Clinical Research Directory

Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well-being of Young Adolescents in Hong Kong - A Cluster RCT Study

The goal of this trial is to evaluate the effectiveness, user perception, and applicability of the e CAMP intervention for improving mental well-being and reducing depressive symptoms among young adolescents. Primary Research Question 1. Does the e-CAMP intervention significantly reduce depressive symptoms among students, as measured by the Patient Health Questionnaire-9 (PHQ-9)? Secondary Research Questions 2. To what extent does the e-CAMP intervention enhance mental health knowledge and literacy among adolescents, as assessed by the Chinese-version Universal Mental Health Literacy Scale for Adolescents (UMHL)? 3. How does participation in the e-CAMP intervention impact students' smart device usage behaviors, as measured by the Smartphone Addiction Scale (SAS)? 4. Does the e-CAMP intervention effectively reduce sedentary behavior and increase total physical activity, as measured by the Global Adolescent and Child Physical Activity Questionnaire (GAC-PAQ) and smartwatch data? 5. How do participants and teachers perceive the applicability, acceptability, and sustainability of the e-CAMP intervention, based on survey and in-depth interview feedback guided by the RE-AIM framework? Method : A prospective cluster RCT with two arms according to the cluster CONSORT 2010 checklist and guide \[23\] will be conducted. Eight eligible schools will be assigned randomly to the intervention or usual care group. The process evaluation will be guided by the RE-AIM framework \[19-20\]. Convenience sampling will be used to recruit eligible students ( about 320 ) from eight primary or secondary schools in Hong Kong. All schools are under Education Bureau of Hong Kong. The inclusion criteria will be students at participating schools who can read Chinese and are aged 11-15 (P5 to F2), with parental consent. Students with known physical (musculoskeletal) or cognitive/mental problems that would compromise physical exercise or our intervention or outcomes will be excluded. experimental group ( e-CAMP mobile app group) : In addition to receiving the usual school care, participants in intervention schools will be provided with a QR code and installation guide and instructed to install the e-CAMP mobile app. Participants will be encouraged to use the e-CAMP app at least thrice weekly during the first 8 weeks of the intervention. Each usage session is expected to last approximately 10-15 minutes. Control group : Participants in control schools will receive usual school care, a 45-minute health talk delivered by a nurse. A PowerPoint handout will be provided to all participants after the health talk.

A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...

Background: As of 2021, almost 45 million people in the United States were foreign-born immigrants. South Asians, including people from Bhutan, are the fastest-growing immigrant subgroup in the US. Their income and education levels are higher than the US average. Yet they have worse physical and mental health outcomes than their White US-born counterparts. These risks include type 2 diabetes and obesity. Objective: This natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US. Eligibility: Adults aged 18 years or older who identify as Bhutanese and live in the US. Design: Participants will be recruited and screened by the Bhutanese Community of Central Ohio (BCCO). They will have 1 visit to the BCCO s Arogya Clinic in Reynoldsburg. The visit will last 2 hours. Participants will take a survey; they may use either English or Nepali. They will answer questions about their background; their experiences living in the US; and how their customs and habits might have changed. They will also be asked about their experiences with discrimination; their mental health and well-being; their community; quality of life; and overall physical health. The survey will take 60 minutes. Participants will also speak with a researcher. They will be asked how they feel about providing biological samples; these may include saliva, blood, and urine. Their answers will be audio recorded.

OurChild: A Health IT Solution to Reduce Minority Health Disparities

Chinese American immigrant families are a fast-growing immigrant group with unmet early childhood mental health needs. The team proposes to design, build, and implement OurChild, an integrated mHealth/EHR solution to increase access to early childhood mental health knowledge and mental health services and resources for Chinese American children ages 2-6 years old and their parents in the Sunset Park Brooklyn.

Impact of a Medical-Financial Partnership Intervention on Parent Mental Health, Perinatal Outcomes, and Child Developmental Risk

Poverty and financial stress are key social drivers of health and root causes of worse health beginning in pregnancy, continuing into childhood, and extending over the life course, but clinical tools to address the health impacts of poverty and financial stress are needed. This trial is of a multi-site medical-financial partnership intervention to examine its effect on parent, perinatal, and child outcomes, as well as health care utilization, and family financial and social risk. This pragmatic randomized clinical effectiveness trial will examine the impact of a clinic-based medical-financial partnership intervention beginning either 1) in the newborn period (Intervention Arm 1) or 2) during prenatal care (Intervention Arm 2) versus controls on parent, child, and family/household outcomes.

Health Without Barriers/Salud Sin Barreras- Northern Colorado

The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.

Public Messaging to Increase Treatment Seeking for Veterans at Risk for Suicide

The risk for suicide increases by nearly 50% in the first year that service members transition from the military to civilian life underscoring the need for effective strategies to facilitate help seeking among Veterans vulnerable to self-directed violence. Yet despite a great need for treatment, more than half of returning Veterans at risk for suicide do not initiate mental health services. VA has embarked on the regular use of communication campaigns as part of a public health approach designed to reach the larger Veteran population with messages promoting help seeking. However, what types of messages effectively change beliefs and behaviors for at-risk Veterans resistant to seek treatment is unclear. The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. This represents the first study to systematically develop public messaging strategies for populations at risk for suicide.

