[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mental-health-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mental-health-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,71,105,137,162,193,224,248,279,305,328,378,425,450],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100553732","overview-of-the-mental-health-of-adolescents-in-therapeutci-educational-and-pedagogical-facilities-in-france-100553732",false,"NCT06489912","Overview of the Mental Health of Adolescents in Therapeutci, Educational and Pedagogical Facilities in France","Etat Des Lieux de la santé Mentale Des Adolescents Suivis Par Les Dispositifs ITEP en France","PsyPreDi","Inclusion Criteria:\n\n* Adolescent aged 12 to 16\n* In a DITEP for at least 15 days\n* Minor who has been informed and has not objected to the research (according to his\u002Fher capacity)\n* At least one person exercising parental authority who has read and understood the information note and has not objected to the research OR\n* For a minor under guardianship: legal representative who has read and understood the information note and has not objected to the research.\n\nExclusion Criteria:\n\n* Minor and\u002For person(s) exercising parental authority who do not understand French\n* Holder of parental authority opposed to the search\n* Minor opposed to search",true,"ALL","12 Years","16 Years",{"count":22,"type":23},200,"ESTIMATED","OBSERVATIONAL","Assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.",[27],"Mental Health Disorder","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2024-12-20",{"date":36,"type":23},"2026-12-31",{"name":38,"class":39},"University Hospital, Rouen","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100449909","supporting-treatment-access-and-recovery-in-cod-100449909","NCT05138614","Supporting Treatment Access and Recovery in COD","Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders","STAR-COD","Inclusion Criteria:\n\n* Are 18 years-old and older;\n* Are fluent in English or Spanish;\n* Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;\n* Able to provide consent;\n* Potentially have a concurrent substance use disorder in addition to opioids; and\n* Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and\u002For schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and\u002For schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for \"a\" (i.e., not having a substance use relapse), but they do meet criteria for \"b\" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria.\n\nExclusion Criteria:\n\n* Are not fluent in English or Spanish;\n* Are acutely psychotic, acutely suicidal with a plan, or homicidal;\n* Are incompetent and unable to provide informed consent; and\n* Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of \\> 10 mg\u002Fday; Diazepam \\> 100 mg\u002Fday; Clonazepam 5 mg\u002F day; Alprazolam 5 mg\u002Fday.","18 Years",{"count":51,"type":23},1000,"INTERVENTIONAL",[54],"NA","This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.",[57,27],"Opioid Use Disorder",[59,60],"opioid use disorder","mental health","2026-06-02",{"date":63,"type":32},"2026-06-04",{"date":65,"type":32},"2022-03-11",{"date":67,"type":23},"2026-08-31",{"name":69,"class":39},"University of Massachusetts, Worcester",5,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":52,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100634865","digital-lifestyle-intervention-for-mental-health-among-migrants-randomized-controlled-trial-100634865","NCT07545239","Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial","Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study","LIFT-RCT","Inclusion Criteria:\n\n* Migrant living in Sweden\n* Age 18 years or older\n* Moderate psychological distress (PHQ-9 ≥10, GAD-7 ≥10, or PSS-4 ≥8)\n* Ability to read and write in easy Swedish or English\n* Access to a computer or device with internet connection\n* Motivation to engage in lifestyle change\n* Ability to provide digital informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric disorder\n* Severe depression or suicide risk\n* Severe medical illness\n* Alcohol dependency\n* Initiation or adjustment of psychotropic medication within the last 8 weeks",{"count":80,"type":23},240,[54],"Migrant populations experience elevated levels of psychological distress while facing barriers to accessing mental health care. Lifestyle factors such as physical activity, sleep, diet, and social engagement are closely linked to mental health and represent promising targets for preventive interventions. Digital delivery may increase accessibility and reduce structural barriers to care.\n\nThe aim of this study is to evaluate the feasibility, acceptability, and efficacy of a culturally and linguistically adapted digital lifestyle intervention for migrants experiencing moderate psychological distress in Sweden. Participants (N = 240) will be randomized to an 8-week digital lifestyle intervention or to a wait-list control receiving a general lifestyle module. A nested pilot study (N = 30) will first assess feasibility and acceptability.