[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mental-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mental-health":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,177,0,25,[9,48,80,111,146,171,193,217,244,273,300,330,361,401,430,456,492,513,542,566,594,618,638,658,679],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100592309","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--100592309",false,"NCT06991751","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 ...","A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Bhutanese Community of Central Ohio Health Study to Identify Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating Health Disparities From a Cross-Sectional Study","* INCLUSION CRITERIA:\n\nTo participate in this study all of the following criteria must be met:\n\n* Adults (aged 18 years and older) living in the United States\n* Identify as Bhutanese, which will be defined as those individuals that resided or had\u002Fhave their closest relatives residing in the Kingdom of Bhutan\n* Bhutanese identity will also include those that self-identify as Bhutanese-Nepali or Bhutanese American\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Any South Asian participants that do not identify as Bhutanese.\n* Pregnant at time of study or screening","ALL","18 Years","100 Years",{"count":21,"type":22},50,"ESTIMATED","OBSERVATIONAL","Background:\n\nAs 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.\n\nObjective:\n\nThis natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US.\n\nEligibility:\n\nAdults aged 18 years or older who identify as Bhutanese and live in the US.\n\nDesign:\n\nParticipants 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.\n\nParticipants 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.\n\nParticipants 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.",[26,27],"Cardiometabolic Risk Factors","Mental Health",[29,30,31,32,33,34],"Bhutanese","South Asian","Community engaged","Biospecimen perceptions","Epidemiology","Syndemic","NOT_YET_RECRUITING","2026-08-21",{"date":38,"type":39},"2026-08-24","ACTUAL",{"date":41,"type":22},"2026-08-27",{"date":43,"type":22},"2026-08-31",{"name":45,"class":46},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100633329","trial-phase-syndemic-adapted-medly-uganda-100633329","NCT07525271","Trial Phase: Syndemic Adapted Medly Uganda","An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)","SAMU","Inclusion Criteria:\n\n* Patient at a participating HIV clinic site\n* Currently living in Uganda with no intention of moving abroad in next 2 years\n* Access to a mobile phone\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.\n\nExclusion Criteria:\n\n* No access to a mobile phone\n* Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW\n\nHealthcare Workers\u002FCaregivers Criteria:\n\n* Age \\>=18 years\n* Healthcare worker at participating site or caregiver for study participant at site\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant",{"count":57,"type":22},1500,"INTERVENTIONAL",[60],"NA","The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.",[27],[64,65,66,67,68],"Depression","Anxiety","HIV","Alcohol Use Disorder","hypertension","2026-08-18",{"date":71,"type":39},"2026-08-19",{"date":73,"type":22},"2026-09",{"date":75,"type":22},"2028-06",{"name":77,"class":78},"Yale University","OTHER",3,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":58,"phases":89,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":47},"100591839","khanya-ekhaya-a-home-based-intervention-100591839","NCT06985641","Khanya Ekhaya: A Home-Based Intervention","Home-Based Community Health Worker Support for Mental Health Among People Living With HIV in South Africa: A Hybrid Effectiveness Implementation Trial","Inclusion Criteria:\n\n* at least 18 years old\n* must be a CHW who conducts home visits for people with HIV newly initiating or re-initiating ART at the approved clinic site\n\nExclusion Criteria:\n\n-Unable or unwilling to complete informed consent and study procedures in English, isiXhosa, or Afrikaans",{"count":88,"type":22},119,[60],"Mental health conditions, such as depression, anxiety, and harmful alcohol use are prevalent among people with chronic diseases, including HIV, and contribute to poor engagement in care. There is a need to address untreated mental health problems. Community health workers (CHWs) are frontline workers who play a central role in supporting vulnerable individuals to stay in care, including seeking people living with HIV who are newly initiating antiretroviral therapy (ART) or re-initiating after a period of care disengagement. CHW-delivered interventions are promising for improving engagement and retention in care. Yet, these programs rarely address mental health -a significant barrier to chronic disease care engagement and treatment. An approach that moves beyond providing care in the clinic setting is needed.\n\nCommunity-delivered mental health care shows promise for integration into broader community health care services for people with chronic conditions, such as HIV. However, as CHWs are taking on more mental health care roles and community-based work, our team's preliminary research has demonstrated that high levels of stress and burnout are important considerations for successful implementation of these models.",[27,92,93,94,95,96,97],"Community Health Workers","Training","Global Health","Burnout","Well-being","Natured-informed Therapy",[92,99,94,100,101,95,96,102],"Health Personnel","Health Care Seeking Behavior","Attitude of Health Personnel","Nature-informed therapy","2026-08-14",{"date":69,"type":39},{"date":106,"type":22},"2026-08-17",{"date":108,"type":22},"2026-11-23",{"name":110,"class":78},"University of Maryland, College Park",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":58,"phases":122,"briefSummary":123,"conditions":124,"keywords":131,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":47},"100652112","digital-mental-health-for-asian-americans-100652112","NCT07771322","Digital Mental Health for Asian Americans","Anise Health: Digital Mental Health for Asian Americans","Clinician eligibility\n\nInclusion Criteria:\n\n* New clinicians who have never provided services on the Anise Health platform\n\nExclusion Criteria:\n\n* Existing clinicians on the Anise Health platform\n\nClient eligibility\n\nInclusion Criteria:\n\n1. Asian American adults (age 18-90 years) who seek mental health services\n2. resides in states in which Anise Health clinicians are licensed to provide care,\n3. has access to reliable internet connection,\n4. has signed the Informed Consent form prior to participants' entry into the study.\n\nExclusion Criteria:\n\nIndividuals seeking\n\n1. treatment for serious mental illness such as bipolar disorder and psychotic disorders,\n2. diagnosis for ADHD or Autism Spectrum Disorder,\n3. treatment for eating disorder and substance use disorder,\n4. attention for active suicidal ideation with plan and intent, or\n5. persons lacking relevant decision-making capacity, or otherwise requiring a personal representative to indicate consent\u002Fauthorization on their behalf, would be ineligible.",true,"90 Years",{"count":121,"type":22},80,[60],"Aim 1: Assess clinicians' receptiveness and potential use of Anise's online platform digital tools for managing sociocultural stressors and revise the tools for implementation. We will recruit 8 new clinicians (intervention group) who will receive training and provide feedback on the digital tools.\n\nAim 2: Evaluate the initial efficacy of the online platform digital tools for managing the impact of sociocultural stressors with 64 Asian American clients. The intervention group clinicians (receiving training and using the digital tools) and newly recruited 8 clinicians (not receiving training and not using the digital tools) for the control group will work with 4 clients each. The clinical outcome data of the clients will be analyzed to examine differences in the client prognosis between the control and intervention group.