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

201 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 4 5 6 7}

How 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. ^{2 3 4 8 9}

Research Team

Matthew J. Chinman, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Ireland 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot Test of Using Peer Specialists to Deliver Cognitive-Behavioral Social Skills Training. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Recent advances in social skills training for schizophrenia. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Cognitive-behavioural social skills training for first-episode psychosis: a feasibility study. [2019]

6. Belgium pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Metacognition-oriented social skills training for individuals with long-term schizophrenia: methodology and clinical illustration. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Tackling Social Cognition in Schizophrenia: A Randomized Feasibility Trial. [2022]

9. England 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. [2022]