\n\nOutcomes include general psychological health, quality of life, depression, anxiety, stress, and lifestyle behaviors. Assessments will be conducted at baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up.",[27,84,85,86],"Depression","Anxiety","Psychological Distress",[88,89,90,91,92,93,94],"Migrant mental health","Lifestyle intervention","Digital intervention","Prevention","Randomized controlled trial","CBT","Public health","NOT_YET_RECRUITING","2026-04-16",{"date":98,"type":32},"2026-04-22",{"date":100,"type":23},"2026-04",{"date":102,"type":23},"2028-10",{"name":104,"class":39},"Karolinska Institutet",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":52,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"100616716","employing-peer-outreach-and-whole-health-in-recovery-for-homeless-experienced-veterans-100616716","NCT07309224","Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans","Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (QUE 25-014)","EMPOWER","Inclusion Criteria:\n\n* Eligible patients will be identified from VA's Homeless Registry \"Hot Spot\" reports, which use real-time data on acute care service utilization to identify high-need, housing-insecure patients.\n* These reports identify Veterans on the VA Homeless Registry (i.e., those who had received VA housing services in the past two years) who had \\>1 hospital admissions and\u002For \\>2 ED visits in the past quarter of the fiscal year.\n* From these reports, the investigators will identify patients at each implementation site who are\n\n  * (a) currently enrolled in HUD-VASH\n  * (b) have a mental health and\u002For SUD diagnosis\n\nExclusion Criteria:\n\n* Not flagged on the VA's Homeless Registry Hot Spot Report\n* Not currently enrolled in HUD-VASH\n* Does not have a mental health and\u002For substance use disorder diagnosis\n* Is not a patient at a participating site of the implementation trial",{"count":114,"type":23},278,[54],"Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced veterans in permanent supportive housing.",[118,27,119],"Substance Use Disorder","Homelessness",[121,122,123,124,125],"Veterans","Homeless Persons","Peer Influence","Whole Person Health","Implementation Science","2026-04-08",{"date":128,"type":32},"2026-04-09",{"date":130,"type":23},"2026-07-01",{"date":132,"type":23},"2030-09-30",{"name":134,"class":135},"VA Office of Research and Development","FED",1,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":52,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":136},"100493078","enhancing-wellness-through-affirming-services-and-education-100493078","NCT05700474","Enhancing Wellness Through Affirming Services and Education","EASE","Inclusion Criteria:\n\n1. HIV diagnosis or seeking HIV prevention services\n2. Any alcohol or illicit substance use in the last 90 days\n3. 18 or older\n4. Residing in Mecklenburg County or surrounding areas.\n\nExclusion Criteria:\n\n1\\) Inability to consent for services due to reduced mental or physical capacity",{"count":22,"type":23},[54],"The goal of this treatment study is to learn about the mental health, substance use and physical health outcomes associated with participating in the EASE holistic behavioral health and wellness program for individuals seeking HIV prevention and\u002For living with HIV. The main questions it aims to answer are:\n\n1. Do important health outcomes, including substance use, mental health and social support related outcomes of individuals who participated in the holistic behavioral health and wellness program change after study participation?\n2. Does a tailored approach to meet the specific needs of different subpopulations including 1) older (40+) PLWH with or at risk for additional health comorbidities and 2) PLWH and\u002For young adults (18-40) seeking HIV prevention to improve health outcomes including improvement in health and health behaviors .\n\nParticipants will be asked to:\n\n* participate in 6 months of behavioral health treatment tailored to their needs, which may include individual counseling, group counseling, case management, peer support, and related education.\n* Complete surveys at the time of study entry and 6 months later to measure changes in health outcomes over time.",[148,27,149],"HIV","Substance Use",[148,151,149,152,153],"Mental Health","PrEP","Comorbidity","2026-04-06",{"date":128,"type":32},{"date":157,"type":32},"2023-02-13",{"date":159,"type":23},"2027-07-01",{"name":161,"class":39},"Duke University",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":18,"minAge":169,"maxAge":49,"enrollmentInfo":170,"targetDuration":4,"studyType":52,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":136},"100509962","a-digitally-assisted-risk-reduction-platform-for-youth-at-high-risk-for-suicide-100509962","NCT05920252","A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide","Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide","Inclusion Criteria:\n\n* Written informed assent from adolescents ages 13-17 years old and permission from legal guardians, or consent from adolescents age 18 years old.