\n\nA successful outcome of this project will be digital materials that effectively address the impact of sociocultural stressors for Asian Americans on Anise Health's digital health platform.",[27,125,126,127,128,129,130],"Cultural Adaptation","Psychotherapy","Mood Disorders","Culturally Responsive Care","Asian","Digital Health Intervention",[132,133,134,135,125,129,136],"mental health","Asian American","Digital Mental Health","Anise Health","Digital Health","RECRUITING","2026-08-13",{"date":69,"type":39},{"date":141,"type":39},"2026-07-20",{"date":143,"type":22},"2027-04-30",{"name":145,"class":78},"University of California, Berkeley",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":118,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":58,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":167,"leadSponsor":169,"locationsCount":47},"100639240","effect-of-a-telephone-reminiscence-intervention-on-mental-health-100639240","NCT07576855","Effect of a Telephone Reminiscence Intervention on Mental Health","Strengthening Bonds: A Telephone Reminiscence Intervention to Reduce Social Isolation and Improve Mental Health in Rural Older Adults","TRIM","Inclusion Criteria:\n\n* Older adults aged 60 years or older living in a rural area and their caregivers aged 18 or older..\n* Able to read and speak English.\n* Living in a rural area as defined by the U.S. Census Bureau.\n* Has an informal caregiver (family member, partner, friend, or neighbor) willing to participate, or is an informal caregiver of an eligible older adult.\n* Able to participate in telephone-based activities.\n\nExclusion Criteria:\n\n* Significant hearing impairment that would interfere with telephone participation.\n* Cognitive impairment as indicated by three or more errors on a brief cognitive screening assessment.\n* Participation in the program development phase of this study.","60 Years",{"count":156,"type":22},170,[60],"The goal of this study is to learn whether a telephone-based program that helps people share life memories can reduce loneliness and improve mental well-being, life satisfaction, and social support in older adults and their caregivers living in rural areas.\n\nThis study has two parts. In the first part, researchers will gather feedback from a small group of older adults and informal caregivers to see if the updated telephone reminiscence program works well and is easy to use.\n\nIn the second part, researchers will test the telephone reminiscence program in a clinical trial study to see whether the updated telephone reminiscence program reduces loneliness and improves social support, life satisfaction, and mental well-being in older adults and their caregivers. The researchers will also examine how the program impacts how often and for what reason you reminisce.\n\nThe main questions this study aims to answer are:\n\n* Does the telephone reminiscence program improve social support, life satisfaction, and mental well-being and reduce loneliness in rural older adults and their caregivers? How does the telephone reminiscence impact how often and for what reason participants reminisce?\n* How often and how long do participants use the program?\n* How satisfied are older adults and informal caregivers with the program? In this study researchers will compare participants who begin the telephone reminiscence program right away with participants who start the program after a 12-week waiting period to see whether starting the program earlier leads to better outcomes.\n\nParticipants will:\n\n* Take part in telephone calls 3 times a week that invite older adults to talk about their life experiences.\n* Answer brief survey questions about social support, loneliness, and mental well-being, and life satisfaction over time.\n* Include both older adults and their informal caregivers, who may also participate by recording questions in their own voice.",[27],[161,162,163,164],"Older Adults","Telephone-Based Intervention","Reminiscence","Mental Well-Being",{"date":106,"type":39},{"date":73,"type":22},{"date":168,"type":22},"2027-08",{"name":170,"class":78},"University of Connecticut",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":178,"maxAge":18,"enrollmentInfo":179,"targetDuration":4,"studyType":58,"phases":181,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":47},"100635049","enlace-familiar-supporting-the-mental-health-of-latino-adolescents-100635049","NCT07547631","Enlace Familiar: Supporting the Mental Health of Latino Adolescents","Enlace Familiar Mental Health Intervention","Our inclusion criteria for youth participation include:\n\n* High school-age adolescents, ages 14-18 who self-identify as Latino\n* Adolescents scoring between 3-12 on the Patient Health Questionnaire-4 (PHQ-4), a brief mental health screening tool for anxiety and depression\n* Adolescents who are not currently receiving mental health treatment or in the past 12 months\n* Adolescents fluent in Spanish or English\n\nOur inclusion criteria for parent participation include:\n\n* Parents of High school-age adolescents, ages 14-18 who completed the intervention (T3)\n* Parents fluent in Spanish or English\n\nOur inclusion criteria for Community Health Worker participation include:\n\n● CHW who implemented our intervention\n\nOur Exclusion Criteria: for youth participation include:\n\n* youth not fluent in English or Spanish\n* youth currently receiving mental health treatment or who have received it in the past year\n\nOur exclusion criteria for parent include:\n\n* parents of High school-age adolescents, ages 14-18 who did not completed the intervention (T3);\n* parents not fluent in Spanish or English\n\nOur exclusion criteria for Community Health Worker participation include\n\n● CHWs not involved in our intervention.","14 Years",{"count":180,"type":22},64,[60],"The goal of this clinical trial is to pilot and evaluate Enlace Familiar, a culturally responsive intervention designed to support Latino adolescents in discussing their mental health needs with caregivers or other trusted adults. The study will examine the feasibility and acceptability of the intervention and examine its potential impact on mental health communication among Latino adolescents ages 14-18 experiencing mental health concerns. Participants will be randomized into two groups, with 32 adolescents assigned to the Enlace Familiar intervention and 32 adolescents assigned to a control condition. The intervention will be implemented in partnership with community health workers (CHWs), who will serve as culturally relevant facilitators.\n\nThe main questions this study aims to answer are:\n\n1. Is Enlace Familiar feasible and acceptable for Latino adolescents when delivered by CHWs?\n2. Does participation in Enlace Familiar improve adolescents' discussions of mental health needs with caregivers or other trusted adults?\n\nParticipants will:\n\n* Complete baseline assessments related to mental health communication, attitudes toward mental health, mental health literacy, and engagement in mental health services.\n* Participate in the Enlace Familiar intervention, delivered by trained CHWs.\n* Complete follow-up assessments to evaluate changes in primary and secondary outcomes.\n* Participate in qualitative interviews or feedback activities to provide information about the acceptability and perceived usefulness of the intervention.\n\nResearchers will use a mixed methods design to evaluate intervention feasibility and acceptability and to explore preliminary changes in adolescent mental health communication following participation in the intervention.",[27],[185],"Adolescent",{"date":106,"type":39},{"date":188,"type":22},"2026-10",{"date":190,"type":22},"2029-01",{"name":192,"class":78},"University of Michigan",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":201,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":58,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100652527","codepad-iii-collaborative-outcomes-of-depression-and-pain-associated-with-delivery-iii-100652527","NCT07773259","CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)","Collaborative Psychological Model for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)","CODEPAD-III","Inclusion Criteria (Mothers):\n\n* Healthy (American Society of Anesthesiologists (ASA) physical status II);\n* Parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);\n* With a singleton fetus;\n* Planning to have childbirth and delivery at study site;\n* Patients with prior mental health history, and current active psychiatric care will also be recruited.\n\nInclusion Criteria (Fathers):\n\n* Identified partner (e.g., husband or significant other) of the enrolled pregnant patient;\n* Aged 21 years and above;\n* Able to understand the study procedures and willing to participate in the 8 weeks postpartum assessment.