Executive Function and CBT Skills Training for Schizophrenia

(E-CBSST Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST) for individuals with schizophrenia or schizoaffective disorder. The goal is to determine if this combined method improves social skills and overall daily functioning. Participants must be 60 years or older, have a diagnosis of schizophrenia or schizoaffective disorder, and be clinically stable (no recent hospital admissions or medication changes).

As an unphased study, this trial provides a unique opportunity to explore innovative treatments that could enhance daily life.

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 prior data suggests that this intervention is safe?

Research shows that Cognitive-Behavioral Social Skills Training (CBSST) is generally well-tolerated by people with schizophrenia. Studies indicate that CBSST can help prevent social difficulties and improve daily functioning over time. These studies have reported no major safety concerns, suggesting that the treatment is safe for participants. The new approach, E-CBSST, combines CBSST with Executive Function Training and builds on these positive findings. While this combination is still being tested, its components showed promise in earlier trials. Always consult a healthcare professional to learn more about the safety of this treatment in a clinical trial setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for schizophrenia, which often focus on medication and traditional therapy to manage symptoms, E-CBSST (Executive Function and CBT Skills Training) takes a unique approach by enhancing cognitive and behavioral skills. Researchers are excited about E-CBSST because it targets the executive functions—critical mental skills used in planning, problem-solving, and attention. By focusing on these specific cognitive areas, E-CBSST aims to empower individuals with schizophrenia to improve their daily functioning and overall quality of life. This approach could complement existing treatments and offer a more holistic way to manage the condition.

What evidence suggests that E-CBSST might be an effective treatment for schizophrenia?

Research has shown that Cognitive-Behavioral Social Skills Training (CBSST) helps people with schizophrenia maintain social skills over a year. Those with schizophrenia later in life have demonstrated significant improvement with this method. This trial tests a new treatment, E-CBSST, which adds Executive Function Training to CBSST. It aims to further enhance these skills and improve daily life. Early results suggest that E-CBSST could effectively improve social and thinking skills in schizophrenia. ^{1 2 3 6 7}

Who Is on the Research Team?

Tarek Rajji, MD

Principal Investigator

Centre for Addiction and Mental Health

Eric Granholm, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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

Voluntary informed consent to participate

DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on SCID or MINI

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34896870/

Cognitive-Behavioral Social Skills Training for patients with ... CBSST was efficacious in patients with late-life schizophrenia and prevented decline in social function over a one-year period. CBSST was most ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996421004849

Cognitive-Behavioral Social Skills Training for patients with ... R.A. Gould et al. Cognitive therapy for psychosis in schizophrenia: an effect size analysis. Schizophr. Res. (2001).

3. withpower.com withpower.com/trial/executive-function-and-cbt-skills-training-for-schizophrenia-0d2fc

Executive Function and CBT Skills Training for Schizophrenia This trial is for individuals with schizophrenia, psychosis, or schizoaffective disorder. Participants should be interested in a new therapy that combines ...

4. utsouthwestern.elsevierpure.com utsouthwestern.elsevierpure.com/en/publications/cognitive-behavioral-social-skills-training-for-patients-with-lat

Cognitive-Behavioral Social Skills Training for patients with ... CBSST was efficacious in patients with late-life schizophrenia and prevented decline in social function over a one-year period. CBSST was most beneficial for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979120300068

Mobile-assisted cognitive-behavioral social skills training ... The results replicated multiple prior clinical trials showing improvement in functioning in schizophrenia in CBSST, but the effect of MA-CBSST on ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00832845

Cognitive Behavioral Social Skills Training for Patients ... Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. Schizophr Res ...

7. researchsquare.com researchsquare.com/article/rs-5377914/v1.pdf?c=1743606289000

Effect of Cognitive Behavioral Social Skills Training on ... Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: improvement in functioning and experiential negative.