Treatment Trials

1,143 Clinical Trials for Various Conditions

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COMPLETED
BTL-699-2 for Improvement of Mental Well-being
Description

The goal of this clinical trial is to evaluate if the treatment with BTL-699-2 device is able to improve mental well-being in adults above the age of 22 years. The main question it aims to answer is: Does the treatment with BTL-699-2 device improve mental well-being? Participants will be asked to: * Undergo four treatments * Complete the Warwick Edinburgh Mental Well-being Scale * Complete the Therapy Comfort Questionnaire * Complete the Subject Satisfaction \& Mental Wellness Questionnaire

ENROLLING_BY_INVITATION
Elomia - Digital Mental Health and Well-Being
Description

This study is testing the acceptability and efficacy of an AI enabled mental health chatbot (Elomia) as a resource of college student wellness.

RECRUITING
Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention
Description

We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.

RECRUITING
A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Description

The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.

COMPLETED
Examining the Efficacy of a Single Session Online Mental Health Program
Description

There is a large body of evidence demonstrating that Acceptance and Commitment Therapy (ACT) can be delivered in a self-guided format to improve mental health among college students. However, previous research indicates there are challenges in engaging students in adhering to these time intensive, multi-session self-guided resources. Brief self-guided single session interventions could provide an accessible and acceptable intervention that is easier to adhere to, given their lower intensity and response effort for participation. This proposed study seeks to evaluate a single session online ACT Guide Lite intervention in a sample (n = 100) of Utah State University (USU) college students 18 years of age or older. A randomized controlled trial (RCT) design will be used in which students are randomized to receive ACT Guide Lite or to a waitlist condition in order to test the following predictions: (1) participants assigned to ACT Guide Lite will improve more on the primary therapeutic process of change, psychological flexibility, relative to those not receiving intervention, (2) participants assigned to ACT Guide Lite will improve more on distress, well-being, and interest in seeking help, relative to those not receiving intervention, (3) ACT Guide Lite will be acceptable to college students as indicated by recruitment rates, rates of completing ACT Guide Lite, and self-reported program satisfaction, and (4) areas for future program revisions will also be identified through participants' written feedback on their experiences using the program. USU students will be recruited to participate in the study through the SONA research platform in the Fall 2023 semester. All study procedures will be completed through the secure Qualtrics online research platform, in addition to email and phone contacts prompting relevant steps for the study. All analyses will be run with multilevel modeling with the full intent-to-treat sample to test time by condition interactions.

ACTIVE_NOT_RECRUITING
Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being
Description

The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.

RECRUITING
Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
Description

Despite advances in effective psoriatic disease treatment, the disease still has a serious impact on mental health and well-being of millions of patients. Up to 20.7% of patients report poor mental health, compared to 7.1% of the general population. Mental health treatment involves a combination of medication and talk therapy to address such issues. However, there is increasing evidence that optimizing behaviors such as sleep, physical activity, stress, and nutrition are critical components in improving mental health too. Numerous online health programs have evolved to help patients optimize such behaviors but very little exists for patients with psoriatic diseases. The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost, high-touch, personalized intervention that patients can access 24/7. In conjunction with traditional clinical care, the goal of this program is to leverage the convenience, affordability, scalability and effectiveness of an online eCoaching program to improve key physical behaviors, thereby reducing the mental health burden experienced by psoriatic disease patients.

COMPLETED
A Scalable Model for Promoting Functioning and Well-Being Among Veterans With a History of Mental Health Challenges Via Meaningful Social Interactions: Project V-SPEAK!
Description

The goal of this study is to refine and test a strategy for engaging veterans with symptoms of depression and/or anxiety as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

COMPLETED
Improving the Mental Health and Well Being of Healthcare Providers Through the Transcendental Meditation Technique
Description

The level of stress-related disorders experienced by Healthcare Providers (HCPs) has increased due to the recent COVID-19 Pandemic, impacting patient care and provider shortages. This trial aims to evaluate the use of the Transcendental Meditation Technique in improving burnout and wellbeing of HCPs over a 3-month trial period. A total of 130 HCPs will be recruited from participating Miami hospitals, with 65 HCPs receiving training in the use of the Transcendental Meditation Technique. The remaining participants will be part of a matched control group and will not receive any training. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months.

