Clinical Research Directory

Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression

SHAKTI (from the Sanskrit word for "power") is a 5-year natural history, longitudinal, prospective study of a cohort of 6,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to antidepressant treatment response (remission, recurrence, relapse and individual outcomes in depressive disorders) and resilience. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters - socio-demographic (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of developing the most robust predictive models of depression treatment response and of outcomes.

AI-Enabled Smartwatch for Medication Adherence in Outpatient Psychiatry

Medication nonadherence remains difficult to measure objectively in psychiatric care. This completed, single-center exploratory randomized trial evaluated whether four weeks of AI-enabled smartwatch medication monitoring improved clinician-rated medication adherence compared with waitlist usual care in psychiatric outpatients aged 12 years or older, predominantly adolescents and young adults with mood disorders.

Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children

The proposed study aims to begin the multi-step process of establishing the reliability and validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. The distribution of HTGC and carotid IMT-proximate indicators of cardiometabolic risk-across a range of dual-energy X-ray absorptiometry (DEXA)-measured adiposity in children treated with antipsychotic agents will be characterized in comparison to healthy, untreated, non-psychiatric controls, in order to estimate effect sizes for future studies incorporating these markers. The ability of HTGC and IMT to predict cardiometabolic risk as measured by commonly-used laboratory tests, such as fasting lipids, liver function tests, C-reactive protein and serum fibrinogen, will be assessed.

Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. The investigators have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.

Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of ASD Youth

This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive effects on ASD youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durability, dose and sub-population effects of the intervention.

The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study

A study in Finland found that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. The SINGER study is a 2-year randomized controlled trial that aims to test the efficacy and safety of these lifestyle changes, including diet and cardiovascular risk factor management, cognitive and physical exercises, in delaying cognitive decline in older adults at risk of dementia.

Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention

This study will evaluate whether Narrative Enhancement and Cognitive Therapy (NECT) can promote recovery among adults living with severe mental health disorders, including substance use disorders. NECT is a structured group intervention that combines education about stigma, cognitive techniques to challenge internalized negative beliefs, and narrative exercises that help participants develop a broader identity beyond their diagnosis. Approximately 106 adults receiving outpatient or day-hospital psychiatric care at Geneva University Hospitals will be randomly assigned to receive either usual care plus 12 weekly NECT sessions or usual care plus 12 comparison group sessions that do not specifically address self-stigma or recovery. The study will examine whether NECT improves recovery after the intervention and whether any benefits are maintained over time.

Reducing Stigma Among Healthcare Providers to Improve Mental Health Services

A growing number of trials have demonstrated treatment effectiveness for people with mental illness (PWMI) by non-specialist providers, such as primary care and community health workers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against PWMI. Therefore, interventions are needed to address attitudes among non-specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE-mh), is an intervention for non-specialists in which social contact with PWMI is added to training and supervision programs. A pilot cluster randomized control trial will address primary objectives including trainees' perspectives on perceived acceptability of PWMI's participation in training and supervision, intervention fidelity and contagion, assessment of randomization, and feasibility and psychometric properties of outcome measures in a cluster design. Secondary objectives are change in provider and patient outcomes. The control condition is existing mental health training and supervision for non-specialists delivered through the Programme for Improving Mental Healthcare (PRIME), which includes the mental health Global Action Programme (mhGAP) and psychosocial treatments. The intervention condition will incorporate social contact with PWMI into existing PRIME training and supervision. Participants in the pilot will be the direct beneficiaries of training and supervision (i.e., primary care workers) and indirect beneficiaries (i.e., their patients). Primary care workers' outcomes include knowledge (mhGAP knowledge scale), explicit attitudes (mhGAP attitudes and social distance scales), implicit attitudes (Implicit Association Test), and clinical competence (Enhancing Assessment of Common Therapeutic factors, ENACT) to be assessed pre-training, post-training, and at 4-month follow-up. Patient outcomes include functioning, stigma experiences in accessing care, and depression/alcohol use symptoms to be assessed at initiation of mental health care and 6 months later. The pilot study will assist in modifying the intervention to inform a larger effectiveness trial of RESHAPE to ultimately improve provider attitudes and clinical competence as a mechanism to improve patient outcomes.

Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia

Schizophrenia is a severe mental illness that seriously affects the health and functioning of patients. Previous studies have found immunoinflammatory abnormalities in the blood, cerebrospinal fluid, central nervous system, and neuroimaging of people with schizophrenia, along with therapeutic effects of anti-inflammatory drugs on schizophrenia. These evidences suggest a close relationship between schizophrenia and immunity and inflammation. Therefore, we consider that the state of immune inflammation is a potential subtype classification basis for schizophrenia, and hypothesize that immune classification based on peripheral-central multidimensional data is related to patient's response to medication and cognition.

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression

Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD. Objective: To test a study drug (HNK) in people with MDD. Eligibility: People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254. Design: Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity. HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule: They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study. They will receive no drugs for 2 to 3 weeks. They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study. One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo. ...

Stimulation-Induced Changes in Fronto-Limbic Network

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Implementation of REFOCUS Training Program in Mental Health Services

Training of mental health service teams in the orientation of care towards recovery through a 3-day training course: REFOCUS. This training aims to orient care towards recovery. Following this training, evaluation of the effectiveness of the implementation of REFOCUS training in mental health services.