\n\nExclusion Criteria (Mothers):\n\n* History of intravenous drug or opioid abuse;\n* Previous history of chronic pain syndrome.\n\nExclusion Criteria (Fathers):\n\n* Unable to provide informed consent (e.g., cognitive impairment, language barriers without available translation support);\n* Any condition that, in the opinion of the investigators, would make participation inappropriate (e.g., severe psychiatric or medical condition).","21 Years",{"count":203,"type":22},3470,[60],"The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after childbirth.\n\nThe study site proposes a Collaborative Psychological Model (CPM) consisting of music listening, customized mobile application on psychological strategies, telephone-based support, with monitoring (mobile electronic surveys, wearable-based vital sign monitoring) to effectively prevent, detect, monitor, and treat depression and persistent pain after childbirth. The study will determine if using the CPM will reduce the risk of having depression associated with childbirth. The study will also find out whether the CPM will reduce the depressive symptoms in women who undergo labor that may have increased depression risk. This clinical study will involve 2042 women undergoing childbirth at KK Hospital. In addition, up to 1428 patients' partners (fathers) will also be recruited for the week 8 postpartum assessment.\n\nThe study findings will improve healthcare for women in the community by incorporating digital psychological strategies to manage depression and persistent pain after childbirth. The CPM will also guide future directions to customize an individual's healthcare needs and to improve transition from hospital to community care for women after childbirth.",[64,207,208,27],"Postpartum","Pain","2026-08-12",{"date":71,"type":39},{"date":188,"type":22},{"date":213,"type":22},"2031-12",{"name":215,"class":216},"KK Women's and Children's Hospital","OTHER_GOV",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":118,"sex":223,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":58,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":47},"100497921","understanding-the-role-of-doulas-in-supporting-people-with-pmads-100497921","NCT05763537","Understanding the Role of Doulas in Supporting People With PMADs","Inclusion Criteria:\n\n* Participants must be over the age of 18\n* Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment\n* Live in a HRSA-designated rural area of Montana\n\nExclusion Criteria:\n\n* They are under the age of 18\n* Not currently pregnant\n* Not between 13-26 gestational weeks at the time of enrollment\n* If they do not live in a HRSA-designated rural are of Montana.","FEMALE",{"count":225,"type":22},75,[60],"Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.",[229,230,231,232,233,27,234,235,64,236],"Maternal Health","Pregnancy","Delivery, Obstetric","Self Efficacy","Social Support","Substance-Related Disorders","Postpartum Depression","Mental Health Services",{"date":103,"type":39},{"date":239,"type":39},"2024-11-26",{"date":241,"type":22},"2026-12-31",{"name":243,"class":78},"University of Montana",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":58,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":47},"100649452","reducing-stigma-and-building-employability-skills-for-young-people-with-hiv-in-zambia-100649452","NCT07732660","Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia","Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia","Inclusion Criteria:\n\n* Age 18 to 24 years\n* Confirmed HIV-positive status, verified using health records obtained from health facilities with participant consent\n* Residing in the Chipata, Katete, or Lundazi Districts of Zambia's Eastern Province\n* Currently receiving HIV treatment, or previously initiated but disengaged from HIV treatment (stratified purposive sampling will be used to enroll roughly equal proportions of youth currently in care and those who have dropped out of care)\n* Reports at least one indicator of economic vulnerability, defined as any of the following: unemployed or without a regular source of income; not attending school or post-secondary education; or individual income below Zambia's national poverty line\n\nExclusion Criteria:\n\n\\- HIV-negative or unknown status","24 Years",{"count":253,"type":22},100,[60],"The goal of this clinical trial is to learn if a program called Kupambana can improve mental health and HIV care outcomes in young people with HIV in Zambia by combining stigma-reduction support with financial and job-skills training. The main questions it aims to answer are whether Kupambana is feasible and acceptable to young people with HIV and whether it improves mental health, reduces stigma, and improves progress along the HIV care continuum, such as staying in care and taking HIV medicine as prescribed. Researchers will compare young people who participate in Kupambana with those who receive a one-time financial literacy training session (usual care) to determine whether Kupambana leads to greater improvements in stigma, mental health, and HIV care outcomes. Participants will complete a baseline questionnaire and then be randomly assigned to either the Kupambana program or the one-time financial literacy training. Those assigned to Kupambana will attend eight weekly peer-led support group sessions focused on reducing HIV- and poverty-related stigma, receive a voucher for technical and vocational education and training, and attend a one-time financial literacy session. Those assigned to the comparison group will attend only the one-time financial literacy session. All participants will complete follow-up surveys at the end of the program and again 3 and 6 months later.",[66,27,257],"Treatment Adherence",[259,260,261,262,263,264],"HIV Infections","Social Stigma","Poverty","Young Adult","Zambia","Vocational Education","2026-08-11",{"date":209,"type":39},{"date":268,"type":22},"2026-09-03",{"date":270,"type":22},"2027-10",{"name":272,"class":78},"University of North Carolina, Chapel Hill",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":280,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":58,"phases":284,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":4},"100651112","sibling-caregiver-cmc-pilot-study-100651112","NCT07756502","Sibling Caregiver CMC Pilot Study","Caring for the Mental Health of Sibling Caregivers of Children With Medical Complexity: a Pilot Study","Inclusion Criteria:\n\n* Have a sibling with medical complexity followed by the SickKids Complex Care program\n* Age 10 to 17 (inclusive)\n* Capable of completing the study measures independently or with the help of translation services\n\nExclusion Criteria:\n\n\\- Siblings who do not meet the three inclusion criteria","10 Years","17 Years",{"count":283,"type":22},63,[60],"Children with medical complexity require intense caregiving from their parents and other health care providers, such as family doctors and medical specialists. These children have complex and lifelong medical conditions, and can be dependent on technology to help them breathe, move, or eat. From a young age, siblings of children with medical complexity typically assume caregiving roles to support their families. Caregiving may be associated with increased depression and anxiety in siblings, disruptions in routine, parental neglect, and constant changes. There is a gap in research on, and supports for, the mental health of these siblings.\n\nThe goal of this study is to understand how to best support the mental health of siblings of children with medical complexity. A new model of support that involves measuring mental health symptoms in siblings age 10-17 through surveys and a mental health assessment conducted by social workers was created. Siblings who need support can be referred to social work and child psychiatry services that are integrated in the health care team the family already has a relationship with. By using screening and built-in supports, the investigators hope to create a pathway for siblings that is easy to access and proactive.\n\nSocial workers can provide talk therapy to help siblings manage difficult emotions. Psychiatrists can provide a medical diagnosis if the sibling meets the criteria for an illness such as depression or anxiety. Psychiatrists can also recommend medications or resources to help siblings manage symptoms.