COMPLETED
Compassion Training and Mindfulness Training for Social Well-Being and Mental Health
Description

Study Design, Aims, and Population: The present study is a three-arm randomized controlled trial (RCT). The primary aim is to test the relative efficacy of two 8-week online interventions - Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) - in promoting diverse university students' social well-being (i.e., reduced loneliness, and enhanced social connectedness and perceived social support) compared to a Waitlist (WL) control group. The secondary aim is to examine the effects of CCT versus MBSR on the mental health of diverse university students compared to the WL group. Mental health is defined in this research as both positive mental health (i.e., happiness, positive emotions, meaning and purpose) and negative mental health (i.e., stress, anxiety, and depression). Additionally, another aim is to enroll 75% students of color and 50% male identifying students, whose social well-being and mental health is currently understudied, to better represent the sociodemographic diversity of the university student population in the literature. Study Rationale: The COVID-19 pandemic triggered widespread disruptions in social connections and relational bonds that robustly support a variety of mental and physical health-protective processes. University students' social well-being may have been especially impacted as universities provide a central context for socialization. At the same time, the pandemic exacerbated a pre-existing rise in cases of mental health conditions in university students. If found effective, online-based CCT and MBSR might serve as scalable psychological interventions to foster social thriving and mental health among diverse university students.

COMPLETED
Health Care Workers and Mental Health
Description

The purpose of this proposal is to deploy digital health interventions to bring timely, easily accessible resources and care to address the mental health and well-being needs of HCWs with direct patient care that are experiencing the impact of the COVID-19 pandemic and its economic, financial, and social sequelae at present and presumably for years to come. This proposal will evaluate the effectiveness of an enhanced digital mental health care delivery system (Cobalt), any differential effect by race and gender and, through qualitative interviews, how those interventions are perceived.

COMPLETED
Effect of the COVID-19 Public Health Crisis on the Mental Health and Physical Well-Being of Cancer Patients, the Coping With COVID Study
Description

This study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. Questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.

COMPLETED
A Smartphone Intervention for Relational and Mental Well Being
Description

The primary aim of this study is to provide and evaluate a phone-based intervention to improve relational and mental well-being during the COVID-19 crisis. This information also will help us understand how individuals are responding to COVID-19 and have the potential to inform psychological and policy level interventions.

COMPLETED
Immigrant Well-being Project: Transdisciplinary Ecological Mental Health Intervention for Mexican Immigrants
Description

The goal of this study is to test a transdisciplinary ecological approach to reducing mental health disparities among Mexican immigrants by adapting and integrating a multilevel community-based advocacy, learning, and social support intervention (Immigrant Well-being Project, IWP) into existing efforts at three community partner organizations that focus on mental health, education, legal, and civil rights issues for Mexican immigrants. This research is innovative and significant because it employs cutting edge strategies to address social-structural determinants of mental health and examines the community-engaged process of adapting and testing the impact of a multilevel intervention originally designed for refugees. The IWP intervention emphasizes a sustainable and replicable partnership model between community-based organizations and universities that involves Mexican immigrants and undergraduate advocates working together to: a) increase immigrants' abilities to navigate their communities; b) improve immigrants' access to community resources; c) enhance meaningful social roles by valuing immigrants' culture, experiences, and knowledge; d) reduce immigrants' social isolation; and e) increase communities' responsiveness to immigrants through changes in policy and practice. The IWP is administered by university students enrolled in a service learning course, and has two elements: 1) Learning Circles, which involve cultural exchange and one-on-one learning opportunities, and; 2) Advocacy, which involves collaborative efforts to mobilize community resources related to health, housing, employment, education, and legal issues. Studies of the intervention model with refugees demonstrated feasibility, appropriateness, acceptability, and evidence that the intervention decreased participants' psychological distress and increased protective factors, and impacted changes in system-wide policies and practices. After completing in-depth ethnographic interviews with 24 Mexican immigrant adults to elucidate their mental health needs, stressors, current political/economic/social context, and local solutions, and a process of community engagement and intervention adaptation, a mixed methods strategy with data collected from 90 participants at four time points over a period of 14 months will be used to test the impact of the 6-month intervention on reducing psychological distress, increasing protective factors (access to resources, English proficiency, environmental mastery, and social support), and achieving system-level changes in organizational, local, and state policies and practices that impact Mexican immigrants' well-being. Mechanisms of intervention effectiveness will be explored by testing mediating relationships between protective factors and psychological distress. Qualitative data will explore feasibility and acceptability of the intervention, participants' experiences in the intervention, and unexpected impacts; document multilevel changes and the context of implementation at each site; and inform interpretation of quantitative data. Quantitative and qualitative data on the quality of the CBPR partnerships and their relationship to multilevel outcomes will also be examined.