\n* Receiving treatment at the Intensive Adolescent and Family DBT Pgogram\n* 13-18 years old\n* Owns a personal smartphone (Android or iPhone 7+)\n* Fluent in English\n\nExclusion Criteria:\n\n* Adolescents who require a higher level of care (i.e., are not admitted to the Intensive Outpatient DBT program)\n* Adolescents who are receiving treatment at the Intensive Adolescent and Family DBT program and have already been assigned a clinician","13 Years",{"count":171,"type":23},78,[54],"Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.",[175,27,176],"Suicide","Anhedonia",[84,178,179,180,181,182,183],"Depressive Disorder","Mood Disorders","Mental Disorders","Suicidal Behaviors","Suicidal Thoughts","Suicidal Ideation","2026-03-02",{"date":186,"type":32},"2026-03-04",{"date":188,"type":32},"2024-08-14",{"date":36,"type":23},{"name":191,"class":192},"Ksana Health","INDUSTRY",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":18,"minAge":169,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":52,"phases":204,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100619749","a-just-in-time-adaptive-intervention-for-suicide-safety-planning-in-adolescents-100619749","NCT07348666","A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents","BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents (ViraSafe RCT (SBIR Phase 2))","ViraSafeRCT","Inclusion Criteria:\n\nYouth (minors):\n\n* 13-17 years old\n* Suicide attempt in the last year and ideation in the past month\n* English fluency and literacy\n* Parent or legal guardian willing and able to legally provide informed consent\n* Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan\n\nYouth (adults)\n\n* 18-24 years old\n* Recent suicide attempt or ideation with a plan\n* English fluency and literacy\n* Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan.\n\nExclusion Criteria:\n\nYouth (minors):\n\n* Unable to read\u002Funderstand English\n* Current manic or psychotic episode\n* Development disability precluding comprehension of study procedures\n* No routine access to a mobile phone, assessed by EHR review and during phone screen\n* No eligible parent or legal guardian to provide informed consent\n\nYouth (adults):\n\n* Unable to read\u002Funderstand English\n* Current manic or psychotic episode\n* Development disability precluding comprehension of study procedures\n* No routine access to a mobile phone, assessed by EHR review and during phone screen","24 Years",{"count":203,"type":23},100,[54],"Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.",[175,27,176],[208,209,210,211,212,213,214],"depression","depressive disorder","mood disorder","mental disorders","suicidal behavior","suicidal thoughts","suicidal ideation","2026-01-29",{"date":217,"type":32},"2026-02-02",{"date":219,"type":23},"2026-02-16",{"date":221,"type":23},"2027-12-31",{"name":191,"class":192},3,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":136},"100615970","police-officers-mental-health-and-occupational-health-monitoring-100615970","NCT07299526","Police Officers' Mental Health and Occupational Health Monitoring","Mental Health Difficulties Among Police Officers. Practices of Occupational Health Physicians and Nurses for Identifying and Referring Them to Specialized Care in France","PAST","Inclusion Criteria:\n\n* Be an occupational physician or occupational health nurse and work with a team of national police officers,\n* Agree to participate in the study,\n\nExclusion Criteria:\n\n* Have been employed by the Ministry of the Interior for less than 6 months","64 Years",{"count":22,"type":23},"Police officers are subject to various occupational risk factors that can contribute to the development of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. A previous study observed a low rate of access to specialized care services. Furthermore, carrying a firearm can facilitate acts of self-harm.",[27],[27,237,238],"Police officers","Occupational Health","2025-12-09",{"date":241,"type":32},"2025-12-23",{"date":243,"type":32},"2025-07-04",{"date":245,"type":23},"2026-07-04",{"name":247,"class":39},"University Hospital, Strasbourg, France",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":52,"phases":258,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100604539","efficacy-of-the-i-care-digital-health-intervention-100604539","NCT07150832","Efficacy of the I-CARE Digital Health Intervention","I-CARE: Efficacy of a Digital Health Intervention to Reduce Suicidal Ideation During Psychiatric Boarding","Inclusion Criteria:\n\n* Adolescents of any sex and gender, aged 12-17 years at ED visit or hospital encounter\n* Presenting with suicide attempt or ideation, or self-harm\n* Medically stable\n* English-speaking\n* Awaiting transfer for inpatient psychiatric care or disposition.\n\nExclusion Criteria:\n\n* Cognitive or developmental delays precluding participation (intellectual functioning \\\u003C12 years of age)\n* Behavioral limitations that preclude program participation\n* Active psychosis\n* Legal parent\u002Fcaregiver unable to speak English or unavailable to provide consent (e.g. Wards of the State)","17 Years",{"count":257,"type":23},173,[54],"When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience \"boarding\", which is defined by the Joint Commission as \"the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made.