Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training (CBSST-PEER)
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|ClinicalTrials.gov Identifier: NCT03467243|
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Serious Mental Illness||Behavioral: Cognitive Behavioral Social Skills Training Behavioral: Social Skills Training Behavioral: Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Cognitive Behavioral Social Skills Training for Peer Specialists (CBSST-Peer). At each site, two PSs will co-lead a series of 20 weekly, 60-minute CBSST-Peer classes, grouped into two 10-class "modules": the Cognitive Skills Module and the Social Skills Module. The treatment manual includes a patient workbook and includes homework assignments.
Social Skills Training-Peer. These groups will run according to the Bellack et al. model used in VA's SST rollout. Groups will use behavioral rehearsal role play to improve communication and interaction skills Treatment as usual group. Participants will continue to receive treatment as they normally would.
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Research assistants administering the outcomes measures will be blinded to the Veteran's treatment condition.|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training|
|Actual Study Start Date :||August 15, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Veterans participate in 20 weekly group sessions using Cognitive Behavioral Social Skills Training model
Behavioral: Cognitive Behavioral Social Skills Training
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 Name: CBSST
Veterans participate in 20 weekly group sessions using Social Skills Training model
Behavioral: Social Skills Training
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 Name: SST
Treatment as usual
Veterans receive treatment as usual
Behavioral: Treatment as usual
TAU is when Veterans continue to receive their usual care.
Other Name: TAU
- 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.
- 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).
- 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).
- 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.
- 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.
- 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").
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467243
|Contact: Matthew J Chinman, PhD||(412) firstname.lastname@example.org|
|Contact: Sharon A McCarthy, PhD MSW MBA||(412) 360-2847||Sharon.McCarthy@va.gov|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Not yet recruiting|
|San Diego, California, United States, 92161|
|Contact: Eric L Granholm, PhD 858-552-8585 ext 7563 email@example.com|
|Contact: Jason L Holden, PhD (858) 552-8585 ext 1265 firstname.lastname@example.org|
|Sub-Investigator: Eric L Granholm, PhD|
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15240|
|Contact: Matthew J Chinman, PhD 412-360-2438 email@example.com|
|Contact: Sharon A McCarthy, PhD MSW MBA (412) 360-2847 Sharon.McCarthy@va.gov|
|Sub-Investigator: Keri L. Rodriguez, PhD|
|Principal Investigator: Matthew J. Chinman, PhD|
|Sub-Investigator: Sharon A. McCarthy, PhD MSW MBA|
|Principal Investigator:||Matthew J. Chinman, PhD||VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|