Conditions
COMPLETED
Improving Mental Health and Well-Being Via Awe Walks
Description

Awe is a powerful positive emotion that offsets negative emotion and fosters prosocial behavior. This study examined the effects of awe on health and well-being in healthy older adults. Half of the participants took a weekly "awe walk" while the other half took a weekly walk with no further instructions.

COMPLETED
Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being
Description

The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.

Conditions
NOT_YET_RECRUITING
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Description

The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.

NOT_YET_RECRUITING
Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
Description

The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.

RECRUITING
Retrospective Analyses of the Greenbrook Database Evaluating Mental Health Treatments
Description

The study involves multiple retrospective analyses to understand the utilization of mental health treatments provided at Greenbrook and their effectiveness

ACTIVE_NOT_RECRUITING
Effectiveness of the Adapt for Life, Mental Wellness and Suicide Prevention Program
Description

Adapt for Life is a mental health and wellbeing program designed to help young people develop healthy behaviors and important life skills to manage stress and mental health challenges. The program is a collaboration between Adapt for Life and Cincinnati Children's Hospital Medical Center. Purpose of the Study: The primary purpose of the Adapt for Life study is to evaluate the effectiveness of the ADAPT framework in improving mental health outcomes for students. The framework includes steps such as Ask, Describe, Assess, Plan, and Talk, which are designed to help students tackle stress during everyday moments or in times of crisis. Question the Study is Trying to Answer: The study seeks to answer whether the ADAPT framework can significantly improve students' ability to manage stress, recognize mental health issues, and seek appropriate help. It aims to determine if the program can reduce instances of harmful behaviors and improve overall mental wellbeing among participants.

NOT_YET_RECRUITING
Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention for Middle-Aged and Older Adults With Chronic Pain
Description

The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and/or anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio/video recorded call. Participating in the interview portion is optional.

NOT_YET_RECRUITING
Weyera Mental Health Pilot Intervention
Description

This study aims to pilot a group-level intervention focused on mental health and resilience among Ethiopian and Eritrean youth. The study follows previous work that showed high rates of mental health outcomes (depression, anxiety, post-traumatic stress disorder (PTSD)) among Ethiopian and Eritrean youth in Atlanta. The goal is to determine the acceptability, feasibility, and safety of this culturally relevant group-level intervention before a larger trial to improve resilience processes that support mental wellness in a community-based setting.

RECRUITING
Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho
Description

Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression. As many as 70% of mothers of preterm infants experience postpartum depression compared to only 12.5% of those delivering full-term infants. Increased stress and depression during this critical period are detrimental because they hamper a mother's ability to care for her infant and are associated with increased neonatal sepsis and mortality, decreased neonatal growth, and delayed motor and cognitive development. Postpartum depression is also associated with excessive maternal weight gain and risk for metabolic diseases, anxiety, and sleep disturbances. Stress in breastfeeding mothers can also alter circulating concentrations of some bioactive components (e.g., immunoglobulins, cortisol) that can transfer into milk. As such, understanding factors predisposing these vulnerable women to extreme levels of stress and finding ways to lower this stress and lessen its negative health outcomes on mothers and infants are important public health challenges. The March of Dimes estimates that 8.5% of births in Idaho are preterm, making this topic particularly relevant for Idaho women. Risk factors for postpartum depression in mothers delivering term or preterm infants are complex, but maternal nutrient deficiencies may be involved. Vitamin D status, for instance, is inversely correlated with risk of postpartum depression in women delivering term infants. However, vitamin D interventions have yielded inconsistent results, perhaps due to confounding impacts of geographic location, skin color, and endogenous vitamin D synthesis. Endogenous vitamin D synthesis requires cutaneous sunlight exposure, placing Idaho women at even greater risk of vitamin D deficiency - particularly in the winter when days are extremely short (only 7 hr on the winter solstice). The impact of maternal vitamin D supplementation during lactation on infant variables (e.g., vitamin D status) has been examined. However, its effect on maternal mental health has not been rigorously studied - let alone in the 'frontier and remote' (FAR) rural West, including Idaho, with short periods of wintertime sunlight and poor access to healthcare. Our long term goal is to develop interventions to improve maternal and infant health in Idaho - particularly in the context of preterm births. The overall primary objective of this proposal is to determine if maternal vitamin D supplementation improves vitamin D status and mental health in Idahoan mothers of preterm infants. Our central hypothesis is that vitamin D supplementation improves vitamin D status and reduces stress and other indicators of poor postpartum maternal mental health in Idaho women delivering preterm infants. Secondarily, we will assess the effects of maternal vitamin D supplementation on human milk composition.

