Clinical Research Directory

Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans

Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced veterans in permanent supportive housing.

Enhancing Wellness Through Affirming Services and Education

The goal of this treatment study is to learn about the mental health, substance use and physical health outcomes associated with participating in the EASE holistic behavioral health and wellness program for individuals seeking HIV prevention and/or living with HIV. The main questions it aims to answer are: 1. Do important health outcomes, including substance use, mental health and social support related outcomes of individuals who participated in the holistic behavioral health and wellness program change after study participation? 2. Does a tailored approach to meet the specific needs of different subpopulations including 1) older (40+) PLWH with or at risk for additional health comorbidities and 2) PLWH and/or young adults (18-40) seeking HIV prevention to improve health outcomes including improvement in health and health behaviors . Participants will be asked to: * participate in 6 months of behavioral health treatment tailored to their needs, which may include individual counseling, group counseling, case management, peer support, and related education. * Complete surveys at the time of study entry and 6 months later to measure changes in health outcomes over time.

Reentry Assist (R-Assist)

This project will aim to develop and pilot test, R-Assist, a mobile health application to support individuals with co-occurring substance use and mental health disorders (COD) in their recovery, who have recently released from a participating Massachusetts jail.

A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.

Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation

Depression and anxiety during and after pregnancy are common medical complications contributing to a rising maternal mortality rate. Home visiting programs can offer evidence-based interventions to improve mental health outcomes for a vulnerable pregnant population; however, barriers remain to achieving the full potential of these interventions. Our work will explore the impact of context on the implementation of a mental health intervention to provide action-based and impactful data that focuses on the lived experiences of the diverse populations served by home visiting programs in Iowa and Indiana.

A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.

Improving Care, Accelerating Recovery and Education

The goal of this clinical trial is to test the I-CARE program in children who are in a medical hospital awaiting inpatient mental health treatment. The main questions it aims to answer are: * Can the I-CARE program be used at the medical hospitals and do the patients and hospital staff like the program? * Does the I-CARE program lower patients' emotional distress, thoughts about suicide or suicide attempts? Patients will complete as many of the 7 I-CARE videos as possible during their stay at the medical hospital and fill out online surveys. There are workbook activities that go with each I-CARE video. A hospital staff member will help the patient do the videos and workbook activities.

Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH)

The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement. This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.

Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings. Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.

Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).

Police Officers' Mental Health and Occupational Health Monitoring

Police officers are subject to various occupational risk factors that can contribute to the development of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. A previous study observed a low rate of access to specialized care services. Furthermore, carrying a firearm can facilitate acts of self-harm.

Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum

Unhealthy alcohol use among women with and at risk for HIV can interrupt critical steps in the HIV prevention and care continuum, is associated with HIV transmission risk behaviors, and contributes to health disparities. Thus it is critical to accurately identify alcohol use and implement alcohol interventions among women with and at risk for HIV to optimize health outcomes. The proposed pilot study will examine the implementation and effects of a computer delivered brief alcohol intervention with peer navigation/Community Health Worker compared to usual care on alcohol use, linkage to health services, and uptake of HIV prevention practices.

Efficacy of the I-CARE Digital Health Intervention

When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3 I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.

Engaging Mental Health Services for Preschoolers at Risk

Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and PCP stakeholders to adapt NTRI-MH and created a web-based dashboard to monitor outcomes (Phase 1). Then, for phase 2, the investigators will conduct a feasibility study for caregivers of HStart preschoolers with MH symptoms, guided by ethno-racially matched family navigators and referrals by HStart teachers and PCPs (n=20). Further, for Aim 2, the investigators will pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group of caregivers who receive child behavior training (n=86). The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child emotion regulation. If the aims of the project are achieved, this study would have a large impact on early MH service use for ethno-racial minoritized young children with the potential to improve child MH outcomes.

Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers

This study tests the effectiveness of a community-based peer advocacy, mutual learning, and social support intervention (Refugee and Immigrant Well-being Project) to reduce several negative consequences of the COVID-19 pandemic that are disproportionately impacting Latinx and Black populations: psychological distress, financial problems, and daily stressors. In partnership with five community-based organizations that focus on mental health, legal, education, and youth issues with Latinx immigrants and African refugees, we will also be able to examine the effects of people's involvement with community-based organizations and local and state policy changes on their mental health, economic stability, stressors, and social support. This is important not only for Latinx and Black populations and the large number of immigrants and refugees in the United States and worldwide, but also because the intervention model and what we learn from this study have the potential to alleviate mental health disparities experienced by other marginalized populations who face unequal access to social and material resources, disproportionate exposure to trauma and stress, and worse consequences of the COVID-19 pandemic.