Anxiety in Children and Families During MRI Under Anesthesia

This prospective randomized controlled study evaluates the impact of age-appropriate therapeutic play and structured parental briefing on perioperative anxiety during pediatric MRI under sedation. Children aged 2-11 were assigned to either a multi-modal intervention group or a standard care control group. The primary objective was to measure child anxiety using the Modified Yale Preoperative Anxiety Scale (m-YALE) after the intervention. Secondary objectives included assessing parental anxiety via VAS/APAIS and measuring overall parental satisfaction in the recovery room. The study aims to demonstrate that a brief psychological intervention can effectively reduce stress for both children and their parents, even during prolonged hospital waiting times.

Development of a Multilevel HIV Prevention Intervention for the Emergency Department

The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits.

Disparities in Mental Health Screening and Support

To develop and administer online surveys to cancer patients and their families across diverse regions within the EU to detect possible disparities in their access to mental health screening and psychological-cognitive support

CanSOLVE 2.0 Theme 3.1 Mind the Gap - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot

The goal of this pilot implementation study is to implement and evaluate a 13-week dialectical behavioural therapy (DBT) skills training program to address challenges to mental health and mental wellbeing in people who have recently started facility-based hemodialysis or those who may start within the next 6-12 months.

Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

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.

Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

In this study, caregivers of toddlers with a high likelihood of developing mental health challenges will participate in a parenting program, Family Check-Up® Online (FCU-O), and complete assessments related to their child's behavior and their caregiving practices. FCU-O is a parenting support program that offers tools and guidance to support children's emotional and behavioral development. The program is delivered through a secure website that can be accessed via computer or phone at participating caregivers' convenience. Caregivers will complete the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool, a risk calculator that screens for early signs of future mental health challenges, at their child's 24- or 30-month well-check visit with their pediatrician. Clinicians will use the DECIDE tool risk calculator score to refer caregivers of at-risk children to FCU-O. Caregivers may use FCU-O independently, or they may work with a trained coach who will facilitate their use of the program. Participation is open to caregivers who are referred to FCU-O based on their DECIDE risk calculator score by their child's pediatrician, and is available in English or Spanish. Participants will also complete assessments via survey and direct observation before beginning FCU-O, and 6- and 12-months after their referral to FCU-O.

Does Social Media Impact Adolescent Mental Health?

The mental health of adolescents in the United States has seen a steep decline, roughly coinciding with the increasing popularity of social media and smartphones. But does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria? In this study, the investigators will conduct the first field experiment in 10-14-year-olds to examine whether, how, and for whom social media harms mental health.

Telephone-Based Care Coordination for Services Addressing Childhood Adversity

The goal of this study is to learn how telephone-based screening and care coordination impacts children experiencing adverse childhood events (ACEs). The main questions are: 1. Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services? 2. Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing? 3. Does telephone-based screening and care coordination for children experiencing ACEs improve child social and emotional health? Researchers will compare families who have been randomly selected to receive telephone-based screening and care coordination with those who will receive usual care at their clinic. Participants will: * Be randomly assigned to receive usual care or usual care plus telephone-based screening and care coordination (the intervention) * If selected for the intervention, be connected to 211 Los Angeles to receive screening and care coordination for up to 6 months * Complete four surveys via interview; surveys will be done at enrollment and 1 month, 6 months, and 12 months following enrollment * Agree to allow researchers to review their child's medical records to collect information about their child's health, screenings, diagnoses, and referrals.

Health Benefits of Dance Exercise

In Greece, people of different age groups, including young children to older adults, participate in dance exercise training. Although it is well-known that regular participation in dancing is associated with benefits such as entertainment, socialization and increased physical activity, the long-term effects of dancing on metabolic and mental health as well as physical performance remain largely unknown. Therefore, the aim of this study is to investigate the effects of a 6-month dancing exercise intervention on metabolic and mental health and physical performance in premenopausal and postmenopausal women.

Essential Coaching Postpartum: Evaluating a Parent-focused Postpartum Text Message Program in Nova Scotia

The transition to parenthood is often an exciting yet hard period for parents. In the first year after a new baby, many parents feel less confident, have more anxiety and depression, and feel more isolated and alone. During this time, many parents use their phones and the Internet to seek out information and support. Thus, the investigators are exploring the opportunity of using mHealth, or mobile health, to provide information directly to parents after the birth of their first baby. The investigators have developed a program for both birthing and non-birthing parents called the Essential Coaching Postpartum program. This program provides 332 parents with text messages sent for 6 weeks after birth to share information on newborn care and parent outcomes. This will be tailored based on whether they are the birthing parent (Essential Coaching for Every Mother) or non-birthing parent (Essential Coaching for Every Partner). The investigators will evaluate this program by comparing a group of parents who receive the messages to a group of parents do not receive any text messages. To determine the success of the Essential Coaching Postpartum program, the investigators will compare parents' confidence, anxiety, depression, and co-parenting between the two groups after six-weeks and six-months. The investigators believe that parents who get the text messages will have higher confidence and co-parenting outcomes and lower anxiety and depression. The investigator's goal with the Essential Coaching Postpartum program is to help make the first few weeks after a new baby less stressful by providing information and support directly to parents that they know they can trust.

