Peer-Delivered Cognitive Behavioral Social Skills Training for Serious Mental Illness
(CBSST-PEER Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Medication changes, Recent CBSST/CBT/SST, Hospitalization, Severe mental illness, Cognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The Veterans Health Administration (VHA) is advocating that Veterans with serious mental illness (SMI) receive recovery-oriented, rehabilitation approaches that target real-world functioning. One such approach is Cognitive-Behavioral Social Skills Training (CBSST). Unlike traditional cognitive-behavioral therapy, CBSST is a more recovery-oriented psychosocial rehabilitation intervention that teaches Veterans with SMI to correct errors in thinking and build social skills. While effective, CBSST has only been tested when facilitated by masters- or doctoral-level therapists, which limits its use in VHA. However, the investigators' pilot data shows that Peer Specialists-individuals with SMI who are hired and trained to use their own recovery experience to assist others with SMI-can also provide CBSST (called CBSST-Peer). Stand-alone social skills training (SST) is also a recovery-oriented program that VHA is attempting to rollout nationwide for Veterans with SMI. A few Peer Specialists have been trained to co-lead SST with professionals. However, SST is not widely implemented because professionals are busy and Peer Specialist delivered SST has not been tested. This study will evaluate the effectiveness of Peer Specialist-delivered CBSST and SST, which would increase access Veterans with SMI have to effective treatment. The investigators' aims are: Aim 1 (Effectiveness): To compare the impact of CBSST-Peer on outcomes in Veterans with SMI to Veterans receiving Peer Specialist-delivered SST groups of equal duration and to treatment as usual. The investigators will also assess fidelity of SST and CBSST. Aim 2: (Helpfulness of CBSST/SST--Peer and implementation barriers and facilitators): To use focus groups with patients and interviews with Peer Specialists and other staff to assess perceptions of SST- and CBSS Peer and identify potential barriers and facilitators to future implementation. Methods: This is a randomized, Hybrid 1 trial involving 252 Veterans with SMI (n=126 each from Pittsburgh, San Diego) comparing 3 treatment arms: CBSST-Peer vs. SST-Peer vs. treatment as usual. Hybrid 1 trials test the effectiveness of an intervention and collect implementation data that could inform its future adoption. At each site, across 6 waves (a wave = 1 CBSST-Peer and 1 SST-Peer group), 2 Peer Specialists will co-lead 12 groups, each lasting 20 weeks. Peer Specialists will be trained and receive an hour of supervision weekly by the CBSST developers. Master trainers from the SST rollout will train and supervise Peer Specialists in each site. All three arms' sessions will be taped and 25% rated for fidelity on standardized measures. A survey battery that assesses functioning, quality of life, recovery, and symptoms will be administered to the Veterans in each wave at: baseline, mid-intervention (10 weeks), end-of-intervention (20 weeks), and follow-up (32 weeks, 3 months post intervention). The investigators will examine all outcomes using Hierarchical Linear Models (HLM), with treatment condition included as a time-invariant covariate, and random intercepts for person and random slopes for time. Relevant covariates will include site, treatment attendance, symptom severity, service use, and demographic variables. The investigators will evaluate the effect for treatment conditions (CBSST-Peer vs. SST-Peer vs. treatment as usual group) in the expected direction and the time X group effect. Qualitative data on SST- and CBSST-Peer helpfulness and implementation factors will be collected from 8 focus groups, audio-recorded from a random sample of Veterans who participated in SST- and CBSST-Peer. Interviews will be conducted with participating Peer Specialists (n=approximately 8 per site), and key mental health staff (n=3-4 per site). The qualitative interviews and focus groups will be analyzed using rapid assessment, a team-based, iterative data collection and analysis approach providing data on the barriers and facilitators to future implementation of SST- and CBSST-Peer. Innovation: No study has tested peer-delivered SST or CBSST, or compared the two, in a rigorous trial. Significance/Expected Results: CBSST and SST are not widely available. If SST- or CBSST-Peer is effective, it could greatly increase the delivery of evidence-based services Veterans receive and enhance the services by VHA Peer Specialists.
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.
What data supports the effectiveness of the treatment Cognitive Behavioral Social Skills Training for Serious Mental Illness?
Research shows that Cognitive Behavioral Social Skills Training (CBSST) can improve symptoms, hope, and skill learning in people with serious mental illness, including schizophrenia. Studies have found that CBSST helps patients learn social and independent living skills, and when delivered by peer specialists, it can lead to significant improvements in symptoms and attitudes.
12345Is Peer-Delivered Cognitive Behavioral Social Skills Training safe for humans?
Research on Cognitive Behavioral Social Skills Training (CBSST) and similar programs for schizophrenia and other mental disorders suggests that these treatments are generally safe for humans. They focus on teaching social and independent living skills, and no significant safety concerns have been reported in the studies.
24567How is the treatment Cognitive Behavioral Social Skills Training (CBSST) for serious mental illness different from other treatments?
Cognitive Behavioral Social Skills Training (CBSST) is unique because it combines cognitive and behavioral techniques with social skills training, and it can be delivered by peer specialists (individuals with similar experiences) to improve engagement and accessibility for those with serious mental illness. This approach not only addresses symptoms but also focuses on enhancing social functioning and independent living skills, which are crucial for recovery.
