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Serious Mental Illness clinical trials

View clinical trials related to Serious Mental Illness.

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NCT ID: NCT06384521 Not yet recruiting - Schizophrenia Clinical Trials

Lifestyle MIND- Feasibility for Randomized Wait-list Control Trial

MIND
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are: - Does Lifestyle MIND improve diabetes control among people with SMI? - Will the effect of Lifestyle MIND be sustained 10 weeks after program completion? - From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI? Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being.

NCT ID: NCT06370767 Not yet recruiting - Clinical trials for Serious Mental Illness

Peer Facilitated Waitlist Controlled Transportation Study

Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses: 1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills. 2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community. 3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention. Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews.

NCT ID: NCT06078293 Not yet recruiting - Clinical trials for Serious Mental Illness

Home-based Exercise for SMI

Start date: August 3, 2026
Phase: N/A
Study type: Interventional

Older Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have reduced physical function (endurance, strength, mobility) that leads to lower quality of life. Exercise interventions are effective at improving physical function and could have a tremendous impact on this population. Despite the established benefits of exercise, there has been little work focused on improving multiple aspects of physical function in older Veterans with serious mental illness. The purpose of this study is to examine the feasibility and acceptability of a home-based exercise program for older Veterans with serious mental illness.

NCT ID: NCT05807867 Not yet recruiting - Hiv Clinical Trials

RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom exacerbation, which are made worse by stigma and threaten antiretroviral therapy (ART) adherence. The investigators propose to test an intervention to reduce stigma due to the statuses of SMI and HIV, against an attention control condition, in the high-risk transition period after discharge from an initial psychiatric hospitalization. Specifically, the investigators are conducting a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of 1) What Matters Most (WMM)-based intersectional stigma intervention delivered as clients transition from psychiatric hospitalization to outpatient care; and 2) an attention placebo control condition that follows a similar format to isolate the effects of the intervention. The investigators will also assess policymaker workshops where peer women with SMI and HIV co-lead the reporting of RCT findings via lived experience to policymakers to initiate structural change. Enabling women with SMI and HIV to resist stigma has the potential to improve their HIV outcomes and empower these women to elicit broader, structural-level change.

NCT ID: NCT04560335 Recruiting - Clinical trials for Serious Mental Illness

Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness

C2F
Start date: August 2, 2021
Phase: Phase 3
Study type: Interventional

This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools. Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight

NCT ID: NCT03627377 Recruiting - Obesity Clinical Trials

Multi-component Intervention for Diabetes in Adults With Serious Mental Illness

MIDAS
Start date: December 28, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03467243 Recruiting - Clinical trials for Serious Mental Illness

Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training

CBSST-PEER
Start date: August 15, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03069482 Completed - Nicotine Addiction Clinical Trials

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

Start date: May 15, 2017
Phase: Phase 1
Study type: Interventional

Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures. Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness. However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population? Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.

NCT ID: NCT02469389 Completed - Schizophrenia Clinical Trials

Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia

Start date: August 3, 2015
Phase: N/A
Study type: Interventional

The goal of this project is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.

NCT ID: NCT02420340 Completed - Clinical trials for Serious Mental Illness

Using The HOPES Program in Transition Care

Start date: September 2014
Phase: N/A
Study type: Interventional

This pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (SMI), the Helping Older People Experience Success (HOPES) program, to help nursing home residents with SMI gain the skills needed to successfully live in the community.