Peer-Delivered Cognitive Behavioral Social Skills Training for Serious Mental Illness

(CBSST-PEER Trial)

Overseen By Jessica R Dodge, PhD MSW MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Medication changes, Recent CBSST/CBT/SST, Hospitalization, Severe mental illness, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 21

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Veterans with serious mental illness (SMI), such as schizophrenia or bipolar disorder with psychotic features, can benefit from social skills training led by Peer Specialists. The study compares two approaches: Cognitive Behavioral Social Skills Training (CBSST) and basic Social Skills Training (SST), both guided by peers with personal experience of SMI. The goal is to increase access to effective therapies by using trained peers instead of traditional therapists. Veterans with a primary diagnosis of SMI who are fluent in English might be suitable candidates for this study. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative therapies guided by peers who truly understand their experiences.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does exclude participants who have had medication changes in the past month. This suggests that stable medication use is preferred.

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

Research has shown that Cognitive Behavioral Social Skills Training (CBSST) effectively and safely aids people with serious mental illnesses like schizophrenia. In past studies, CBSST improved daily functioning and reduced symptoms without significant side effects. It combines elements of Cognitive Behavioral Therapy (CBT) and Social Skills Training (SST), both well-studied and generally manageable for participants.

Research indicates that Social Skills Training (SST) helps individuals with schizophrenia and similar conditions enhance their social skills through learning activities. SST has been found to reduce symptoms and improve social interactions. No major negative effects have been reported, confirming its safety.

Both CBSST and SST are considered safe and effective for serious mental illnesses, with no major safety concerns noted in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer-Delivered Cognitive Behavioral Social Skills Training (CBSST) and Social Skills Training (SST) for serious mental illness because these approaches offer a unique angle on therapy. Unlike traditional treatments that might focus solely on medication, these methods emphasize enhancing social skills and cognitive functioning through peer interaction. CBSST specifically combines cognitive behavioral strategies with social skills training, potentially offering a more comprehensive approach to improving everyday functioning. SST, on the other hand, focuses on practical social skills development, which can directly impact the quality of life for individuals. By involving peers in the delivery, these techniques may also improve engagement and relatability, which can be crucial for therapeutic success.

What evidence suggests that this trial's treatments could be effective for serious mental illness?

Research has shown that Cognitive Behavioral Social Skills Training (CBSST), one of the treatments in this trial, benefits people with serious mental illnesses like schizophrenia. Studies have found that CBSST improves social skills and helps manage negative symptoms, which are major challenges in schizophrenia. It employs well-known cognitive-behavioral therapy methods to help individuals reach their recovery goals.

Social Skills Training (SST), another treatment option in this trial, also effectively improves social interactions for people with schizophrenia. It uses practical techniques to help individuals practice and enhance their social skills. This method has been successfully used in regular care to address social difficulties in schizophrenia. Both CBSST and SST, as separate arms in this trial, offer promising benefits for enhancing everyday functioning in those with serious mental illness. ^{1 2 3 6 7}

Who Is on the Research Team?

Matthew J. Chinman, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for Veterans fluent in English with a primary diagnosis of serious mental illness (SMI) like schizophrenia or bipolar disorder. They must be able to give informed consent and not have had recent changes in medication, hospitalizations, or similar treatments within the past year.

Inclusion Criteria

Fluent in English so as to be able to complete testing

Voluntary informed consent (must be able to be given by the patient)

My diagnosis is a severe mental illness like schizophrenia or bipolar disorder with psychosis.

Exclusion Criteria

I understand the information given to me about the clinical trial.

I can make decisions about my health care.

Women who are pregnant will be excluded from this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Veterans participate in 20 weekly group sessions using Cognitive Behavioral Social Skills Training (CBSST) or Social Skills Training (SST) models

20 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Social Skills Training
• Social Skills Training
• Treatment as usual

Trial Overview The study tests if Peer Specialists can effectively deliver Cognitive Behavioral Social Skills Training (CBSST) and Social Skills Training (SST) compared to usual treatment. It's a randomized trial where Veterans are assigned to one of three groups: CBSST-Peer, SST-Peer, or their regular treatment.

How Is the Trial Designed?

Group I: Treatment as usual Experimental Treatment 1 Intervention

Veterans receive treatment as usual

Group II: SST Experimental Treatment 1 Intervention

Veterans participate in 20 weekly group sessions using Social Skills Training model

Group III: CBSST Experimental Treatment 1 Intervention

Veterans participate in 20 weekly group sessions using Cognitive Behavioral Social Skills Training model

Cognitive Behavioral Social Skills Training is already approved in United States for the following indications:

Approved in United States as CBSST for:

• Schizophrenia
• Serious Mental Illness

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Cognitive-behavioural social skills training (CBSST) was found to be feasible and well-accepted among 22 participants with first-episode psychosis over an 18-week program.

