Mental Health clinical trials at University of California Health
24 in progress, 14 open to eligible people
Black Economic Equity Movement
open to eligible people ages 18-24
The primary goal is to understand the potential impacts of Guaranteed Income (GI) on Black youth and young adults' financial, emotional, and physical well-being. The main question it aims to answer is: What are the impacts of GI on Black young adults' investments in their future, mental health and unmet mental and sexual/reproductive health service needs? Participants will receive guaranteed income for 12 months and will be offered enrollment in financial capability programs.
at UCSF
Emotion-Diet Interactions in Pregnancy
open to eligible females ages 18-40
This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared to a less healthy meal (high GI).
at UC Irvine
Examine the Effects of Mindfulness in Woman With a History of Child Adversity
open to eligible females ages 30-50
The aim of this pilot Randomized Controlled Trial (RCT) is to test whether brief mindfulness-based practices will improve well-being and health in women (age 30-50) with a history of early life adversity. Following a baseline visit (remotely via Zoom), participants are randomized (50% probability) to either a Mindful Activity group or a Mindful Awareness group. In the Mindful Activity group, participants will complete brief (approximately 5-10 min) audio-guided mindfulness practices twice a day (morning and evening) for 8 weeks using the study app. This is followed by a brief survey about their current thoughts and feelings. In the Mindful Awareness group, participants are asked to be mindful (pay attention) to their thoughts and feelings twice a day (morning and evening) for 8 weeks using the study app. After the 8-week intervention period, all participants complete a follow-up visit (remotely). Primary goals of the pilot RCT are to test acceptability, feasibility, and adherence.
at UCSF
Family Mental Health Family Navigator Project (FMHN)
open to eligible people ages 6-17
This study will focus on developing and testing a family-based mental health navigator intervention, the Family Mental Health Navigator (FMHN), to evaluate whether the intervention combined with mHealth is preliminary efficacious in improving mental health service initiation and engagement for publicly-insured youth.
at UCSF
Foster Care Mental Health Family Navigator
open to eligible people ages 12-17
This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.
at UCSF
Healing Experiences of Adversity Among Latinos (HEALthy4You)
open to eligible people ages 5-11
Healing Experiences of Adversity Among Latinos (HEALthy4You) is a project funded by the California Initiative for the Advancement of Precision Medicine ("Advancing a Precision Population Health Approach to ACEs to Reduce Health Disparities"). The long-term goal of this project is to develop community-centered, culturally Appropriate, precision Interventions that can be delivered within Federally Qualified Healthcare Centers (FQHCs) for Latino Families, to reduce Adverse Child Events (ACES) risks and treat childhood obesity. UCSD in conjunction with Family Health Centers of San Diego (FHCSD) will conduct a 2x2 factorial trial with four groups meant to determine what combination of intervention components influence family protective factors (a key marker for reduced risk of the deleterious effects of systemic and family/individual stressors that are a critical part of ACEs) and childhood obesity.
at UCSD
Healthcare Providers as Trusted Messengers to Increase Receipt of Tax Credits Among Low-income Families
open to eligible people ages 18-99
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of healthcare provider referrals to a tax filing app within parent-child health programs to test whether such referrals can increase receipt of tax credits among low-income parents. The study will use a single-group, pre/post test design with a sample of approximately 100 women who have a child under 6 years of age. Participants will be recruited from parental-child health programs and clinics in Los Angeles and will complete surveys at baseline, immediately after tax filing season, and six months after tax filing season to assess 1) frequency of tax filing after referral (Feasibility), 2) the acceptability of the tax filing app from the perspective of users (Acceptability), and 3) pre/posttest changes to parent and child health, child development, and healthcare utilization measures for users (preliminary efficacy).
at UCLA
Intergenerational Transmission of Traumatic Stress
open to eligible people ages 3 years and up
Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.
at UCLA
Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
open to eligible people ages 40 years and up
Caregivers suffer great amounts of distress that significantly impacts their mental and physical well-being, yet caregivers' access to quality, evidence-based care is currently very limited. The public health significance of the proposed study is that our internet and mobile-based web intervention will (1) significantly reduce caregiver distress and improve caregivers' overall well-being, and (2) dramatically increase caregivers' access to high quality, evidence-based care at relatively low cost.
at UCSD
Parenting Stress mHealth
open to eligible people ages 12 years and up
Parenting stress is a well-documented barrier to youth engagement in community-based substance use treatment. The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth, a population with high rates of substance use and low rates of treatment engagement.
at UCSF
Race-Based Stress Trauma and Empowerment
open to eligible people ages 18 years and up
The existence of racially/ethnically based health disparities is well established, both within the civilian community and among Service Members and Veterans. Experiences of discrimination are acute and chronic stressors that substantially contribute to greater emotional distress, poorer health behavior, lower healthcare utilization and increased allostatic load, all of which undermine well-being, functioning and Whole Health. An innovative clinical program, the Race-Based Stress/Trauma and Empowerment (RBSTE) group, was developed to help Veterans of Color to build coping resources and empowerment. Although qualitative data suggest the promise of this intervention, systematic evaluation is lacking. The proposed feasibility project will lay the groundwork for a future randomized controlled trial to evaluate RBSTE as compared to a control group in terms of Whole Health, functioning and mental/physical wellness. The project thus begins a program of research to address the health implications of systemic racism.
