Cognitive Enhancement Therapy vs. Social Skills Training for Mental Illness

Recruiting at 4 trial locations

Overseen By Jennifer Sabbagh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Organic brain syndrome, Intellectual disability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

378 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST), to determine which better helps individuals with mental illness improve everyday social skills. CET boosts cognitive and social skills through computer-based and group exercises, while SST uses role-playing and practice to enhance social interactions and health. The study seeks participants aged 18 to 65 diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder who have not participated in CET or SST in the past year. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance mental health treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) are generally safe. CET has improved cognitive and social interactions successfully. Studies have not identified any major side effects, indicating it is well-tolerated.

SST is also considered safe and aids individuals with serious mental illnesses like schizophrenia. It enhances social and health-related skills through activities such as role-playing and feedback. Evidence supports its effectiveness and safety, with no major safety concerns reported.

Overall, both treatments have been applied in various settings without significant safety issues, making them reliable options for improving mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) because these approaches offer unique ways to improve mental health outcomes. Unlike traditional treatments that might focus solely on medication or basic counseling, CET uses a combination of computer-based exercises and group activities to boost both brain function and social skills, which could lead to better social interactions and quality of life. On the other hand, SST employs techniques like role-playing and real-world practice to enhance communication and social functioning, which are often challenging for those with mental illness. These therapies aim to address the cognitive and social aspects of mental health, offering a more holistic approach compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for improving community functioning in mental illness?

This trial will compare Cognitive Enhancement Therapy (CET) with Social Skills Training (SST) for individuals with mental illness. Research has shown that CET, which participants in this trial may receive, improves thinking and social skills. One study found that CET led to significant improvements in brain function and understanding social situations, surpassing other treatments. Meanwhile, SST, another treatment option in this trial, has proven to enhance social abilities in people with mental health challenges. Studies have shown that SST helps individuals perform better in social settings and improves their overall social life. Both CET and SST effectively help people with mental illness function better in their communities. ^{6 7 8 9 10}

Who Is on the Research Team?

Matcheri S Keshavan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Russell K Schutt, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 65 with a diagnosis of schizophrenia or related disorders, who have an IQ over 70. It's not suitable for those with brain syndromes, intellectual disabilities, or recent participation in the therapies being tested.

Inclusion Criteria

Estimated IQ of > 70 (established via WTAR)

I have been diagnosed with schizophrenia or a related disorder.

Exclusion Criteria

Participation in either CET or SST within the prior year.

Presence of a current organic brain syndrome

Intellectual disability (DSM-5)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Enhancement Therapy (CET) or Social Skills Training (SST) to improve community functioning

24 months

Regular visits at 0, 6, 12, 18, 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Enhancement Therapy
• Social Skills Training

Trial Overview The study compares Cognitive Enhancement Therapy (CET) and Social Skills Training (SST), both known to improve community functioning in people with serious mental illness. Mental health centers are randomly chosen to use either CET or SST.

How Is the Trial Designed?

Group I: Cognitive Enhancement Therapy Experimental Treatment 1 Intervention

CET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition.

Group II: Social Skills Training Active Control 1 Intervention

The HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health..

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Cognitive enhancement therapy (CET) significantly improved overall cognition in patients with early-course schizophrenia over an 18-month period, as confirmed by a study involving 102 outpatients.

While CET showed promising effects on social cognition and attention, it did not significantly outperform enriched supportive therapy (EST) in improving social adjustment, although the benefits appeared to increase for those who completed the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. Wojtalik, JA., Mesholam-Gately, RI., Hogarty, SS., et al.[2023]

Cognitive Enhancement Therapy (CET) aims to improve social cognition in schizophrenia patients by using interactive software and group exercises, focusing on abstract thinking and social context understanding.

Preliminary observations suggest that CET effectively addresses cognitive deficits related to social interactions, potentially helping patients manage symptoms of schizophrenia more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice principles of cognitive enhancement therapy for schizophrenia. Hogarty, GE., Flesher, S.[2019]

A randomized controlled trial with 112 participants showed that cognitive and emotional remediation training (CERT-D) significantly improved psychosocial function and reduced symptom severity in individuals with Major Depressive Disorder (MDD).

The training focused on enhancing cognitive, emotional, and social-cognitive skills through repeated exercises, suggesting that this approach could be a cost-effective alternative to traditional psychological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological training to improve psychosocial function in patients with major depressive disorder: A randomised clinical trial. Knight, MJ., Lyrtzis, E., Fourrier, C., et al.[2023]

Social skills training is an effective treatment for social dysfunction in psychiatric outpatients, showing benefits for up to 16 months after the intervention, and is more effective than other methods like short-term psychotherapy.

