Clinical Research Directory

Social Media Concerns Related to Emotional Experiences in Naturalistic Settings (SCREENS)

The objective of this study is to advance understanding of the relationships between social media use (SMU) and internalizing symptoms among a diverse sample of depressed and/or suicidal youth. Youth (ages 13-18) enrolled in the TX-YDSRN registry study will be recruited for participation in SCREENS. After reviewing the Information Sheet, participants will complete baseline measures assessing internalizing symptoms (e.g., depression, anxiety, suicidal ideation/behavior), and trauma history. They will then complete ecological momentary assessments (EMAs) twice daily for 30 days via the mHealth app, capturing internalizing symptoms, emotional responses to social media, and in-person social support. The mHealth app will also collect the amount of social media use during this 30-day period. From Month 1 through Month 6, participants will receive monthly self-report surveys administered through REDCap. 100 participants This study will enroll youth from the TX-YDSRN registry study who meet all the following criteria: * Be between 13 and 18 years of age at the time of enrollment. * Be currently enrolled in the TX-YDSRN registry study and willing to allow sharing of data from that study. * Own a smartphone and agree to download and use the study mHealth application for the duration of study participation. * Be willing and able to participate in all study requirements and allocate sufficient time to complete study questionnaires and measures. Visits include a Screening Visit, Baseline Visit, EMA 2x daily for 30 days, 6 remote follow-up survey visits. Multiple streams of outcome measures will be utilized for this protocol, including self-report measures, research assessor-completed measure, and EMA measures. Adverse event (AE) recording, 9 item Patient Health Questionnaire Adolescent Version (PHQ-A), Concise Health Risk Tracking Self Report (CHRT-SR).

The Relationship Between Internet-use Behavior and Mental Health in Youth

Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying. Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time. Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form.

Telehealth to Improve Quality of Life in Persons Living in Rural Texas

The overarching goal of this project is to evaluate a current evidence-based practice, Cognitive Behavioral Therapy, for mental health conditions against Cognitive Behavioral Therapy plus two check-in calls a week for adults living in rural Texas.

Psychobiological Interventions in Pregnancy

This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.

Community-Based Music Mindfulness Intervention on Children

The goal of this clinical trial is to learn how community-based music mindfulness interventions impact anxiety, depression, and overall emotional well-being in children and adolescents with attention-deficit/hyperactivity disorder and/or anxiety. The main questions it aims to answer are: * How do participants' psychological states change from the start to the end of the intervention? * What physiological changes, including heart rate variability and sleep patterns, are observed after the intervention? * Is this study feasible and acceptable to the community? Participants will: * Attend in-person sessions, bi-weekly for 8 weeks * Regularly complete psychometric assessments * Wear fitness trackers daily, including overnight, throughout the study period * Track self-guided intervention online * Participate in semi-structured interviews pre-/post-study

Telehealth to Reduce Mental Health in Family Caregivers

The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia when provided over telehealth.

Stress Phenotypes and Preterm Birth

Pregnancy ends in preterm birth (PTB) for approximately 1 in 10 women, though more often for Non-Hispanic Black women, 14.12% PTB rate, compared to 9.09% for Non-Hispanic White women. Psychosocial stress and childhood trauma each are associated with risk for PTB and PTB has an intergenerational impact: mothers born preterm are more likely to give birth preterm, especially amongst Black women. In this project, we will study mitochondria, which contain their own genome, the mitochondria DNA, and are inherited from the mother, as they represent a potential intersection point between psychosocial experiences and their biological embedding in underlying disease outcomes such as PTB

Intervention for Virologic Suppression in Youth

The goal of this randomized clinical trial is to test the effect of a technology-based intervention with an Adaptive Treatment Strategy (ATS) among youth living with HIV (YLWH) (18-29 years old). This piloted and protocolized intervention combines: (1) brief weekly sessions with a counselor via a video-chat platform (video-counseling) to discuss mental health (MH), substance use (SU), HIV care engagement, and other barriers to care; and (2) a mobile health application (app) to address barriers such as ART forgetfulness and social isolation. Individuals who are not virologically suppressed will be randomized to video-counseling+app or standard of care (SOC). Through this study, the investigators will be able to: Aim 1: Test the efficacy of video-counseling+app vs SOC on virologic suppression in YLWH.The investigators will compare HIV virologic suppression of those randomized to the intervention vs control arms at 16 weeks via an RCT. Aim 2: Assess the impact of video-counseling+app vs SOC on MH and SU in YLWH. The investigators will evaluate the MH and SU differences between the intervention vs control arms at 16 weeks via an RCT. Aim 3: Explore an ATS to individualize the intervention by assigning the: 1. virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks, 2. virologic "responders" in the intervention arm to continue only app use for 16 more weeks. Researchers will compare the characteristics of virologic responders and non-responders to the intervention, individualization of the intervention based on these variables, and linkage to MH and SU treatment services among those in need to see if delivery of care is enhanced and impact on virologic suppression.