at UCSD
SSIs for Mental Health and Loneliness
open to eligible people ages 16 years and up
This project includes three studies that explore the effectiveness of brief internet interventions for mental health and loneliness. Study 1: The goal of this clinical trial is to examine if a brief online single-session intervention (SSI) adapted from an evidence-based internet cognitive behavioral therapy can reduce feelings of loneliness in people aged 16 and older who struggle with loneliness. The main question it aims to answer is if a brief SSI is sufficient to meaningfully reduce loneliness compared to an active control. Researchers will test these questions by comparing change in loneliness after 8 weeks between participants randomly assigned to either 1) a 30-minute online SSI for loneliness or 2) a 3-session online intervention for loneliness or 3) an active control SSI. Study 2: The goal of this clinical trial is to examine if an SSI for psychological distress that uses popular online content as its primary form of intervention content can reduce feelings of psychological distress in people aged 16 and older who struggle with psychological distress. The main questions it aims to answer are 1) if curated popular online content can be more effective in supporting people struggling with psychological distress than researcher-created content and 2) if curated popular online content can be more effective in supporting people struggling with psychological distress than un-curated self-selected popular online content. Researchers will test these questions by comparing change in distress after 8 weeks between participants randomly assigned to either 1) 25-minute popular online content-based SSI for distress or 2) an effective 25-minute online SSI for distress with evidence-based researcher-created content or 3) online help-seeking as usual. Study 3: The goal of this clinical trial is to examine if an SSI for loneliness that uses popular online content as its primary form of intervention content can reduce feelings of loneliness in people aged 16 and older who struggle with loneliness. The main questions it aims to answer are 1) if curated popular online content can be more effective in supporting people struggling with loneliness than researcher-created content, 2) if curated popular online content can be more effective in supporting people struggling with psychological distress than an active control, and 3) replicating the comparison in study 1, if a brief SSI is sufficient to meaningfully reduce loneliness compared to an active control. The study will test these questions by comparing change in loneliness after 8 weeks between participants randomly assigned to either 1) a 25-minute popular online content-based SSI for loneliness or 2) a 25-minute online SSI for loneliness with evidence-based researcher-created content or 3) an active control SSI.
at UC Irvine
Discrimination and the Brain-Gut-Microbiome (BGM) Axis
open to eligible females ages 18-50
Obesity is a major public health problem related to a variety of illnesses such as heart disease and diabetes. Prior research indicates that social stressors contribute to risk for obesity, possibly through alterations in diet and physical activity. However, it is not fully clear how these alterations contribute to obesity. The purpose of this study is to examine how the stressors of social isolation and discrimination relate to eating behaviors and dietary patterns, and further, how these behaviors affect the brain-gut-microbiome (BGM) connections. This study will focus on Mexican and Filipina women because research shows that they encounter a high burden of obesity and exposure to social stressors. Approximately 300 Mexican and Filipina women will be screened and enrolled. They will then provide information about social stressors via food diaries, physical body measures (e.g. waist circumference), questionnaire data regarding diet and eating behaviors, and measures of physical activity. Stool and serum will be collected to analyze microbes and metabolomics, and MRI to assess brain changes in the reward network. Analytic techniques will be used to integrate data from these multiple data sources. This analysis will determine the unique differences associated with ethnicity and social stressors in moderating eating behaviors and dietary patterns. The results of this study will provide new information about a possible pathway whereby social stressors affect behavioral, neurological and microbiome mechanisms related to obesity risk and provide new information in BGM patterns in two understudied ethnic groups. In the long term, this research may suggest possible approaches for intervention that may help reduce inequalities in obesity and related health problems.
at UCLA
Ethnic Influences on Stress, Energy Balance and Obesity in Adolescents
open to eligible females ages 13-17
The study will examine the mechanisms linking race, stress and biobehavioral factors to energy balance and obesity in both natural and controlled environments in African-American and Caucasian adolescent females. A Hispanic/Latina cohort has recently been added with permission for the sponsor.
at UC Irvine
Adolescent Acts of Kindness Intervention With Reflection
Sorry, not yet accepting patients
Adolescents will complete a 4-week intervention, during which they will either complete a kind act for others, complete a kind act for others with a reflection component, or report their daily activities three days per week. Psychological measures will be indexed before and after the intervention.