Conditions
RECRUITING
Recovery Finance: Financial Health and Mental Health After Incarceration
Description

This proposal will address financial wellbeing, an often overlooked but important factor impacting reentry for justice-involved people with mental health challenges, who are disproportionately Black and Latine. The project will change community level determinants by integrating financial capability support (one-on-one coaching and access to financial tools and services) into existing services and training bank and credit union staff to reduce discrimination. It will also support collaborative community efforts working towards upstream policy and legal reforms to reduce the incidence of those financial challenges.

NOT_YET_RECRUITING
Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health
Description

The goal of this clinical trial is to learn if the Social-emotional Skills for Thriving and Relating at School (SSTRS) Program can help children entering kindergarten and their families. The main questions it aims to answer are: 1) Do children who participate in SSTRS have better social-emotional skills and mental health? and 2) Do parents who participate in SSTRS have more positive parenting skills and involvement in their children's learning? Researchers will compare the SSTRS Program to the regular kindergarten curriculum without SSTRS to see if being in SSTRS helps children to have better mental health and parents to have better parenting skills. Kindergarteners will have daily SSTRS lessons in their kindergarten classes for 8 weeks. Their parents will watch videos and attend group meetings with other parents and answer questions about their own and their children's behaviors and mental health

NOT_YET_RECRUITING
Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients
Description

The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are: Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine. Participants will: Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls

ENROLLING_BY_INVITATION
Train and EMPOWER a Community Health Workforce to Achieve Equity and Reduce Disparities in Mental Health
Description

The investigators suggest a multi-step approach to improve access to mental health care for minority groups. The plan focuses on three goals: increasing diversity in the mental health workforce, bringing more expertise into the community, and strengthening the community's ability to address the factors that impact mental health. To do this, the TEACH study team will work with students from underrepresented racial and ethnic groups at a minority-serving school. Students will be provided the opportunity to obtain their CHW Certification while receiving course credit for their degree. Students will then be eligible to participate in an internship to utilize their skills. The TEACH study team will help these students with their training, supervision, and ongoing support. These students will then be able to work with their communities to tackle common mental health issues and the social factors that contribute to those problems.

ENROLLING_BY_INVITATION
COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
Description

This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.

Conditions
COMPLETED
Exercise and Endocannabinoids for Brain and Mental Health
Description

This study will explore how exercise affects brain chemicals called endocannabinoids, which may improve thinking skills and reduce feelings of stress, anxiety, and low mood in children and teens aged 9 to 17. Participants will take part in a single 30-minute activity session, where they will be randomly assigned to one of three groups: 1. Moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate). 2. Light stretching (gentle movements at less than 40% of their maximum heart rate). 3. Seated meditation (relaxing without movement at less than 30% of their maximum heart rate). The investigators will measure endocannabinoid levels, thinking skills, and mood before and after the activity to see how these activities affect the brain and emotions.

RECRUITING
Peer to Peer (P2P): Mental Health Interventions with Persons with Substance Use Disorders
Description

This study provides substance use and mental health peer support services to address behavioral health disparities in rural areas. Specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for patients working towards long-term recovery from co-occurring mental health and substance use disorders. Participants will be assessed and evaluated for opioid use disorder (OUD), social determinants of health (SDoH), and infectious diseases by a nurse practitioner and a social worker. A certified peer support specialist (CPSS) will provide additional support, connecting patients to sustainable mental health resources and implementing a modified version of the Friendship Bench intervention, which involves six weekly 45-minute problem-solving therapy sessions with the option to participate in six or more peer support sessions. The CPSS will follow the patient for up to 12 weeks.