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

Trial Summary

What is the purpose of this trial?

To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two 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.

What data supports the effectiveness of the treatment Cognitive Enhancement Therapy for mental illness?

Research shows that Cognitive Enhancement Therapy (CET) significantly improves emotional intelligence and reduces negative symptoms like social withdrawal in people with early course schizophrenia. These improvements suggest CET can help with social and cognitive challenges in schizophrenia. ^{1 2 3 4 5}

Is Cognitive Enhancement Therapy or Social Skills Training safe for humans?

Research indicates that Cognitive Enhancement Therapy and Social Skills Training are generally safe for humans, as they have been used effectively in treating social and cognitive issues in conditions like schizophrenia without reported safety concerns. ^{1 2 4 5 6}

How is Cognitive Enhancement Therapy different from other treatments for mental illness?

Cognitive Enhancement Therapy (CET) is unique because it focuses on improving social cognition and cognitive processes through interactive software and group exercises, targeting social and cognitive deficits that are not addressed by standard drug treatments for schizophrenia. ^{1 3 5 7 8}

Research Team

Matcheri S Keshavan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Russell K Schutt, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

I am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Practice principles of cognitive enhancement therapy for schizophrenia. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy improves emotional intelligence in early course schizophrenia: preliminary effects. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy. [2021]

6. United States 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Psychological training to improve psychosocial function in patients with major depressive disorder: A randomised clinical trial. [2023]