\n\nThis is a pilot study, meaning the investigators are exploring a new model and would like to gather more information on whether it is realistic to run this model, whether siblings will use it, and to gather information on sibling mental health patterns. The investigators will also be interviewing siblings so they can share their experiences with caregiving and any challenges with mental health support. Findings from this study can inform a larger, more robust study to measure how effective the model is compared to normal care.\n\nWhile sibling research is new, the investigators have already conducted a similar study where this model was tested on parents of children with medical complexity. The investigators found parents used the model and were linked to supports quickly.",[287,288,27],"Children With Medical Complexity (CMC)","Siblings",[290,291,132],"children with medical complexity","siblings","2026-08-10",{"date":209,"type":39},{"date":295,"type":22},"2026-09-01",{"date":297,"type":22},"2028-09-01",{"name":299,"class":78},"The Hospital for Sick Children",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":118,"sex":308,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":58,"phases":311,"briefSummary":312,"conditions":313,"keywords":317,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":47},"100651615","gwan-enjoy-life-a-peer-supported-mental-health-mentoring-intervention-to-improve-engagement-in-care-among-sexual-minority-men-living-with-hiv-in-jamaica-100651615","NCT07762612","\"Gwan Enjoy Life:\" A Peer-Supported Mental Health Mentoring Intervention to Improve Engagement in Care Among Sexual Minority Men Living With HIV in Jamaica","\"Gwan Enjoy Life:\" Protocol for a Randomized Controlled Trial to Test a Peer-Supported Mental Health Intervention to Improve Engagement in Care for High-Priority Sexual Minority Men Living With HIV","GwanEnjoyLife","Inclusion Criteria:\n\n* Self-identified as a cisgender man who have sex with men\n* Age 18 and older,\n* Living in one of the 14 parishes\n* Able to offer informed consent\n* Living with HIV (currently engaged, marginally engaged, and not engaged in care)\n* Provide consent to clinic staff to review medical records.\n\nExclusion Criteria:\n\n* Self-reported participation in another HIV care engagement study\n* Unable to understand the consent process\n* Planning on relocating out of Jamaica over the next 12 months.","MALE",{"count":310,"type":22},60,[60],"Sexual minority men (SMM) in Jamaica face many challenges that affect their health and well-being. Although they make up a relatively small part of the population, they are much more likely to be living with HIV than the general public. Many also experience discrimination because of their sexual orientation, HIV-related stigma, violence, poverty, unstable housing, limited educational opportunities, and barriers created by laws and social attitudes. These experiences can have a serious impact on mental health, leading to problems such as depression, anxiety, trauma, and thoughts of suicide. Many people also face barriers to getting mental health care because of stigma or a lack of services that are welcoming and appropriate for their needs. These challenges can make it difficult for people living with HIV to stay connected to medical care and take their HIV medications consistently. Missing appointments or stopping treatment can make it harder to keep the virus under control and can lead to poorer health over time. While researchers know that stigma, discrimination, and violence affect health, we still do not fully understand how these experiences work together to influence HIV care among sexual minority men in Jamaica.\n\nTo help address these challenges, we developed the Gwan Enjoy Life program, a culturally relevant program designed specifically for sexual minority men living with HIV in Jamaica. The program combines practical coping skills, emotional support, and strategies for managing the effects of trauma and stress. It is led by trained peer mentors who are also living with HIV, allowing participants to learn from people who understand their experiences. The six-session program gives participants the option of meeting one-on-one with a peer mentor or participating in a small group, depending on what they find most comfortable. The program will be tested in partnership with Jamaica AIDS Support for Life (JASL), one of Jamaica's leading HIV service organizations. Sixty participants from JASL clinics in Kingston and St. Andrew, St. James, and St. Ann will take part in the intervention. Participants will be randomly assigned to either receive the Gwan Enjoy Life program or continue with their usual care, and they will be followed for one year. Researchers will examine whether the program improves mental health, strengthens social support, helps participants stay engaged in HIV care, and improves medication adherence.\n\nThe goal of the intervention is to determine whether the Gwan Enjoy Life intervention is a practical and effective program that can be expanded to reach more people across Jamaica. The findings will help researchers, healthcare providers, and policymakers better understand how stigma, violence, and mental health affect HIV care and will support the development of programs that improve the health and well-being of sexual minority men living with HIV.",[27,66,314,315,316],"Pyschological Distress","Suicidal Ideation","Engagement in HIV Care",[27,66,318,319,320,321],"Engagement in Care","Jamaica","Sexual Minority Men","Psychological Distress","2026-08-07",{"date":138,"type":39},{"date":325,"type":22},"2026-08-25",{"date":327,"type":22},"2027-08-30",{"name":329,"class":78},"University of California, San Francisco",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":337,"targetDuration":4,"studyType":58,"phases":339,"briefSummary":340,"conditions":341,"keywords":345,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":47},"100651459","neurocomputational-dynamics-of-cooperation-100651459","NCT07759973","Neurocomputational Dynamics of Cooperation","COBRA","Online cohort inclusion criteria:\n\n* English fluency\n* US residency\n* Owner of a desktop or laptop computer\n* Adult aged 18-100\n\nOnline cohort exclusion criteria:\n\n* Participants who have participated in an earlier version of the study\n* Inability to consent\n* Self-reported history of neurological disorder or brain damage\n* Self-endorsed history of psychosis or mania\n\nClinical cohort inclusion criteria:\n\n* Adult aged 20-60 years old\n* English fluency\n* Owner of a smartphone with celluar data\n\nClinical cohort exclusion criteria:\n\n* Inability to consent\n* Self-reported history of neurological disorder or brain damage\n* Clinician-rated psychosis or mania in the last 6 months\n* Current intoxication or withdrawal\n* Estimated IQ \\\u003C 70\n* fMRI safety concerns\n* Pregnancy\n* Lack of stable psychiatric treatment (e.g., medication dosage, therapy modality) for the previous two months\n\nInformant inclusion criteria:\n\n* Adult aged 18+ years old\n* English fluency\n* Owner of a smartphone with celluar data\n* Must have 4+ interactions\u002Fweek with the participant for at least 6 months prior to study baseline\n\nInformant exclusion criteria:\n\n\\- Lack of a smartphone with cellular data at study baseline",{"count":338,"type":22},1612,[60],"The purpose of this study is to understand brain function, how people make decisions when they interact with others, and how brain function and behavior relate to personality traits.",[342,343,27,344],"Social Cognition","Personality Disorder","Interpersonal Conflict",[27,346,347,348,349,350,351,352,353],"Multi-informant EMA","Neuroimaging","fMRI","Informant","Multi-method","Ecological Momentary Assessment","Self-report","Longitudinal","2026-08-06",{"date":209,"type":39},{"date":295,"type":22},{"date":358,"type":22},"2031-06-30",{"name":360,"class":78},"University of Pittsburgh",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":223,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":58,"phases":371,"briefSummary":372,"conditions":373,"keywords":380,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":47},"100610142","postpartum-education-via-artificial-intelligence-for-recovery-and-loneliness-a-randomized-controlled-trial-100610142","NCT07223736","Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial","Postpartum Education Via Artificial Intelligence for Recovery and Loneliness (PEARL): A Randomized Controlled Trial","PEARL","Inclusion Criteria:\n\n1. Has the capacity to provide informed consent\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Postpartum persons, aged \\>18 years old\n4. Primiparous\n5. Vaginal or cesarean delivery\n6. English Speaking\n7. Internet access and proficiency of internet access\n8. Access to a smartphone\n9. Postpartum 2-6 weeks\n\nExclusion Criteria:\n\n1. Multiparous\n2. Major neonatal anomaly\n3. Delivery \\\u003C 34 weeks gestational age\n4. Intrauterine fetal demise (IUFD)\n5. Enrollment in any interfering studies\n6. Unanticipated NICU admission\n7. Discharge home without live baby\n8. Surrogates\u002Fgestational carrier\n9. Birthing individuals with baby placed for adoption\n10. Currently pregnant\n11. Psychiatric history requiring psychiatric hospitalization prior to delivery\n12. Other psychiatric conditions needing immediate attention and intervention as determined by study team and\u002For treatment team",{"count":370,"type":22},130,[60],"The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth.\n\nThe main questions this study aims to answer are:\n\n* Does using the chatbot improve postpartum pelvic floor health knowledge?\n* Does using the chatbot help reduce feelings of loneliness during the postpartum period?\n* Does using the chatbot impact pelvic floor symptoms?\n\nResearchers will compare standard postpartum care to standard care plus the chatbot.\n\nParticipants will:\n\nBe assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot.\n\nIf in the chatbot group, participants will receive education and support via the chatbot over a 4-week period.\n\nBoth groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress.\n\nThe chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.",[374,375,207,27,64,376,377,378,379],"Pelvic Floor Disorder","Loneliness","Peritraumatic Distress","Women","Artificial Intelligence (AI)","Chatbot",[381,382,383,132,384,385,386,387,388,389,390,391],"loneliness","postpartum","pelvic floor disorder","depression","peritraumatic distress","artificial intelligence","AI","chatbot","LLM","women","large language model","2026-08-04",{"date":394,"type":39},"2026-08-05",{"date":396,"type":39},"2026-01-08",{"date":398,"type":22},"2026-11-01",{"name":400,"class":78},"University of California, San Diego",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":118,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":58,"phases":410,"briefSummary":411,"conditions":412,"keywords":417,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":47},"100583432","sbir-sttr-family-check-up-online-100583432","NCT06876246","SBIR\u002F STTR Family Check-up Online","A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health","Inclusion Criteria:\n\n* A caregiver must have a child between the ages of 11 and 14 enrolled at a participating school;\n* the caregiver must be the parent or legal guardian of the youth;\n* the caregiver must have a smartphone with text messaging capability and access to email; and\n* the youth must be identified by school providers as needing or being eligible for Tier 2 or Tier 3 supports or services.\n\nExclusion Criteria:\n\n* the caregiver is unable to read in either English or Spanish; or\n* the family is already participating in another study of the University of Oregon's Prevention Science Institute.",{"count":409,"type":22},1270,[60],"The Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students\u002Ffamilies) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.",[27,413,414,415,416],"Parenting Stress","Academic Achievement","Parenting Skills","Behavior Problems",[418,419,132,420,421],"digital health","implementation science","family intervention","school-based intervention","2026-08-03",{"date":394,"type":39},{"date":425,"type":39},"2025-01-20",{"date":427,"type":22},"2027-08-31",{"name":429,"class":78},"University of Oregon",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":118,"sex":17,"minAge":438,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":58,"phases":441,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":47},"100534016","phase-2-mindfulness-assisted-psychedelic-therapy-100534016","NCT06233344","Mindfulness-Assisted Psychedelic Therapy","An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy","MAPT","Eligible participants will be:\n\n* Adults of any race, ethnicity, or gender who are age 25 years or older\n* Have not had formal mindfulness training\n* Have not previously used classic psychedelics\n* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he\u002Fshe consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he\u002Fshe must agree not to do so on the session day.\n* Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.\n* Agree not to take any PRN medications on the mornings of drug sessions\n* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of psilocybin administration.\n* Agree that for one week before the drug session, he\u002Fshe will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n\nParticipants will be excluded if they present with any of the following:\n\n* Prior exposure to formal mindfulness or meditation training\n* Previous use of psilocybin or other psychedelic drugs (LSD, mescaline, DMT\u002Fayahuasca, 5-methoxy-DMT)\n* Current use of tricyclic antidepressants, serotonin reuptake inhibitors, antipsychotics, atypical antipsychotics, monoamine oxidase inhibitors (MAOIs), mood stabilizers (lithium), buspirone, mirtazapine, trazodone, or other drugs that modulate the serotonin system. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.\n* Current use of St. John's Wort or 5-hydroxytryptophan\n* Currently taking psychoactive prescription medication on a regular (e.g., daily) basis\n* Current or lifetime history of schizophrenia, other psychotic disorders, or bipolar I or II disorder; or a first or second degree relative with one of these disorders\n* Current or recent past (within the past 5 years) history of alcohol or drug dependence (other than caffeine or nicotine) or major depressive episode\n* Current or recent suicidal ideation (within the past month) or behavior (within the past 6 months), as assessed by a response of \"yes\" to any of questions in the \"Suicidal Ideation\" or \"Suicidal Behavior\" on the C-SSRS at the eligibility screen or baseline session\n* Current (past two weeks) self-reported risky alcohol use (\\>7 drinks\u002Fweek for women or \\>14 drinks\u002Fweek for men)\n* Current obsessive-compulsive disorder, dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa, or bulimia nervosa\n* Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n* Self-reported use of or positive urine drug screen for amphetamines\u002Fmethamphetamine, opioids, barbiturates, methadone, cocaine, or PCP at the eligibility screen visit or the psilocybin visit\n* Positive breath alcohol test at the eligibility screen visit or the psilocybin visit (BrAC \\> 0.01)\n* Current pregnancy, planned pregnancy in the next 6 months (at phone screen or eligibility screen), positive urine pregnancy test (for participants of childbearing potential) at the eligibility screen or the psilocybin session, or current breastfeeding\n* Unwilling to use a medically-accepted highly effective form of birth control (such as hormonal implants, intrauterine devices (IUDs), hormonal birth control pills, surgical sterility, or other methods deemed highly effective (\\\u003C1% failure rate) by the study physician) during the study (applies to male participants as well as female participants of childbearing potential)\n* Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc greater than 450 msec), artificial heart valve, or TIA in the past year\n* Epilepsy with history of seizures\n* Current unstable medical condition (including uncontrolled or poorly controlled hypertension - resting blood pressure greater than 140 (systolic) or 90 (diastolic) mmHg at the eligibility screening will be reviewed by the study physician and participants with stable hypertension will be asked to follow-up with their primary care physician to initiate appropriate hypertensive treatment prior to proceeding)\n* Diabetes (type 1 or 2) with insulin dependence; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Any other medical condition that may be incompatible with safe exposure to psilocybin\n* Inability to speak English\n* Inability to provide informed consent","25 Years",{"count":440,"type":22},40,[442],"PHASE2","The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is \"Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?\" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires, computerized cognitive tests, and have an EEG (a measure of electrical activity in the brain) and functional MRI of brain if possible. Both groups will also complete 2 follow-up surveys (at \\~8 weeks, and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant.",[27],[446,447,448],"Psychedelic therapy","Psilocybin","Mindfulness",{"date":354,"type":39},{"date":451,"type":39},"2025-07-30",{"date":453,"type":22},"2028-08",{"name":455,"class":78},"University of Southern California",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":58,"phases":466,"briefSummary":467,"conditions":468,"keywords":473,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":47},"100649722","tirzepatide-impact-assessment-study-100649722","NCT07740291","Tirzepatide Impact Assessment Study","Tirzepatide Impact Assessment: Exploring Health and Wellness Outcomes","TIA","Inclusion Criteria:\n\n* Age 18 years or older\n* BMI of 27.5 kg\u002Fm2 or higher\n* For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider\n* For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months\n\nExclusion Criteria:\n\n* Pregnant\n* Breastfeeding\n* Wears a pacemaker or other internal medical device\n* Chronic kidney disease in the past 2 years\n* Active cancer or cancer treatment within the past 6 months\n* Current diagnosis of any major endocrine, inflammatory, cardiovascular, or neurological disorder\u002Fcondition, including Addison's disease, autism, congestive heart failure, Crohn's disease, Cushing's syndrome, hyperparathyroidism, multiple sclerosis, neuromuscular disorders (Guillain-Barre syndrome or myasthenia gravis), stroke, thyroid gland disorders (hyperthyroidism or hypothyroidism), type 1 diabetes, and ulcerative colitis\n* Insulin therapy for type 2 diabetes\n* For LS comparator arm only: initiating any weight-loss medication (including a GLP-1 receptor agonist) currently or within the past 3 months",{"count":465,"type":22},27,[60],"This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months.\n\nAt each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study.\n\nThe main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas.\n\nWho can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications.\n\nWho cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.",[469,470,471,472,27],"Obesity & Overweight","Cardiometabolic Health Indicators","Addiction","Eating Disorders",[474,475,476,477,478,479,480,481,482,132],"GLP-1 receptor agonists","obesity","Multi-omics profiling","Semaglutide","Tirzepatide","Appetite Regulation","Addictive Behaviors","eating disorders","appetite-related hormones","2026-07-28",{"date":485,"type":39},"2026-07-31",{"date":487,"type":39},"2025-01-02",{"date":489,"type":22},"2026-12-07",{"name":491,"class":78},"Texas Tech University",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":58,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":47},"100649504","improv-comedy-to-reduce-anxiety-and-improve-mental-well-being-in-young-chinese-adults-in-hong-kong-100649504","NCT07737821","Improv Comedy to Reduce Anxiety and Improve Mental Well-Being in Young Chinese Adults in Hong Kong","An Improv Comedy Intervention to Reduce Anxiety and Enhance Mental Well-Being in Chinese Emerging Adults in Hong Kong: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Ethnic Chinese, fluent in spoken Mandarin and able to read Chinese\n* Never married and without children\n* No current or past diagnosis of any mental disorder (e.g. anxiety disorders, depressive disorders, bipolar disorder, psychotic disorders)\n* Mild to moderate anxiety symptoms (defined as a GAD-7 total score between 5 and 14)\n* No prior experience of formal performance training in drama\n* Availability to attend at least 3 out of 4 weekly sessions over the 4-week intervention period upon enrolment\n\nExclusion Criteria:\n\n* Unstable or severe chronic physical illness that would contraindicate participation in group activities or light-to-moderate physical movement (e.g., uncontrolled hypertension, severe asthma, acute cardiovascular events within the past 6 months)\n* Moderately severe to severe depression symptoms (defined as a PHQ-9 total score greater than 14)\n* Suicidal ideation (defined as a score greater than 0 on item 9 of the PHQ-9)\n* Potential risky drinking behavior (defined as AUDIT-C total score greater than 4)","29 Years",{"count":501,"type":22},150,[60],"The goal of this clinical trial is to learn if improv comedy helps reduce anxiety symptoms and improve mental well-being in Chinese young adults in Hong Kong. The main questions it aims to answer are:\n\n1. Does improv comedy reduce anxiety symptoms?\n2. Does improv comedy improve mental well-being?\n\nResearchers will compare participants who join the improv comedy workshops to participants who are placed on a waiting list to receive the workshops later, to see if improv comedy reduces anxiety and improves mental well-being.\n\nParticipants will:\n\n1. Attend weekly three-hour improv comedy workshops for 4 consecutive weeks\n2. Complete four assessments and brief reflections during or around the workshop sessions\n3. Take part in up to two individual interviews (optional)",[65,27],{"date":506,"type":39},"2026-07-30",{"date":508,"type":22},"2026-08-15",{"date":510,"type":22},"2028-08-31",{"name":512,"class":78},"The University of Hong Kong",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":118,"sex":17,"minAge":521,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":58,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100630996","a-mentalization-based-prevention-program-to-foster-well-being-and-mental-health-in-pre-adolescent-children-and-their-families-100630996","NCT07494929","A Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families","Foster Long-term Well-being in Pre-adolescent Children and Their Families","FLOW","Inclusion Criteria:\n\n* Children: Age range 8 to 11 year olds\n* All participants: Sufficient language knowledge (self-reported)\n\nExclusion Criteria:\n\n* Children: Missing consent forms from all guardians\n* Datasets that indicate random answer patterns or non-engaged responding","8 Years",{"count":523,"type":22},15200,[60],"The FLOW project involves the implementation and rigorous evaluation of an evidence-based, multi-level mentalization prevention program targeting social and psychological determinants of well-being in four European countries (Germany, Lithuania, Spain, and Switzerland). Prevention programs will be tailored to the needs of 8-10 year old children in elementary schools and their parents. All children will participate in a project day focused on mental health. Parents will either attend one of two parent trainings of varying lengths or receive a parenting guidebook. A total of 5,000 children, along with their teachers and parents, are included in the survey. To measure long-term effects, surveys are conducted over the course of a whole year.\n\nThe project examines the following hypotheses:\n\nPrimary hypotheses:\n\nA multilevel mentalization based prevention program will lead to significantly greater improvements in well-being and mental health among children and parents compared to control groups, as measured at the post-intervention assessment.\n\nSecondary hypotheses:\n\n1. A universal prevention program on mental health enhances help-seeking behavior and reduces mental health stigma among children, parents and teachers at post and follow-up measurement.\n2. A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement.\n3. A multi-level mentalization based prevention program leads to greater improvements in well-being and mental health among children and parents than control groups, as measured at follow-up.\n4. A multi-level mentalization based prevention program leads to greater improvements in parental efficacy and family adjustment in parents and reduces parental stress compared to control groups at post and follow-up measurement.