at UCLA
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress
Sorry, in progress, not accepting new patients
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW). Considering POC exposed to race-related stress are at high risk of developing a mental health disorder, there is a clear need for treatments that allow individuals to cope effectively with these stressors. Among many evidence-based treatments available, mindfulness-based interventions (MBIs) may be particularly well suited to help POC cope. MBIs are hypothesized to be effective via increases in mindfulness and self-compassion, as well as reductions in experiential avoidance, rumination, and emotion suppression. Despite their effectiveness, MBIs rarely reach POC. As such, innovative strategies such as self-directed app-based intervention may reduce the treatment gap. Considering the lack of research examining the effectiveness of MBIs among POC, especially those who experience elevated levels of race-related stress, this study will employ a randomized control trial (RCT) approach to examine whether receiving an app-based MBI engages the hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression) among POC. Similarly, the study will test whether the intervention leads to decreases in the negative mental health outcomes more often associated with exposure to race-related stress (i.e., stress, anxiety, depression). Acceptability, adherence, and satisfaction also will be analyzed to explore whether a non-culturally adapted MBI is still relevant for POC who face race-related stress. Results from this trial will contribute to the nascent data on MBI acceptability and effectiveness with POC. To the investigators' knowledge, this study will also be the first to include a sample of POC recruited based on elevated levels of race-related stress, a high-risk population that is not commonly targeted in MBI research.
at UCLA
Feasibility Trial of a Lifestyle Intervention for CHR-P
Sorry, accepting new patients by invitation only
The present study will assess the feasibility and social validity of an adjunctive health promotion group for youth and clinical high risk for psychosis (CHR-P). Youth participating in treatment at the Center for the Assessment and Prevention of Prodromal Sates (CAPPS) will be invited to participate in a weekly, adjunctive, closed psychoeducation group focused on sharing health promotion strategies and increasing health behaviors (e.g. improved sleep habits, increased participation in physical activity). The aim of the group will be to provide psychoeducation on lifestyle risk and protective factors for youth at risk for psychosis (i.e. experiencing subthreshold psychosis symptoms). Topics covered will include psychoeducation, goal setting, stress management, sleep, physical activity, substance use, and nutrition. Evidence-based strategies to decrease risk factors and promote protective lifestyle factors for mental illness will be reviewed. Group leaders will utilize a motivational interviewing approach to facilitate the group. The group will complete nine weekly group sessions. The goal of our research is to 1) determine the feasibility of a novel group-based health promotion intervention, 2) assess the social validity of the group, 3) measure the effects of the intervention on stress, sleep, physical activity, substance use, and nutrition, and 4) measure preliminary effects on symptoms and functioning.
at UCLA
ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Sorry, accepting new patients by invitation only
This is an interventional research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.
at UCSF
Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
Sorry, accepting new patients by invitation only
This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.
at UCSD
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Sorry, not yet accepting patients
Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes
at UCLA
Rural Dementia Caregiver Project
Sorry, in progress, not accepting new patients
These caregivers are a vulnerable group due to their physical isolation and well-documented rural disparities in health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers. Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia. The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depression symptoms. The investigators hypothesize that stress scores and depression symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations. If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).
at UCSF
TEAMS R34 #1 After-Action Reviews in Child Welfare Services
Sorry, in progress, not accepting new patients
This project proposes to improve successful mental health service linkage in Child Welfare Services (CWS) by adapting and testing the After Action Review (AAR) team effectiveness intervention to augment the Child Family Team (CFT) services intervention. Despite being both required and a collaborative approach to service planning, CFT meetings are implemented with questionable fidelity and consistency, rarely including children and families as intended. By inclusion of child and family voice, the AAR-enhanced CFT should lead to increased fidelity to the CFT intervention and greater levels of parental satisfaction with the service and shared decision-making, thus resulting in enhanced follow-through with Action Plans and linkage to mental health care for children.
at UCSD
VR Mindfulness Study
Sorry, not yet accepting patients
This is an exploratory study investigating the use of virtual reality-based guided mindfulness meditation in improving pain, stress, and mood within various clinical populations. The feasibility of utilizing VR applications within the populations of patients with various specific disease types and clinical settings is a burgeoning area of research. The goal is to establish an association between the use of VR-based mindfulness meditation, and pain, stress, and mood scores.
at UCLA
Effectiveness of Supportive Housing on COVID-19 Related Outcomes for People Experiencing Homelessness
Sorry, in progress, not accepting new patients
This study aims to understand the comparative effectiveness of two PSH models (PB-PSH and SS-PSH) on quality of life and COVID-19 related health behaviors by following for 6 months a cohort of 800 PEH who have been placed in either PB (n=400) or SS (n=400). In a natural observational experiment, participants will complete 6 monthly mobile-based questionnaires exploring quality of life including physical, mental, social, and housing/environmental health, COVID-19 prevention practices (i.e., handwashing, social distancing, face covering), and past-30-day healthcare utilization. A sub-sample of 40 participants living in both PB-PSH and SS-PSH will be qualitatively interviewed longitudinally to help contextualize quantitative findings. Focus groups will also be conducted with providers of PSH and qualitative interviews will be conducted with other key stakeholders to understand perspectives on the challenges of implementing and sustaining COVID-19 related prevention practices while maintaining a continuity of care.
at UCLA
Our lead scientists for Mental Health research studies include Nastassia Hajal, PhD Karen Lindsay Johanna B Folk, PhD Sheri A Lippman, PhD Nicole Stadnick Stefanie E Mayer, PhD Brent T Mausbach, PhD Eric Hekler Uma Rao, MD Andrew J Fuligni, PhD Veronica Yank, MD Ariel J. Lang, PhD Marina Tolou-Shams, Ph.D Danielle Fettes Arpana Gupta, PhD.
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