This training focuses on teaching new social behaviors through practice, and it is recommended as the preferred treatment for patients with social dysfunction, particularly when they do not have other major psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of social dysfunction in nonpsychotic outpatients. A review. Stravynski, A., Shahar, A.[2019]

This study compares the effectiveness of Cognitive Enhancement Therapy (CET) and Social Skills Training (HOPES/SST) in improving social and community functioning in individuals with schizophrenia, using a randomized cluster design over 12 months with groups of 6-8 clients.

The researchers hypothesize that CET will lead to greater improvements in community functioning and cognitive skills compared to SST, particularly benefiting younger individuals and those with more cognitive impairment at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation. Schutt, RK., Xie, H., Mueser, KT., et al.[2022]

Cognitive enhancement (CE) interventions have shown potential to improve cognitive and psychosocial functioning in individuals with schizophrenia, which may lead to better employment opportunities and social relationships.

The paper emphasizes the need for evidence-based standards in CE programs to ensure effective implementation and funding, highlighting the importance of monitoring program performance and identifying individuals who would benefit most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health system funding of cognitive enhancement interventions for schizophrenia: summary and update of the New York Office of Mental Health expert panel and stakeholder meeting. McGurk, SR., Mueser, KT., Covell, NH., et al.[2018]

Cognitive Enhancement Therapy (CET) significantly improved emotional intelligence in individuals with early course schizophrenia, with a large effect size (Cohen's d=0.96) observed after one year of treatment.

Patients receiving CET showed marked improvements in understanding and managing emotions, suggesting that CET can effectively enhance social cognition in early-stage schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy improves emotional intelligence in early course schizophrenia: preliminary effects. Eack, SM., Hogarty, GE., Greenwald, DP., et al.[2022]

Cognitive Enhancement Therapy (CET) significantly improved negative symptoms in early course schizophrenia patients, with a medium effect size (d=0.61), particularly in areas like social withdrawal and affective flattening, compared to the control group.

Neurocognitive improvements during CET were linked to reductions in negative symptoms, suggesting that cognitive rehabilitation can be beneficial not only for cognitive deficits but also for negative symptoms in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. Eack, SM., Mesholam-Gately, RI., Greenwald, DP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8888780/

Confirmatory Efficacy of Cognitive Enhancement Therapy ... Relative to EST, those treated with CET had significantly greater improvements in neurocognition (d = 0.46), social cognition (d = 1.55), social ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0005796725000130

Effectiveness of cognitive behavioral therapy for adult ... Patients (n = 6460) showed significant improvements in the primary outcome of psychological distress as measured with the GSI, MPre (SD) = 1.04 (0.62), MPost ( ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-04149-x

Cognitive Enhancement Therapy vs social skills training in ... This study builds on prior research on psychosocial rehabilitation by comparing the effectiveness of two treatments demonstrated as efficacious in improving ...

4. mdpi.com mdpi.com/2077-0383/13/15/4348

A Systematic Review and Narrative Synthesis of Cognitive ... Approximately 67% of studies reported significant improvements in at least one trained domain of cognitive function after CT, and 47% observed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698422/

Analysis of the effectiveness of cognitive rehabilitation for ... The meta-analysis showed that cognitive rehabilitation treatment applied to patients with chronic mental illness was effective in improving cognitive function ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9434502/

Cognitive Enhancement Therapy vs social skills training in ... Cognitive Enhancement Therapy is a comprehensive cognitive remediation program designed to maximize gains in social functioning by integrating ...

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2015.14030374

Cognitive Enhancement Treatment for People With Mental ... This study evaluated a cognitive enhancement program to improve cognition and competitive employment in people with mental illness who had not ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6178894/

Current Status of Cognitive Remediation for Psychiatric ... The effects of CR on depressive symptom and psychosocial function further suggest that CR can be a treatment option for MDD. It should be noted, ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02459210

Adaptation of Cognitive Enhancement Therapy for Persons ... The purpose of this study is to test the feasibility of a modification of CET (Cognitive Enhancement Therapy) to address symptomatic and functional ...

10. withpower.com withpower.com/trial/phase-mental-disorders-11-2020-55a8b?lat=34.60184&lng=-117.81218

Cognitive Enhancement Therapy vs. Social Skills Training ... Research indicates that Cognitive Enhancement Therapy and Social Skills Training are generally safe for humans, as they have been used effectively in treating ...