\n5. The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.",[27,96],[528,529,530,531,532,27,533],"Randomized Control Trial","Parent trainings","Mentalization","Well-Being","Primary school","Prevention",{"date":506,"type":39},{"date":536,"type":39},"2026-04-14",{"date":538,"type":22},"2028-03",{"name":540,"class":78},"Svenja Taubner",4,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":548,"maxAge":18,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":47},"100627954","mechanisms-and-outcomes-of-children-and-adolescent-psychotherapy-100627954","NCT07455344","Mechanisms and Outcomes of Children and Adolescent Psychotherapy","Study 1\n\nInclusion Criteria:\n\n* Children and their mothers are members of Clalit Health Services.\n* Children and adolescents who received outpatient psychotherapy.\n* Aged 6-18 years at the start of psychotherapy.\n\nExclusion Criteria:\n\n* Psychiatric hospitalization during the course of psychotherapy.\n* Mothers who are not members of Clalit Health Services.\n\nStudy 2\n\nInclusion Criteria:\n\n* Children and their caregivers receiving treatment at the Crisis Intervention Unit at Shalvata Mental Health Center (MHC).\n* Therapists who hold a professional license to practice psychotherapy.\n* Therapists providing psychotherapy in the Child and Adolescent Clinic at Shalvata MHC.\n\nExclusion Criteria:\n\n* Patients and caregivers who are unable or unwilling to provide informed consent.\n* Patients who are at immediate risk, as determined by the treating physician.","6 Years",{"count":550,"type":22},30000,"Since October 7th 2023, Israel's population has been forced to engage in a multi-regional war which affected most of the citizens of Israel. One of the most sensitive populations to be affected by the horrifying events are children and adolescents. In a meta-analysis summarizing the results of 20 studies encompassing a total of 26,302 children and adolescents, the authors reported a significant association between the degree of exposure to traumatic events and psychological distress. Furthermore, a recent study conducted in Ukraine during Russia's invasion indicated an increase in internalizing symptoms among children and adolescents, as reported by parents. Nevertheless, to date, no study has evaluated the extent of distress, and overall mental and physical consequences among children and their parents, in the context of the October 7th events.\n\nOne of the main routes to provide care to children and adolescents inflicted by the consequences of war is through psychotherapy. Although psychotherapy is considered an effective treatment for children and adolescents, studies indicate that dropout rates among this population is as high as 45%. Several predictors were previously offered to be associated with children and adolescents' dropout and psychotherapy outcomes. These predictors can be broadly categorized into two conceptual dimensions. The first is pre-treatment variables that are associated with both children and their parents, such as demographics (i.e., ethnicity, gender, age), diagnosis (including classification and co-morbidity), symptom severity, family characteristics, and parental problems and difficulties. The second dimension is related to within-therapy factors, such as patients' expectations and the quality of mutual work with the therapist. Nonetheless, to date, no systematic study has assessed pre-treatment and within-treatment predictors of dropout and outcome in general or in the context of political conflict.\n\nResearch Objectives\n\nThis study aims to address current gaps in the literature by assessing the effects of October 7th events on parents, children, and adolescents. Furthermore, the study aims to assess the effects of psychotherapy provided in the settings of crisis intervention and treatment as usual in outpatient clinics to children following the war. Research objectives will be addressed using two methodological approaches: a retrospective big-data strategy exploration, and a prospective assessment of ongoing psychotherapies. Based on the reviewed literature, the following research hypotheses will be investigated:\n\n1. Parental psychopathology will mediate the association between traumatic exposure during war and their child's mental and physical health.\n2. Dropout rates from psychotherapy in Israel will be found as similar to those reported in a previous meta-analysis (\\~45%).\n3. Within-treatment variables will have a stronger association with dropout risk and outcome, compared to pre-treatment variables.",[27],[554,555,556,557],"Child and Adolescent Psychotherapy","Dropout","Mechanisms and Outcomes","parental mental health",{"date":559,"type":39},"2026-07-29",{"date":561,"type":39},"2025-01-05",{"date":563,"type":22},"2028-01-30",{"name":565,"class":78},"Shalvata Mental Health Center",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":58,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":593},"100629114","the-mouth-matters-in-mental-health-trial--2-100629114","NCT07470437","The Mouth Matters in Mental Health Trial -2","A Link Work Intervention to Support Dental Visiting in People With Severe Mental Health Difficulties: The Mouth Matters in Mental Health Effectiveness and Cost-Effectiveness Trial","Inclusion Criteria:\n\n* Aged ≥18 years.\n* Receipt of care from community mental health or early intervention teams at the point of referral.\n* No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. Emergency dental care (e.g. emergency attendance at an Accident \\& Emergency Appointment or a dental hospital) is not included within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.\n* Able to provide informed consent as determined by trained researchers in consultation with the clinical team.\n\nExclusion Criteria:\n\n* Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community.\n* Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and\u002For the referrer in approximately one-months' time to determine if risk has subsided to a point where they are now eligible.\n* Enrolled in another dental randomised controlled trial.",{"count":574,"type":22},480,[60],"This clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life.\n\nThe main predictions are that:\n\n1. The link work intervention plus treatment as usual will lead to greater likelihood of attendance at a routine dental appointment, compared with treatment as usual alone.\n2. The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone.\n3. The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.",[27,578,579],"Oral Health Care","Psychosis",[581,582,132],"Mouth Matters","Dentistry","2026-07-24",{"date":585,"type":39},"2026-07-27",{"date":587,"type":39},"2026-05-01",{"date":589,"type":22},"2029-07-31",{"name":591,"class":592},"Lancashire and South Cumbria NHS Foundation Trust","NETWORK",5,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":603,"conditions":604,"keywords":606,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":614,"locationsCount":617},"100648794","patient-empowerment-project-pep-study-100648794","NCT07725458","Patient Empowerment Project (PEP) Study","Efficacy of an Infertility Patient Empowerment Project (PEP), a Pilot Study","PEP","Patients seeking fertility treatment at participating clinics",{"count":253,"type":22},"The Patient Empowerment Project (PEP) will be integrated into the intake process at a fertility clinic to prepare clinical staff for any patient sensitivities or preferences and provide extra support if needed. The study will evaluate if the PEP increases patient retention and patient satisfaction scores.",[605,27],"Infertility",[605,607,608],"Mental health","Assistive Reproductive Technology","2026-07-23",{"date":585,"type":39},{"date":612,"type":22},"2026-08",{"date":168,"type":22},{"name":615,"class":616},"Inception Fertility Research Institute, LLC","INDUSTRY",2,{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":58,"phases":626,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":635,"leadSponsor":637,"locationsCount":47},"100647545","nurse-led-digital-cognitive-behavioral-therapy-for-insomnia-dcbt-i-in-university-students-with-mild-to-moderate-mental-health-problems-100647545","NCT07711769","Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems","Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.\n* Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and\u002For a PHQ-9 score of 5-14 at baseline.\n* Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.\n* Reporting a self-reported sleep efficiency of less than 85% over the past month.\n* Able to communicate in Chinese.