Psychosocial Interventions for Schizophrenia

Overseen By Jennifer Sabbagh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Organic brain syndrome, Severe substance use, Intellectual disability

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well certain therapies can help people with schizophrenia improve their social skills and daily functioning. Researchers focus on two treatments: Cognitive Enhancement Therapy, which uses computer-based and group exercises to boost thinking and social skills, and Social Skills Training, which involves practicing everyday interactions to enhance psychosocial health. The goal is to determine who benefits most from these therapies by using simple smell tests. Suitable participants have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder and do not have major substance issues or intellectual disabilities. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving therapies for schizophrenia.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these psychosocial interventions are safe for individuals with schizophrenia?

Research has shown that both Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) are generally safe for people with schizophrenia. Studies have found CET to be well-tolerated, with no unusual side effects compared to standard treatments for schizophrenia. This therapy uses computer exercises and group activities to enhance thinking and social skills.

Social Skills Training is also considered safe and focuses on improving social interactions and daily life skills. Techniques like role-playing and feedback enhance social abilities. Reports indicate no major safety concerns, and participants often find it helpful in managing symptoms.

Both therapies aim to improve social and thinking skills without adding significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for schizophrenia focus on managing symptoms with medication. But Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) offer something different. CET is unique because it integrates computer-based cognitive training with group exercises to boost both brain function and social skills, aiming to improve overall social functioning. SST, on the other hand, uses techniques like role-playing and real-world practice to enhance social interaction and preventive health. Researchers are excited about these approaches because they tackle the social and cognitive challenges of schizophrenia directly, potentially leading to more holistic improvements in patients’ lives.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that Cognitive Enhancement Therapy (CET), one of the treatments in this trial, improves thinking skills and social functioning in people with early schizophrenia. CET uses computer-based exercises and group activities to enhance both cognitive and social abilities. Studies have confirmed that CET reduces the difficulties caused by cognitive problems in schizophrenia.

Social Skills Training (SST) is another treatment option in this trial. It focuses on teaching social skills, such as communication, through practice and feedback. Research indicates that SST improves social interactions and reduces relapse rates compared to standard care. Both treatments show promise in addressing challenges related to schizophrenia. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 65 with a diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder. It's not suitable for those with severe substance use disorders, intellectual disabilities, or organic brain syndromes as per DSM-5 criteria.

Inclusion Criteria

I have been diagnosed with schizophrenia or a related disorder.

Exclusion Criteria

Intellectual disability (DSM-5)

Presence of a current and severe substance use disorder (DSM-5)

Presence of a current organic brain syndrome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo psychosocial interventions including Cognitive Enhancement Therapy and Social Skills Training

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for changes in social adjustment, quality of life, and social skills performance

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Enhancement Therapy
• Social Skills Training

Trial Overview

The study aims to see if a person's sense of smell can predict who will benefit from social skills training and cognitive enhancement therapy in treating schizophrenia.

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+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

Social Cognition and Interaction Training (SCIT) is a feasible and well-accepted intervention for improving social functioning in individuals with schizophrenia in forensic wards, with participants reporting increased confidence and achievement of social goals.

Participants receiving SCIT showed significant improvements in facial affect recognition compared to those receiving treatment as usual, highlighting its potential efficacy in enhancing social cognition skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tackling Social Cognition in Schizophrenia: A Randomized Feasibility Trial. Taylor, R., Cella, M., Csipke, E., et al.[2022]

In a 2-year trial involving 58 early-course schizophrenia patients, cognitive enhancement therapy (CET) led to significant improvements in both neurocognition, particularly executive functioning, and social cognition, specifically emotion management.

These cognitive improvements were found to mediate functional outcomes, suggesting that effective cognitive rehabilitation should address both social and non-social cognitive deficits to enhance overall functioning in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of functional improvement in a 2-year trial of cognitive enhancement therapy for early schizophrenia. Eack, SM., Pogue-Geile, MF., Greenwald, DP., et al.[2022]

A quasi-experimental study involving 31 outpatients with schizophrenia showed that Social Cognition and Interaction Training (SCIT) combined with standard treatment significantly improved emotion perception and social skills compared to standard treatment alone.

SCIT is a promising intervention targeting social cognition, which may lead to better social functioning outcomes in individuals with schizophrenia, addressing a core deficit that traditional treatments have not effectively improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social cognition and interaction training (SCIT) for outpatients with schizophrenia: a preliminary study. Roberts, DL., Penn, DL.[2022]

Social skills training (SST) has limited effectiveness for individuals with schizophrenia, prompting the development of a new approach called metacognition-oriented social skills training (MOSST) that integrates metacognitive remediation to enhance social functioning.

A case study demonstrated successful completion of the MOSST program, suggesting that combining social skills training with metacognitive strategies may improve social skills in individuals with schizophrenia, warranting further empirical research to test its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognition-oriented social skills training for individuals with long-term schizophrenia: methodology and clinical illustration. Ottavi, P., D'Alia, D., Lysaker, P., et al.[2014]

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 effective for individuals with schizophrenia, helping them acquire essential interpersonal and independent living skills, which can improve their functioning in the community.

Recent advancements in social skills training have tailored approaches for various groups, including those with dual diagnoses and older adults, enhancing the generalization of skills to real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in social skills training for schizophrenia. Kopelowicz, A., Liberman, RP., Zarate, R.[2022]

In a 14-week study involving schizophrenia patients, those who participated in family-assisted social cognitive training (F-SCIT) showed significant improvements in quality of life, social functioning, and social cognition compared to those receiving social stimulation (SS).

The SS group, which had less frequent interactions, experienced a decline in nearly all measured outcomes, highlighting the effectiveness of incorporating family support in cognitive training for better rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of family involvement on social cognition training in clinically stable outpatients with schizophrenia -- a randomized pilot study. Tas, C., Danaci, AE., Cubukcuoglu, Z., et al.[2018]

Cognitive enhancement therapy (CET) significantly improved cognitive and functional outcomes in early-course schizophrenia patients over two years, particularly in social cognition and symptom management, compared to enriched supportive therapy (EST).

After two years, CET showed moderate effects on neurocognitive function and strong improvements in social adjustment and negative symptoms, suggesting that early cognitive rehabilitation can help reduce disability in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy for early-course schizophrenia: effects of a two-year randomized controlled trial. Eack, SM., Greenwald, DP., Hogarty, SS., et al.[2022]

Cognitive enhancement therapy (CET) for first-episode schizophrenia effectively combines supportive therapy with social skills and cognitive training, aiming to improve cognitive and negative symptoms in a motivational format.

The therapy emphasizes a strong therapeutic alliance, allowing clinicians to use techniques like errorless learning and positive reinforcement, making it adaptable for both group and individual treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive enhancement therapy: a therapeutic treatment strategy for first-episode schizophrenia patients. Miller, R., Mason, SE.[2019]

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