Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training (CBSST-PEER)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jessica R Dodge, PhD MSW MPH
- Phone Number: (734) 845-3609
- Email: Jessica.Dodge@va.gov
Study Contact Backup
- Name: Matthew J Chinman, PhD
- Phone Number: (412) 360-2438
- Email: matthew.chinman@va.gov
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntary informed consent (must be able to be given by the patient)
Primary diagnosis of SMI documented in the medical record
- schizophrenia
- schizoaffective disorder
- bipolar disorder with psychotic features
- Fluent in English so as to be able to complete testing
Exclusion Criteria:
- Medication changes in the prior month
- Current or recent (within the past year) CBSST, CBT, or SST (so any skill knowledge and any improvement in outcome can be attributed to SST- or CBSST-Peer rather than participation in other forms of current or recent CBT or SST interventions)
- Level of care at baseline that interferes with outpatient participation
Current hospitalization for psychiatric, substance use or physical illness
- hospitalized subjects will be invited to participate 1 month after discharge
- Severe and/or unstable mental illness as indicated during informed consent process by inability to pass the Blessed measure in the first visit
- Cognitive impairment as indicated by inability to pass the 10 item T/F measure about informed consent
- Women who are pregnant will be excluded from this study
- Incarcerated Veterans will be excluded from this study
- Veterans with impaired decision making capabilities will be excluded from this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: CBSST
Veterans participate in 20 weekly group sessions using Cognitive Behavioral Social Skills Training model
|
CBSST is a more recovery-oriented psychosocial rehabilitation intervention that helps Veterans with SMI set goals, correct errors in thinking, and build communication skills to improve social functioning
Other Names:
|
|
Experimental: SST
Veterans participate in 20 weekly group sessions using Social Skills Training model
|
SST is an evidence-based, manualized, goal setting curricula that teaches social skills, for example: communication skills and listening skills for Veterans with Serious mental Illness.
Other Names:
|
|
Other: Treatment as usual
Veterans receive treatment as usual
|
TAU is when Veterans continue to receive their usual care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Independent Living Skills Survey (ILSS) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The ILSS is a self-report measure of everyday functional living skills for patients with SMI that has proven to be reliable, stable, sensitive, and valid in multiple samples.
The 51-item yes-no questionnaire takes less than 10 minutes to administer and assesses whether or not specific functioning behaviors have been performed over the past month in 10 areas: Personal Hygiene, Appearance and Care of Clothing, Care of Personal Possessions (everyday household chores), Food Preparation, Health Maintenance, Money Management, Transportation, Leisure and Community (including socialization), Job Seeking, and Job Maintenance.
Items in each domain are averaged, and a total average score is computed.
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Abbreviated Quality of Life Scale (A-QLS) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The A-QLS is a 10-minute semi-structured interview administered by a trained research assistant that measures subjective and objective aspects of functioning on 8 items in the past 4 weeks (total score will be used).
The full 21-item QLS is one of the most commonly used measures of social and occupational role functioning in schizophrenia treatment outcome research, and the abbreviated version is well-validated and strongly correlated with the parent form (r=.96-.98).
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Psychosocial Rehabilitation (PSR) Toolkit Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The PSR Toolkit is a 10-minute interview used to collect information on employment, educational activity, and residential situation.
In this brief interview, status in each functioning domain is rated on a progressive scale, ranging from the absence of meaningful functioning in the domain to fully independent functioning (e.g., for Employment: 1= no employment, 2=non-paid work, 3= sheltered workshops .
11= independent competitive employment).
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Recovery Assessment Scale (RAS) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The RAS is a 10-minute checklist that assesses aspects of recovery with a special focus on hope and self-determination.
The RAS has 41 items on which respondents rate themselves using a 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree.
The RAS is intended for use and has been tested with patients with SMI who receive services in outpatient settings and in peer-run programs.
The RAS's subscales measure five domains: Personal Confidence and Hope, Willingness to Ask for Help, Goal and Success Orientation, Reliance on Others, No Domination by Symptoms.
The alphas for the total score and the five factors range from 0.74 to 0.87; test-retest correlation for the total score two weeks apart was r=.88; and the total score has demonstrated congruence with other similar concepts including a self-esteem80= 0.55, social support = 0.48, and subjective quality of life = 0.62.
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Patient Activation Measure (PAM) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
Patient activation refers to the knowledge, skills, confidence, and attitudes patients have for managing health and treatment.
Several studies in medical domains have found that individuals with higher activation are healthier, report a better quality of life, are more satisfied with treatment, and engage in more health care practices.
As recovery involves an active role for people with SMI in developing a life beyond illness, activation can be a central construct in assessing the recovery impact of a new service like PSs.
The shortened PAM is a 5-minute,13-item measure.
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Defeatist Performance Attitude Scale (DPAS) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The DPAS is a 15-item, 5-minute self-report subscale of the commonly-used 40-item Dysfunctional Attitude Scale (DAS) derived from factor analysis.
The DPAS indexes defeatist attitudes about one's ability to perform tasks (e.g., "If you cannot do something well, there is little point in doing it at all", "If I fail at my work, then I am a failure as a person").
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baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Comprehensive Modules Test (CMT) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The CMT is a 15-minute interview assessing mastery of the content in the 2 CBSST modules and has been used in all prior CBSST trials.9,
53, 54 Questions with vignettes were developed to assess mastery of thought challenging (max=11) and social communication (max =11) skill knowledge.
The CMT total score (max=22) will be used.
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Brief Psychiatric Rating Scale (BPRS) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The 24 item BPRS total score will be used to measure global psychopathology.
The four BPRS positive symptom items - conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content - will be used to measure positive psychotic symptoms.
The BPRS is one of the most widely-used instruments measuring severity of various psychiatric symptoms and has well documented psychometric properties.
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
|
Clinical Assessment Interview for Negative Symptoms (CAINS) Change
Time Frame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
The investigators will also use the CAINS as it was developed to better capture experiential deficits (amotivation and asociality) and we found that these symptoms did improve in a prior CBSST trial.
The 13 CAINS items are rated 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains.
It has demonstrated good inter-rater reliability (ICCs=.77-.93),
test-retest stability (r=.69), and convergent and discriminant validity.
|
baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Matthew J. Chinman, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IIR 16-214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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