Participants showed significant improvements in adaptive functioning, which were maintained even 3 months after the program ended, suggesting potential long-term benefits of CBSST.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioural social skills training for first-episode psychosis: a feasibility study. Herman, Y., Shireen, H., Bromley, S., et al.[2019]

In a pilot study involving 12 Veterans with serious mental illness, peer specialists effectively delivered Cognitive-Behavioral Social Skills Training (CBSST), resulting in significant improvements in symptoms, hope, defeatist attitudes, and skill learning over a 12-week period.

The fidelity of the peer specialists' delivery of the training was rated highly, indicating that they met the competence threshold, suggesting that peer-delivered interventions could enhance mental health services for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Test of Using Peer Specialists to Deliver Cognitive-Behavioral Social Skills Training. Chinman, M., McCarthy, S., Holden, J., et al.[2023]

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 study of 76 middle-aged and older patients with chronic schizophrenia, those who received cognitive behavioral social skills training alongside standard treatment showed significant improvements in social functioning activities and cognitive insight after 24 weeks of training.

While overall symptoms did not significantly differ between groups, the increase in cognitive insight from the combined treatment was linked to a greater reduction in positive psychotic symptoms, suggesting that enhancing cognitive insight may help in managing psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. Granholm, E., McQuaid, JR., McClure, FS., et al.[2018]

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]

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 will evaluate the effectiveness of peer specialists delivering social skills training (SST) and cognitive behavioral social skills training (CBSST) to 252 veterans with serious mental illness (SMI), aiming to improve treatment engagement and outcomes.

The study uses a randomized trial design over 20 weeks, with the Independent Living Skills Survey as the primary outcome measure, to assess whether peer-led interventions can enhance accessibility and effectiveness compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer specialists deliver cognitive behavioral social skills training compared to social skills training and treatment as usual to veterans with serious mental illness: study protocol for a randomized controlled trial. Mitchell-Miland, C., McCarthy, S., Chinman, M.[2022]

A one-year study focused on social skills training for patients with schizophrenia aimed to improve their ability to live independently by using techniques like role playing, positive reinforcement, and cognitive approaches.

The training included modeling and videotape materials to address attention and information processing deficits, highlighting a comprehensive method to enhance social skills in individuals diagnosed with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of communication disorders in the schizophrenic. Experience at the Brentwood VA Hospital in California]. Langeard, J.[2019]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4244255/

Randomized Clinical Trial of Cognitive Behavioral Social ... ... CBT for psychosis effectiveness trial conducted in a community mental health setting. ... outcomes in some consumers with schizophrenia. Acknowledgments. We ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34665853/

Effects in a Pilot Randomized Controlled Trial - PubMed - NIH Objective: Negative symptoms and cognitive impairment in schizophrenia (SZ) remain unmet treatment needs as they are highly prevalent, ...

3. healthiershelby.com healthiershelby.com/promisepractice/index/view?pid=846

Cognitive Behavioral Social Skills Training Cognitive Behavioral Social Skills Training (CBSST) is a program for middle-aged and older outpatients with chronic schizophrenia.

4. cbsst.org cbsst.org/

Cognitive Behavioral Social Skills Training ... serious mental illness, such as schizophrenia. Building upon previously validated treatment approaches, Eric Granholm, Ph.D. and his colleagues developed ...

5. amazon.com amazon.com/Cognitive-Behavioral-Social-Skills-Training-Schizophrenia/dp/1462524710

Cognitive-Behavioral Social Skills Training for ... This manual presents cognitive-behavioral social skills training (CBSST), an intervention that helps clients with schizophrenia achieve recovery goals related ...

6. academic.oup.com academic.oup.com/schizophreniabulletin/article/48/2/359/6403384

Integrated Cognitive-Behavioral Social Skills Training and ... CBSST combines elements of Cognitive Behavioral Therapy (CBT) and Social Skills Training (SST), both evidence-based treatments for schizophrenia ...

7. dokumen.pub dokumen.pub/cognitive-behavioral-social-skills-training-for-schizophrenia-a-practical-treatment-guide-9781462524716.html

Cognitive-Behavioral Social Skills Training for Schizophrenia CBSST was designed to address key factors that influence functional outcome in schizophrenia, such as dysfunctional attitudes, low motivation, social skills ...