The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People

In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Participants will be randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, including well-being (WHO5), psychological functioning (SWEMWBS), help-seeking intentions, and body appreciation (2-item BAS-2SF), will be measured at 2-, 6-, and 12-weeks post-randomization and analyzed using the intention-to-treat approach. Qualitative interviews with intervention group participants will provide complementary insights, and a cost-effectiveness analysis will also be conducted.

Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women

The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are: 1. Is the Down Dog prenatal yoga app feasible for AA pregnant women? 2. How does mental and physical health change after using the Down Dog app for 12-weeks? 3. What cultural adaptations to the Down Dog app are needed? The study lasts for 12 weeks and participants are asked to: * do prenatal yoga with the app for at least 20 min/day, three days/week, from home * wear a Garmin Vivosmart 5 watch daily * complete four online surveys * complete an optional virtual interview This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes.

Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors

Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills. Moreover, all of these interventions follow a "one size fits all" approach, lacking precision in terms of when, where, and to whom they should be given. The overarching goals of this project are to develop and pilot a variety of digital micro-interventions (DMIs) for breast cancer survivors - highly focused, technology-enabled interventions that can be delivered in the context of a person's daily life with little burden on the individual.

Tell Me More ("Dime Mas")

This study will be used to develop a program to help Latino men who have sex with men obtain pre-exposure prophylaxis (PrEP), HIV testing, and behavioral health services. The project will then involve a pilot test of this program with a community partner.

Just-in-Time Training for Youth Mentors

This study will evaluate the usability, feasibility, and acceptability of a novel multi-level Just-In-Time Training (JITT) implementation strategy (JITT-EBP) that aims to equip mentors and mentor supervisors to implement evidence-based practices (EBPs) with fidelity using methods that are sustainable in rural communities. JITT-EBP integrates (a) self-directed, on-demand, online training modules for mentors and mentor supervisors, (b) synchronous evidence-based supervision strategies, and (c) an apprenticeship delivery model in which EBPs are co-led by an experienced mentor and a novice mentor, providing opportunity for in-the-moment training and support. The study will conduct a pilot hybrid type 2 effectiveness-implementation trial to evaluate the use of JITT-EBP compared to usual training for implementing mentor-delivered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program. 96 adolescents (age 12-17) and their parents, 8-18 mentors (depending on amount of turnover), and 4 mentor supervisors will be enrolled in the trial.

Pathways to Improved Adolescent Mental Health in Conflict Affected Families

The study combined a youth-friendly economic empowerment program (Rabbits for Resilience (RFR) with a gender equality couple curriculum program (HIKA) to advance knowledge on the combined and synergistic impact of structural interventions and pathways with families for improved adolescent mental health in resource-poor communities. The investigators' multidisciplinary team will conduct a randomized controlled trial with three arms (RFR only, HIKA only, RFR + HIKA) with young adolescents ages 10-14 years and the adolescents' mothers and fathers living in 1080 rural households in 30 villages in two rural conflict-affected territories of South Kivu province of Eastern Democratic Republic of Congo (DRC)

Clinical Validation of Samsung Smartwatch

Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 135 individuals diagnosed with current Major Depressive Disorder and 85 healthy controls. To meet this target, the recruitment target is set at 220 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.

Sweet Scents to Sweet Dreams

The purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. The goal of this study is to improve sleep and quality of life using herbal and Ayurveda/holistic-based botanical pillows.