Virtual Reality for Vocational Recovery

Unemployment is higher among young people who experience mental ill-health compared to the general population. This can have a lasting impact on young people, many of whom are highly motivated to gain employment and education. There are many challenges to seeking, gaining, and maintaining employment for young people. To address these challenges and help young people meet their employment and education goals, investigators have developed a VR intervention to support vocational skill building. The aim of the current study is to evaluate the feasibility, acceptability, and safety, of the Virtual Reality for Vocational Recovery (VR4VR) intervention. A small group of vocational specialists will support up to 20 young people with their vocational outcomes using VR4VR over a 3-6week period. Both young people and specialists will complete questionnaires related to acceptability of the intervention, including qualitative interviews. Data on feasibility and safety will also be collected. Results will inform whether VR is feasible, acceptable, and safe to support vocational outcomes within vocational services that support young people with mental health difficulties, potentially supporting further intervention development and larger trials.

BECOME COmbined Intervention for MH & NCD Delivered by Community Health Workers in Nepal

Common mental health disorders (CMDs) and noncommunicable diseases (NCDs) pose significant public health challenges, especially in resource-limited settings like Nepal. The coexistence of CMDs and NCDs is prevalent, tied together by shared behavioral risk factors including stress, isolation, tobacco use, low physical activity, poor diet, and treatment non-adherence. Addressing these risk factors through behavioral interventions has the potential to positively impact both CMDs and NCDs. While the World Health Organization (WHO) recommends three behavioral interventions-evidence-based stress reduction (EBSR) for stress and anxiety, behavioral activation (BA) for depression, and motivational interviewing (MI) for healthy behaviors-availability remains scarce in low-resource settings. This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) in Nepal. BECOME, delivered by community health workers (CHWs), integrates EBSR, BA, and MI to improve mental health and address NCDs. The study employs a stepped-wedge cluster randomized trial, with 20 clusters randomly assigned to five steps, starting in the control condition. Transitioning every three months, clusters gradually adopt the intervention, minimizing logistical challenges during implementation. The study targets 600 patient participants (age 40 years and above with at least one CMD and NCD) from Bardibas and Chandragiri municipalities, involving 20 CHWs, five primary care providers (PCPs), and six health system leaders. CHWs identify potential participants, with research staff assessing eligibility, obtaining informed consent, and conducting baseline assessments using a digital REDCap tool. CHWs undergo BECOME intervention training, delivering it to consenting patient participants (30 per CHW). Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs. Additionally, qualitative components, following the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework, include focus group discussions (FGDs) with CHWs and Key Informant Interviews (KIIs) with patient participants, PCPs, and health system leaders to assess implementation mechanisms, outcomes, and clinical impact. The study, if successful, aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs.

Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders

The goal of this observational study is to understand the effects and experiences of therapeutic writing interventions in adult women with chronic pain and co-occurring mental health conditions. The main questions it aims to answer are: Can therapeutic writing help relieve chronic pain and emotional distress? How does writing support emotional processing, regulation, and meaning-making during rehabilitation? Participants will take part in a two-part writing intervention involving: Guided writing exercises that focus on emotional processing, emotion regulation, and creating meaning. Individual interviews after the writing sessions to explore their experiences. The study uses qualitative analysis methods-phenomenology and logotherapy-to better understand how these writing interventions may support recovery, improve well-being, and offer non-pharmacological tools for managing chronic pain and mental health challenges.

Supporting Treatment Access and Recovery in COD

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

Implementation and Evaluation of Primary Care Behavioral Health in Sweden

In this multicenter study, the investigators want to compare treatment outcomes for patients with mental and behavioral health problems in traditional primary care (Care As Usual, CAU) and primary care centres that work according to the Primary Care Behavioral Health (PCBH) model. In addition to this, the investigators want to study organisation-level outcomes, such as access to care, perceived teamwork and work environment. To achieve this, primary care centres that have expressed interest in implementing PCBH will be cluster randomised between implementing directly or waiting for implementation.

EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality

Health inequality and genetic disparity are a significant issue in the United Kingdom (UK). This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations. The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations. This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK. The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.

Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach

Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood. Aims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome. Methods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps. Species composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content. Expected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.

Regulated Cannabis Access in Basel

The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.

Reducing Early Readmission to an Acute Psychiatric Unit

Early readmission to psychiatric units poses a significant challenge for both patients with mental health issues and healthcare institutions. It hampers patient progress and prognosis, and the professional approach taken during discharge can greatly influence the recovery process. This paper proposes a multicomponent discharge transition intervention to mitigate the risk of early readmission to a Mental Health Hospitalization Unit (MHHU). The intervention entails developing a measurement scale to assess patients' risk of early readmission, allowing for stratification into high, medium, and low-risk categories. Tailored intervention strategies will focus on ensuring adherence and continuity of care post-discharge, with a more comprehensive approach for high-risk patients. Additionally, a post-discharge psychotherapeutic group will be incorporated for high-risk cases to support recovery. The efficacy of the program will be analyzed by comparing the overall early readmission risk at the Regional Hospital of Malaga's MHHU with the previous year, using admission episodes from two other hospitals in the province as a control group where the intervention program is not implemented. The success of the post-discharge group psychotherapeutic intervention will be evaluated through pre-post assessments of recovery measures, functionality, subjective well-being, social support, and treatment satisfaction. This proposal aims to address the issue of early readmission to psychiatric units by enhancing predictability and understanding of intervention strategies to reduce readmission rates.