Experimental Evidence of the Impact of Parental Income on Child Mental Health and Neuroimmune Function

Growing up in a lower-income family robustly predicts worse mental health in adolescence and early adulthood. How does variability in family income "get under the skin" of the developing child and via what mechanisms does it increase risk for mental illness? Moreover, could supplements to family income at critical developmental periods help to prevent later youth mental illness? To address these questions, we leverage an innovative existing double blind randomized controlled trial of 3-years of substantial income supplements to parents. By experimentally studying the impacts of these income supplements on families and subsequent youth development, we can examine causal pathways from family income to risk for mental illness via family stress and neuroimmune mechanisms in ways never done before. Moreover, by measuring the longer-term impact of 3 years of income supplements to parents on their child's neuroimmune signaling and risk for mental illness, we can examine the policy implications for child development of unconditional cash transfers to parents and identify how and for whom these supplements help. We will test these basic and translational questions in a sample of 1,200 youth with lower-income parents randomly assigned to receive either a substantial monthly income supplement or a minimal monthly supplement for 3 years, starting when youth were between age 5 - 14 years old. We will follow up with youth and their parent 1 - 2 and 3 - 4 years after the intervention and examine whether income supplements predict better youth mental health during adolescence, as well as whether factors like child age and neighborhood quality modulate intervention effects. Additionally, we explore family stress mechanisms through which the intervention may impact child mental health. Finally, we will measure peripheral inflammation (inflammatory biomarkers and classical monocytes) and use MRI to assess threat, reward, and regulatory neural activity and connectivity among 500 of these youth. Our central hypothesis is that income supplements will decrease family and youth stress and improve parenting, which will improve neuroimmune signaling and decrease risk for psychopathology. Moreover, these effects will remain years after termination of the transfers and be strongest among families who received the intervention earlier in the child's life. This research will provide timely, relevant public health knowledge that will help policy makers understand the longer-term brain, immune, and mental health impacts of cash transfers to parents, while also advancing the science of the sociocontextual and neuroimmune pathways through which variability in family income impacts risk for psychopathology.

Effects of ACT-Based Psychoeducation on Caregivers of Individuals With Mental Disorders

This randomized controlled trial aimed to examine the effects of Acceptance and Commitment Therapy (ACT)-based psychoeducation program on psychological resilience, stress management, and caregiver burden in caregivers of individuals with mental disorders. Participants were randomly assigned to either the intervention or control group. The intervention group received ACT-based psychoeducation while the control group received no intervention. H1-1: The mean psychological resilience scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group. H1-2: The mean stress management scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group. H1-3: The mean caregiver burden scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly lower compared to caregivers in the control group. H1-4: The effects of the ACT-based psychoeducation program on psychological resilience, stress management, and caregiver burden differ significantly between caregivers of individuals diagnosed with schizophrenia and caregivers of individuals diagnosed with bipolar disorder.

Exergames in Mental Health

Mental health and stress-related disorders have a growing impact on physical functioning, motivation, and participation in daily activities. Several studies indicate that integrating physical therapy into mental health programs improves functional status, reduces associated physical symptoms (fatigue, muscle tension, somatization), and promotes emotional regulation through movement. However, its implementation in clinical services remains limited. This project proposes to evaluate the effectiveness of an innovative mental health-oriented physical therapy program using active video games (exergames) on the Nintendo Switch platform, an accessible, motivating tool that can be adapted to each patient's functional level. Objective: To determine whether a structured physiotherapy program based on exergames promotes physical exercise, improves quality of life, and increases therapeutic adherence in patients with mental illness. Methods: An experimental pilot study will be conducted, implementing an intervention over 4 weeks, with 2 sessions per week lasting 40 minutes. Participants (n=12) will be assigned to an intervention group (exergames with Nintendo Switch) or a control group (usual routine). Quality of life, motivation, and therapeutic adherence will be assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire, the Intrinsic Motivation Inventory, and a satisfaction questionnaire. Expected results: The intervention group is expected to show better quality of life, greater motivation to exercise, and greater adherence to treatment. It is also expected to demonstrate that exergames are a viable tool, accepted by patients and incorporable into mental health physical therapy programs.

Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa

The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using wearable brain imaging, functional near-infrared spectroscopy (fNIRS), together with a brain-based 4-week text-messaging intervention. The investigators will examine how these interventions may influence inhibitory control and eating disorder symptoms in women with bulimia nervosa.

Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

Developing and Evaluating a Machine-Learning Opioid Overdose Prediction & Risk-Stratification Tool in Primary Care

This clinical trial aims to evaluate the pilot implementation of a machine-learning (ML)-driven clinical decision support (CDS) tool designed to predict opioid overdose risk within the electronic health record (EHR) system at UF Health Internal Medicine and Family Medicine clinics in Gainesville, Florida. The study will use a pre- versus post-implementation design to compare outcomes within clinics, focusing on measures such as naloxone prescribing rates and opioid overdose occurrences. Researchers will also assess the usability, acceptability, and feasibility of the CDS tool through qualitative interviews with primary care clinicians (PCPs) in the participating clinics.

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are: * Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care? * Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress. Participants will: * Receive standard nicotine replacement therapy (NRT) as prescribed by their physician. * Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points. * Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks. * Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.

Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)

Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. To address MHA system gaps, this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for at-risk youth with MHA challenges. In partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to MHA services. This model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services geared to need in a youth-friendly environment is expected to result in better MHA outcomes for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.

Psychiatric Multi-omics and Neuroimaging Project

This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.

Pharmacist-led Interventions in Psychiatric Patients

The goal of this intervention study is to examine the impact of pharmacist-led interventions in psychiatric patients initiating second-generation antipsychotic treatment. The primary purpose is to assess the impact of intervention on antipsychotic induced metabolic outcomes, such as weight gain and other cardiometabolic risk markers, in patients aged 18 to 60 years who have been diagnosed with chronic mental disorder. Participants will be assigned to either the intervention or the control group. The intervention group will receive educational interventions from the pharmacist at baseline, after 4 weeks, 8 weeks, and 12 weeks along with the standard therapy prescribed by the psychiatrist. On the other hand, the control group will receive only the standard therapy with no intervention from the pharmacist.