in people with schizophrenia. CBSST combines Cognitive Behavioral Therapy (CBT), Social Skills Training (SST), and problem-solving intervention modules in an 18-session intervention that is repeated to practice the skills for a total of 36 sessions. The findings suggested that CBSST Skills Learning is an important mechanism of change in functioning in CBSST and that boosting executive function could boost CBSST Skills Learning, which could improve rather than only stabilize functioning. The investigators intend to test a blended intervention that combines CBSST and Executive Functioning Training (E-CBSST). In this open trial, 50 participants with schizophrenia or schizoaffective disorder age 60 or older will be enrolled to receive E-CBSST for 20 weeks. E-CBSST will consist first of a 2-week Executive Function Training (EFT) course that includes 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist. Participants will then complete 2 cycles of E-CBSST with 18 sessions each cycle, delivered twice a week, during which participants receive brief EFT at the start of CBSST group sessions. Outcome assessments will be administered at baseline, end of Executive Function Training course (Week 2), after session 18 (mid-trial; end of first cycle) and session 36 (end-trial; end of second cycle).
The aims of the study include determining if E-CBSST is feasible and increases CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning and to identify the minimum number of weeks of the intervention needed to produce this change. E-CBSST could become an evidence-based intervention that enhances and not only maintains function and, in turn, reduces personal and societal burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-CBSST | Experimental | Behavioral: E-CBSSTE-CBSST is the experimental arm in this study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CBSSTE-CBSST is a blended intervention that combines Cognitive Behavioral Social Skills Training and Executive Function Training. | Behavioural | E-CBSST |
Primary outcome
Independent Living Skills Survey
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
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.
Comprehensive Modules Test
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
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.
10 secondary outcomes
Social Skills Performance Assessment
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Brief Assessment of Cognition in Schizophrenia
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Delis-Kaplan Executive Function System
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Executive Interview
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Positive and Negative Syndrome Scale
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Geriatric Depression Scale
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Cumulative Illness Rating Scale-Geriatric
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Defeatest Performance Attitudes Scale
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Clinical Assessment Interview for Negative Symptoms
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Birchwood Social Functioning Scale
Time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Yes. Per terms of the award, participant-level data will be uploaded to the NIMH Data Archive (NDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Granholm, PhD principal investigator
University of California, San Diego
Tarek Rajji, MD principal investigator
Centre for Addiction and Mental Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-CBSST in people with Schizophrenia and Schizoaffective Disorder, run by University of California, San Diego at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent Living Skills Survey (time frame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025; AzTrials last refreshed its copy on 2 Nov 2026.