\n\nExclusion Criteria:\n\n* Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder\n* Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months\n* Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional\n* Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.",{"count":253,"type":22},[60],"This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.",[27],[630,631,391,388,632],"Cognitive Behavioral Therapy for Insomnia","insomnia","university student",{"date":583,"type":39},{"date":295,"type":22},{"date":636,"type":22},"2027-10-31",{"name":512,"class":78},{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":118,"sex":17,"minAge":645,"maxAge":18,"enrollmentInfo":646,"targetDuration":4,"studyType":58,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":656,"locationsCount":47},"100585625","evaluation-of-the-gambling-habits-of-adolescents-and-young-adults-post-covid-19-and-implementation-of-a-digital-escape-room-intervention-for-preventing-gambling-in-high-school-students-100585625","NCT06904794","Evaluation of the Gambling Habits of Adolescents and Young Adults Post-COVID-19 and Implementation of a Digital Escape Room Intervention for Preventing Gambling in High School Students","Evaluation of the Gambling Habits of Adolescents and Young Adults Post-COVID-19 and Implementation of a Digital Escape Room Intervention for Preventing Gambling in High School Students: a Mixed-methods Cluster-randomized Controlled Trial (GAMBL-OUT Project)","Inclusion Criteria:\n\n* Only high school students aged between 16 and 18\n* Being able to read and understand the Spanish language\n* Willingness to participate in the study and sign the written informed consent form\n\nExclusion Criteria:\n\n* Age: \\\u003C16 years old, or \\>18 years old","16 Years",{"count":647,"type":22},240,[60],"Gambling behaviors among adolescents and young adults have been experiencing an upward trend in the last years, possibly because of new habits developed during the COVID-19 lockdown restrictions. Different preventive strategies have been proposed: universal classroom-based interventions have shown promising evidence as preventive tools, but challenges exist in engaging the target audience effectively. Serious games, i.e., those designed with the specific intent to educate, broaden knowledge, and change behaviors, have been tested with positive outcomes. Digital escape rooms constitute a modality of serious game that has shown potential for a variety of educational purposes, but their efficacy for preventing addictive behaviors, as well as their long-term impact, has not been widely studied.\n\nThe present project aims at assessing the gambling habits of a sample of 16-25-year-olds in the region of Aragon, Spain, that could be compared to the data gathered before the pandemic started, so not only the prevalence rates can be updated but also potential differences in habits (e.g., preferred gambling alternatives) can be detected. This will undoubtedly help the design of effective preventive measures, such as the GAMBL-OUT digital escape room, a serious game to be implemented in high schools with the aim of increasing knowledge, reducing intentions to gamble, and changing attitudes towards gambling.",[27],"2026-07-22",{"date":609,"type":39},{"date":654,"type":39},"2025-04-02",{"date":241,"type":22},{"name":657,"class":78},"Hospital Miguel Servet",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":665,"enrollmentInfo":666,"targetDuration":4,"studyType":58,"phases":668,"briefSummary":669,"conditions":670,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":617},"100628816","testing-multi-level-scale-up-strategies-ugandan-school-system-100628816","NCT07466563","Testing Multi-level Scale-Up Strategies: Ugandan School System","TESTING MULTI-LEVEL SCALE-UP STRATEGIES TO IMPLEMENT A SCHOOL-BASED POPULATION APPROACH OF MENTAL HEALTH PREVENTIVE INTERVENTION: UGANDA","Inclusion Criteria:\n\nTTCs and tutors:\n\n* 12 TTCs (out of a total 26 TTCs) will be selected.\n* All tutors will be aged 18-65, and currently employed under the educational system.\n* Tutors from each TTC will be recruited and trained in EBI implementation and management\n\nSchools:\n\n* 10 public schools (5 match pairs, match in size) under each TTC will be selected, and Principals of public schools will be invited to attend information sessions.\n* All principals will be aged 18-65, and currently employed under the educational system.\n\nPTTs and teachers:\n\n* All pre-primary teachers serving students between the ages of 3 and 12 years at the 120 study schools will be eligible to participate.\n* All teachers will be aged 18-65, and currently employed under the educational system.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Teachers who are not teaching students in the selected schools or not within the TTC service region.","65 Years",{"count":667,"type":22},1536,[60],"The overall objective of the project is to address the school mental health evidence-based interventions (EBIs) scale-up and sustainability challenges in low-and-middle-income countries (LMICs) by studying \"system level intervention\" strategies. The project tests a scale-up model utilizing a two-level train-the-trainer model to support the expansion of an evidence-based intervention (mWEL -Teacher Professional Development; PD) in one LMIC (Uganda). mWEL-PD is the abbreviation of \"Promoting Mental Wellbeing \\& Empowering Lives of the School Community\". mWEL -PD is a teacher intervention that trains teachers to apply evidence-based strategies to engage parents and to promote student's mental health in classroom, as well as to promote teachers' own mental wellbeing. PD has been adapted and tested in Uganda and has demonstrated effectiveness in promoting Ugandan teachers' practices, teacher wellbeing, and students' mental health. Previous studies only applied one-level of the train-the-trainer model. This new study will test a new two-level of the train-the-trainer model that include a digital-learning system to scale PD, so that more teachers can be trained on PD, and more students can benefit from teachers' training and practice changes. Investigators will also test the new EBI\u002FPD scale-up model with and without including additional sustainability strategies (including technical assistance and continuing education strategies). Investigators will carry out an evaluation study (using a cluster-randomized trial design) to understand the impacts of the new two-level training model. The participants of the study will be the trainers and trainees, and the outcomes will be their implementation and practice outcomes.",[27],"2026-07-21",{"date":651,"type":39},{"date":674,"type":39},"2026-03-03",{"date":676,"type":22},"2029-03-31",{"name":678,"class":78},"NYU Langone Health",{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":118,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":686,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":688,"conditions":689,"keywords":693,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":697,"startDateStruct":698,"completionDateStruct":699,"leadSponsor":700,"locationsCount":47},"100648603","university-survey-on-consumer-behavior-and-mental-health-100648603","NCT07721896","University Survey on Consumer Behavior and Mental Health","UCCSAM","Inclusion Criteria:\n\n* aged 18 years and older\n* Hospital teachers (including CCA-AHU, MCU-PH, PU-PH, and PHU) at the Faculty of Medicine of Strasbourg.\n* Medical students in their 2nd cycle (including midwives) at the Faculty of Medicine of Strasbourg.\n* Medical students in their 3rd cycle at the Faculty of Medicine of Strasbourg.\n\nExclusion Criteria:\n\nN\u002FA",{"count":687,"type":22},245,"This university research study investigate consumption behaviors among medical students, midwifery students, and academic hospital staff, including the use of substances, medications, and digital media. The study seeks to examine how these behaviors are associated with mental health, stress, and social or academic factors. Through an anonymous online questionnaire, the research aims to identify patterns and potential risk factors in order to better understand the needs of these populations and support the development of appropriate prevention and support strategies.",[690,27,691,692],"Consumer Behavior","Consumption","Stress and Anxiety",[132,694,695,696,234],"Psychological Stress","Behavior, Addictive","Surveys and Questionnaires",{"date":609,"type":39},{"date":295,"type":22},{"date":398,"type":22},{"name":701,"class":78},"University Hospital, Strasbourg, France"]