Feasibility and Effectiveness of Gamified Digital Intervention to Prevent Alcohol and Mental Health Risks

This study evaluates the impact of a novel smartphone application on alcohol consumption, alcohol-related problems, and psychological well-being. Participants invited into the study are biological females between the ages of 18 and 69 years of age who signup to use the app and who live in the United States.

Mental Health After Dexmedetomidine for Electrical Storm

The goal of the research study is to measure mental health and quality of life indices of individuals treated for electrical storm (ES). The consequences of being admitted to an intensive care unit (ICU) with electrical storm as well as the treatments patients would have received, are currently not well understood. Understanding the mental health burden of these treatments among survivors can provide insights into how to improve care. This is a study consisting of patients who participated in the SEDATE trial (dexmedetomidine vs usual standard of care to treat ES in the ICU). Patients who consent to participate in this study will be asked to complete a set of questionnaires 3-6 months after their ICU admission. The purpose of the questionnaires is to measure indices of mental health and health-related quality of life. Each questionnaire will take about 5-15 minutes to complete. If patients have a scheduled follow-up at the University of Ottawa Heart Institute, a member of the research team will meet with them during their clinic visit to complete the questionnaires. Otherwise, they can be completed over the telephone.

Supporting Treatment Access and Recovery in Re-entry (STAR-R)

This application is aimed at testing a multicomponent intervention called "Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.

Targeting Fronto-Striatal Neural Circuitry Using Repetitive Transcranial Magnetic Stimulation to Reduce Irritability

This pilor study will use repetitive Transcranial Magnetic Stimulation (rTMS) as a noninvasive circuit-based neural modulation to test frontostriatal circuitry as a potential target to reduce irritability.

Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV

The proposed study will address the intersecting stigmas of HIV, violence and depression among adolescents and young adults (15-24) living with HIV (AYALHIV) in Zambia. The study will integrate a WHO-endorsed mental health approach into an existing HIV-stigma-reducing intervention, and refine measures of internalized and intersecting stigmas, to create and test the feasibility of Project YES+- a combined youth peer mentoring and lay mental health intervention. This research aims to shift HIV care and treatment for AYALHIV by addressing the multiple internalized and intersecting stigmas that impeded antiretroviral adherence and HIV viral suppression.

Foster Care Mental Health Family Navigator

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.

An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis

Ankylosing spondylitis is a chronic inflammatory rheumatic disease associated with pain, stiffness, reduced mobility, and impaired quality of life. In addition to physical symptoms, individuals with ankylosing spondylitis frequently experience depression, anxiety, stress, and sleep problems. However, existing mental health support is limited and often relies on static assessments and scheduled interventions, which may not respond to patients' fluctuating daily symptoms. This study aims to develop and pilot test a WeChat-based ecological momentary intervention to improve mental health in individuals with ankylosing spondylitis in China. The study is a prospective, parallel-group, assessor-blinded pilot randomized controlled trial. A total of 36 adults with ankylosing spondylitis and mild-to-moderate depression and/or anxiety will be randomized 1:1 to either an intervention group or a control group. The intervention group will first receive six brief video-based sessions on cognitive behavioral therapy-related skills during week 1. During weeks 2 to 5, participants will use a WeChat mini-program to complete daily ecological momentary assessments of pain, depression, and anxiety. Symptom-triggered intervention modules will then provide brief, tailored strategies such as cognitive restructuring, behavioral activation, relaxation exercises, self-compassion practice, and SMART goal setting. The control group will receive standard counseling and educational materials. The primary purpose of this pilot study is to assess feasibility and acceptability, including recruitment, adherence, attrition, engagement, usability, satisfaction, and adverse events. Preliminary effects on depression, anxiety, stress, pain, insomnia, illness perceptions, coping strategies, and quality of life will also be explored at baseline, post-intervention, and 4-week follow-up.

French Validation of the Recovery Assessment Scale (RAS-FR)

The VAL-RAS-FR study aims to cross-culturally adapt, validate, and develop derived versions of the Recovery Assessment Scale (RAS), an internationally used self-report measure of subjective recovery in mental health. The study will include 260 adult psychiatric patients receiving care at EPSM Metz-Jury in both inpatient and outpatient settings. Participants will complete the French version of the RAS (RAS-FR), the WHOQOL-BREF, and additional self-report questionnaires. A subgroup of participants will complete the RAS-FR again after one month to assess test-retest reliability. The study will also explore existential aspects of recovery through the development of the RAS-FR-EX (Existential Extension) and support the development of a shorter version, the RAS-FR-SF (Short Form), for clinical and research purposes.