Executive Function and CBT Skills Training for Schizophrenia

(E-CBSST Trial)

Recruiting at 1 trial location

Overseen By Eric Granholm, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Antipsychotics

Disqualifiers: Cognitive disorder, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 42

50 Participants Needed

Trial Summary

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}

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.

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.

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

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+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Findings from Research

Cognitive Behavioral Social Skills Training (CBSST) significantly improved functional outcomes in individuals with schizophrenia compared to standard treatment alone, regardless of the severity of their neuropsychological impairment.

The study found that improvements in neuropsychological abilities did not mediate the functional gains from CBSST, indicating that the therapy's benefits are independent of changes in cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological predictors of functional outcome in Cognitive Behavioral Social Skills Training for older people with schizophrenia. Granholm, E., McQuaid, JR., Link, PC., et al.[2021]

Cognitive rehabilitation (CR) programs show promise in improving executive functions and social adjustment in individuals with schizophrenia, based on a systematic review of 30 randomized controlled trials (RCTs).

The average intervention lasted about 80 hours, and CR was found to be particularly effective when combined with cognitive behavioral therapy or group sessions, suggesting that integrated approaches may enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive functions rehabilitation for schizophrenia: a critical systematic review. Kluwe-Schiavon, B., Sanvicente-Vieira, B., Kristensen, CH., et al.[2018]

Cognitive-Behavioral Social Skills Training (CBSST) significantly improved social functioning in older patients with schizophrenia over a one-year period, as shown by better scores on the Independent Living Skills Survey compared to those receiving Treatment-As-Usual.

Participants with more severe executive dysfunction benefited the most from CBSST, indicating that this intervention is particularly effective for those who need social skills training the most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. Rajji, TK., Mamo, DC., Holden, J., et al.[2022]

A study involving 111 participants with schizophrenia spectrum disorders found that both targeted cognitive training with social cognitive exercises (TCT + SCT) and targeted cognitive training alone (TCT) led to lasting improvements in cognition, symptoms, and functional capacity six months after the intervention.

Participants who received TCT + SCT showed greater and more enduring benefits in prosody identification and reward processing compared to those who only received TCT, suggesting that integrating social cognitive training can enhance functional outcomes in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. Miley, K., Fisher, M., Nahum, M., et al.[2022]

The Occupational Goal Intervention (OGI) method significantly improved executive functions in 25 patients with Treatment-Resistant Schizophrenia (TRS) over 30 sessions, as measured by the Behavioural Assessment of the Dysexecutive Syndrome (BADS).

Families reported noticeable improvements in various aspects of executive functions, although the OGI did not show significant effects on all secondary outcomes, except for enhanced communication skills.

NCBI (Pubmed)

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. Vizzotto, AD., Celestino, DL., Buchain, PC., et al.[2022]

The integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) significantly reduced negative symptoms in individuals with schizophrenia, particularly improving motivation, as shown in a pilot study with 55 participants over 12.5 weeks.

CBSST-CCT also enhanced verbal learning abilities compared to the Goal-focused Supportive Contact group, with these benefits lasting up to 6 months after treatment, indicating its potential for long-term impact on cognitive performance.

NCBI (Pubmed)

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. Granholm, E., Twamley, EW., Mahmood, Z., et al.[2022]

The integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention was found to be acceptable to participants, with similar attendance rates compared to the Goal-Focused Supportive Contact group, indicating potential for engagement in treatment.

Despite the intervention's acceptability, the study faced challenges with participant retention, as over one-third of participants dropped out, highlighting the need for strategies to improve retention in future trials.

NCBI (Pubmed)

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. Mahmood, Z., Van Patten, R., Keller, AV., et al.[2022]

In a study of 63 participants with schizophrenia, individual cognitive remediation therapy (CRT) led to significant improvements in verbal working memory, which was linked to social functioning and symptom severity after 3 months.

Changes in stimulus-driven responding and response inhibition speed were associated with reduced social problems and negative symptoms, suggesting these cognitive factors could be important targets for future psychological interventions.

NCBI (Pubmed)

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. Reeder, C., Newton, E., Frangou, S., et al.[2019]

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]