Impact of Multi-component Interventions on Populations With Mental Health Symptoms and High-risk COPD

Study Participants: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale \<45 . Intervention: We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring for population health. For study participants in the intervention arm, we will ask them to finish an online COPD-SQ questionnaire with notification of his or her COPD high risk status. For those with high-risk COPD population, we will provide face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For high-risk COPD population with mental health issues in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC\<0.7, they will be spirometry-defined COPD patients and will be encouraged to seek treatment and medication to the superior hospitals. A CBT-based digital health intervention program, EmoEase, will be provided to our study participants with an intelligent mobile phone. Also health education in terms of mental health issues will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12. Comparison: Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given. Outcomes: The primary outcomes are PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS score at month 12.

Family Spirit Strengths

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. They often find working, studying and relationships hard. IBD can't be cured, so it lasts for life. When IBD is hard to treat, we use advanced treatments, but these don't always work. When they do work the effect can wear off. This happens in 2 of 5 people within a year in research studies. There are some things that we know make them wear off. There are lots more reasons that we don't understand yet. We think anxiety, depression and stress make these treatments more likely to wear off. Previous research has suggested that people with IBD do worse if they have anxiety, depression or stress. The investigators want people with IBD to complete questionnaires to see if they are affected by anxiety, depression or stress when they are taking advanced therapies. The investigators will follow those people to see if the effect of their treatment wears off. People living with IBD will contribute to the running and fine tuning of this research. Many of those that have engaged with us so far have said that their disease was worse when their mental health was worse. They were generally supportive of this study to see how anxiety, depression and stress effects IBD in people using advanced therapies. The investigators have talked to a national charity about our work. They will help share the findings so that patients, care givers and other stakeholders will be able to read about them. The results will be published so that doctors and researchers can use them.

Improving Maternal Mental Health & SUD Screening and Treatment

The purpose of the study is to compare a text message-based mental health and substance use screening and referral to a treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online questionnaires. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Gii'Igoshimong: Sitting With Your First Family

The goal of this randomized wait-list control study is to understand the relationship between ceremony and substance use (SU), SU risk (e.g., SU severity, depressive symptoms) and protective factors (e.g., spirituality, community support). The main questions it aims to answer are: * Will adults enrolled in Gii'igoshimong show improved SU outcomes compared to those in control groups? * Will self-relevant processing networks activated during stimulus engagement increase from pre- to post- engagement in ceremony and at 6-month follow-up? Researchers will compare adults that complete Gii'igoshimong with those that do not complete Gii'igoshimong to see if health outcomes are different. After completing baseline assessments, participants will be randomized to complete Gii'igoshimong now (intervention) or after the participants have completed the 1 month and 6-month post assessments (waitlist control). All participants (intervention and waitlist control) within a cohort will complete 1 month and 6 month post assessments at the same time.

Randomized Controlled Trial on Precision Mental Health

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

Implementation Science to Improve School Ethos for Mental Health

The objective of the study is to identify the challenges and opportunities existing within the school ethos in implementing evidence-based interventions to improve youth mental health and to identify the most appropriate implementation strategies for improving mental health among young people in schools at Chennai, a city in Southern part of India, a low- and middle- income country setting.

GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

Background: Adolescence is a period of intensified emotional responses and occurs when mental health disorders commonly develop since adolescents are learning how to deal with powerful emotions. Globally, 15% of adolescents experience a mental disorder like depression or anxiety. However, adolescent mental health goes beyond mental disorders. It is state of mental well-being that allows individuals to deal with stressors, recognize their abilities, develop their activities well, and participate in society, providing a holistic approach that highlights the interplay between psychological well-being and other aspects of life. Given this perspective, a Lifestyle Medicine (LM) approach based on a multi-component framework is needed for assessing adolescents' mental health. This study aims to evaluate adolescents' (aged 14-19) mental health, identify and mitigate the risks of developing any mental health disorder as well as formulate comprehensive interventions to promote and increase their emotional wellbeing. Methods: Cross-sectional and longitudinal studies will be performed. Adolescents from Quito, Ecuador will be recruited using a simple random sampling technique. The minimum sample size is 385; however, to increase the precision of the estimates, a target sample of approximately 1000 participants will be established. Main outcome measure will be mental health using social determinants of health and lifestyle medicine factors. Conclusion: This research project will evaluate adolescents' mental health through a holistic and multiapproach evaluation and interrelate social determinants of health and lifestyle medicine variables to propose and design multidisciplinary strategies and interventions to prevent and mitigate mental health outcomes in adolescents. Additionally, the results will be useful in informing public health authorities to evaluate or modify current policies