23489Eligibility Criteria
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
+6 more
Trial Timeline
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)
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Treatment as usualExperimental Treatment1 Intervention
Veterans receive treatment as usual
Group II: SSTExperimental Treatment1 Intervention
Veterans participate in 20 weekly group sessions using Social Skills Training model
Group III: CBSSTExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Reducing negative symptoms in schizophrenia: Feasibility and acceptability of a combined cognitive-behavioral social skills training and compensatory cognitive training intervention. [2022]The current study examined the feasibility and acceptability of an integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention compared with Goal-Focused Supportive Contact (SC) in a pilot randomized controlled trial for people with schizophrenia with high negative symptom severity. The sample included 55 participants from five community settings; masters-level study clinicians delivered interventions on-site. Participants completed assessments of cognitive, functional, and psychiatric symptoms at baseline, mid-treatment, post-treatment (12.5 weeks), and 6-month follow-up. Enrollment goals were not initially met, necessitating the addition of a fifth site; however, all groups and assessments were completed on-site. Study procedures were acceptable, as evidenced by 100% enrollment and completion of baseline assessments following informed consent; however, over 1/3rd of participants dropped out. No modifications were necessary to the intervention procedures and CBSST-CCT fidelity ratings were acceptable. The intervention was deemed acceptable among participants who attended ≥1 session, as evidenced by similar attendance rates in CBSST-CCT compared to SC. Among CBSST-CCT participants, lower positive symptoms were significantly associated with better attendance. Overall, we found mixed evidence for the feasibility and acceptability of the CBSST-CCT protocol in people with schizophrenia with high negative symptoms. Challenges are highlighted and recommendations for future investigations are provided.
A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. [2018]The number of older patients with chronic schizophrenia is increasing. There is a need for empirically validated psychotherapy interventions for these patients. Cognitive behavioral social skills training teaches cognitive and behavioral coping techniques, social functioning skills, problem solving, and compensatory aids for neurocognitive impairments. The authors compared treatment as usual with the combination of treatment as usual plus cognitive behavioral social skills training.
Pilot Test of Using Peer Specialists to Deliver Cognitive-Behavioral Social Skills Training. [2023]A pilot study of Veterans with serious mental illness assessed fidelity and preliminary outcomes of peer specialist (PS)-delivered Cognitive-Behavioral Social Skills Training (CBSST). A single-arm, baseline-post pilot involved 4 PSs and 12 Veterans, split between two sites. Five functioning and symptom measures were administered before and after the 12-week intervention. Half of all sessions were rated on a standardized fidelity measure. Four outcomes (symptoms, hope, defeatist attitudes, skill learning) showed statistically significant improvement. Effect sizes and fidelity ratings matched previous trials with the training, and the fidelity ratings exceeded the threshold for competence. Although more research is needed, PSs could improve services for serious mental illness by delivering structured interventions.
Recent advances in social skills training for schizophrenia. [2022]Social skills training consists of learning activities utilizing behavioral techniques that enable persons with schizophrenia and other disabling mental disorders to acquire interpersonal disease management and independent living skills for improved functioning in their communities. A large and growing body of research supports the efficacy and effectiveness of social skills training for schizophrenia. When the type and frequency of training is linked to the phase of the disorder, patients can learn and retain a wide variety of social and independent living skills. Generalization of the skills for use in everyday life occurs when patients are provided with opportunities, encouragement, and reinforcement for practicing the skills in relevant situations. Recent advances in skills training include special adaptations and applications for improved generalization of training into the community, short-term stays in psychiatric inpatient units, dually diagnosed substance abusing mentally ill, minority groups, amplifying supported employment, treatment refractory schizophrenia, older adults, overcoming cognitive deficits, and negative symptoms as well as the inclusion of social skills training as part of multidimensional treatment and rehabilitation programs.
Cognitive-behavioural social skills training for first-episode psychosis: a feasibility study. [2019]To conduct a preliminary feasibility examination of cognitive-behavioural social skills training (CBSST) in a first-episode psychosis population.
[Treatment of communication disorders in the schizophrenic. Experience at the Brentwood VA Hospital in California]. [2019]The author relates a one-year research experience on "social skills training" behavior therapies applied to DSM-III schizophrenic patients. Besides role playing, positive reinforcement and generalization, a cognitive approach to attention and information processing deficits is described using modelling and videotape material. The objective is an intensive teaching of necessary skills for independent living.
Metacognition-oriented social skills training for individuals with long-term schizophrenia: methodology and clinical illustration. [2014]There is much evidence indicating the presence of social deficits in schizophrenia and the detrimental effect of these deficits on global functioning in this population. As a result, social skills training (SST) has emerged as a legitimate psychosocial treatment, although effectiveness research has revealed small effect sizes and limited generalizability regarding the benefits of this treatment.
Tackling Social Cognition in Schizophrenia: A Randomized Feasibility Trial. [2022]Social cognition difficulties in schizophrenia are seen as a barrier to recovery. Intervention tackling problems in this domain have the potential to facilitate functioning and recovery. Social Cognition and Interaction Training (SCIT) is a manual-based psychological therapy designed to improve social functioning in schizophrenia.
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. [2022]Serious mental illness (SMI) affects 4.6% of the American population. While treatments are available, adherence to specific regimens is often suboptimal. Multiple organizations, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), have called for more options that improve accessibility and engagement to treatment among individuals with SMI. This study protocol answers such calls by testing the effectiveness of peer specialists-individuals with SMI trained to use their experience to help others with SMI-in delivering social skills training (SST) and cognitive behavioral social skills training (CBSST), evidence-based treatments effective at engaging individuals with SMI to make behavioral and cognitive changes. Peer specialists have been shown to be adept at engaging those with SMI in treatment; however, their ability to deliver these structured treatments is unknown.