Clinical trial NCT03467243: Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training
Official title: Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Serious Mental Illness
Keywords: schizophrenia
Veterans
depression
peer specialist
social skills training
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-03-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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, our 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. Our 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 and Peer Specialist-led manualized groups of equal duration and treatment as usual. We 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 CBSST 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). We 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. We will evaluate the effect for treatment conditions (CBSST-Peer vs. SST-Peer vs. treatment as usual) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Independent Living Skills Survey (ILSS) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Abbreviated Quality of Life Scale (A-QLS) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Psychosocial Rehabilitation (PSR) Toolkit Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Recovery Assessment Scale (RAS) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Patient Activation Measure (PAM) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Defeatist Performance Attitude Scale (DPAS) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Comprehensive Modules Test (CMT) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Brief Psychiatric Rating Scale (BPRS) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
measure: Clinical Assessment Interview for Negative Symptoms (CAINS) Change
timeFrame: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and 3-month post-intervention follow-up (32 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Matthew J. Chinman, PhD
role: PRINCIPAL_INVESTIGATOR
References: