Serious Mental Illness clinical trials at UC Health
3 in progress, 1 open to eligible people
open to eligible people ages 18-65
Persons with schizophrenia and other serious mental illnesses have a high risk for type 2 diabetes and an increased risk of premature mortality compared to the general population. The goals of the proposed study are to implement a multimodal lifestyle intervention to reduce that risk in these individuals living in residential care facilities, a common housing modality for people with serious mental illnesses. If successful, this intervention will lead to reduction in excess medical comorbidity and mortality in persons with serious mental illnesses.
Sorry, not currently recruiting here
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.
Sorry, in progress, not accepting new patients
The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the general population, meaning that those with a serious mental illness die, on average, 25 years earlier than those without an SMI. These deaths are largely attributed to preventable medical conditions, many of which are more common in the SMI population. The "Bridge" intervention is a peer navigator model that was developed to target factors that negatively impact healthcare access, utilization, and outcomes among individuals with serious mental illness (e.g., severe mood disorders and psychotic disorders). This intervention targets male and female, adult consumers across races/ethnicities and has been utilized by Pacific Clinics (Southern California's largest behavioral healthcare agency) and the Department of Mental Health of Los Angeles County to improve the health and quality of life for their consumers. Investigators will test the comparative effectiveness of a peer navigator intervention (the Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI consumers the skills to engage health care providers and to overcome motivational deficits in order to improve their health and healthcare use. The specific aims of this application are: 1. To use randomized methods to examine the effectiveness of the Bridge intervention on the health care utilization, satisfaction with care, health status, and health care self-management for a sample of individuals with severe mental illness receiving public mental health services in the community; 2. To use randomized methods to examine the effectiveness of the Bridge intervention on psychological and social well-being for a sample of individuals with severe mental illness receiving public mental health services in the community. Up to 146 participants in an Full Service Partnership (FSP) clinic operated by Pacific Clinics will be recruited to participate in an approximately 24 month long study of Bridge navigation. Participants will be randomly assigned to either treatment as usual (waitlist) or immediate intervention with the Bridge. Participants in both groups will complete three assessments (baseline, 6 months, 12 months) and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed at baseline and every three months of the study in order to ensure that the intervention is being implemented appropriately.