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Peer-Delivered Cognitive Behavioral Social Skills Training for Serious Mental Illness (CBSST-PEER Trial)

N/A

Recruiting

Led By Matthew J. Chinman, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis of SMI documented in the medical record (schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features)

Be older than 18 years old

Must not have

Cognitive impairment as indicated by inability to pass the 10 item T/F measure about informed consent

Veterans with impaired decision making capabilities will be excluded from this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the impacts of two different types of social skills training - one delivered by peers and one by professionals - on veterans with serious mental illness to see which is more effective. The study will also assess fidelity of the social skills training and identify potential barriers and facilitators to future implementation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychosocial interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal experiences or changing behavior patterns during training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I can make decisions about my health care.

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My current care needs prevent me from participating in outpatient activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks) for reporting.