\" A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3\n\nI-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.",[27,261,183,262],"Suicide Attempt","Emergency Psychiatric",[264,265,266,267,268],"Children","Adolescents","Emergency Department","Mental Health Boarding","Psychosocial Skills","2025-10-29",{"date":271,"type":32},"2025-10-31",{"date":273,"type":32},"2025-10-06",{"date":275,"type":23},"2027-06-30",{"name":277,"class":39},"Dartmouth-Hitchcock Medical Center",4,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":52,"phases":288,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":136},"100597135","engaging-mental-health-services-for-preschoolers-at-risk-100597135","NCT07054554","Engaging Mental Health Services for Preschoolers at Risk","NTRI-MH","Inclusion Criteria:\n\n* Family Navigators: Having experience working as family navigator and\u002For community health worker; Latinx, Black or White; \\> 18 years old.\n* Caregivers: current caregiver of a HStart preschooler at-risk for MH disorders (ASQ-SE above threshold score)\n* Teachers: Current Head Start (HStart) teacher from one of the 2 HStart site;\\> 18 years old; Any race\u002Fethnicity.\n* PCPs: Currently providing primary care for HStart preschool age children at risk for MH disorders; \\> 18 years old; Any race\u002Fethnicity.\n\nExclusion Criteria:\n\n* Unable to read\u002Fspeak either English or Spanish.",{"count":287,"type":23},106,[54],"Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and PCP stakeholders to adapt NTRI-MH and created a web-based dashboard to monitor outcomes (Phase 1). Then, for phase 2, the investigators will conduct a feasibility study for caregivers of HStart preschoolers with MH symptoms, guided by ethno-racially matched family navigators and referrals by HStart teachers and PCPs (n=20). Further, for Aim 2, the investigators will pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group of caregivers who receive child behavior training (n=86). The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child emotion regulation. If the aims of the project are achieved, this study would have a large impact on early MH service use for ethno-racial minoritized young children with the potential to improve child MH outcomes.",[27,291,292,293],"Family Navigation","Minoritized Population","Preschool Age Children",[291,295,293],"mental health disorder","2025-08-19",{"date":298,"type":32},"2025-08-24",{"date":300,"type":32},"2025-07-01",{"date":302,"type":23},"2027-07-31",{"name":304,"class":39},"Children's Hospital Medical Center, Cincinnati",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":52,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":223},"100601776","virtual-reality-for-vocational-recovery-100601776","NCT07114887","Virtual Reality for Vocational Recovery","Enhancing Vocational Support With a Virtual Reality Vocational Skills Building Application: Piloting VR4VR","VR4VR","A young person participant will be considered eligible for inclusion in this study if:\n\n1. They are aged 18-25 seeking vocational support at participating vocational support programs\n2. Have a named care-coordinator or key worker\n3. Comfortable using a VR headset\n4. Consent to recording of interview for transcription\n\nExclusion Criteria:\n\n1. They lack fluency in English (spoken and written), since this is required to understand participate in the VR intervention;\n2. They have a known diagnosis of a moderate intellectual disability, due to some of the content delivered during the intervention requiring a certain level of understanding.\n3. As the therapy uses audio and visual means of communication, participants with impairments so severe that they cannot hear instructions, or are unable to see the virtual reality environments, cannot participate. Mild impairments can be accommodated, as sound volume can be turned up, and the Meta Quest headband is used to comfortably use glasses with the headset.\n\nA vocational specialist or staff participant will be considered eligible for inclusion in this study if:\n\n1. Presently work within a vocational program and hold a caseload of young people\n2. Have worked with at least 5 young people within a vocational intervention.\n3. Sufficient command of the English language\n4. Consent to audio recording of interview\n\nNo exclusion criteria\n\nA staff participant will be considered eligible for inclusion in this study if:\n\n1. Presently work within a role supporting a vocational program\n2. Sufficient command of the English language\n3. Consent to audio recording of interview\n\nNo exclusion criteria","25 Years",{"count":315,"type":23},20,[54],"Unemployment is higher among young people who experience mental ill-health compared to the general population. This can have a lasting impact on young people, many of whom are highly motivated to gain employment and education. There are many challenges to seeking, gaining, and maintaining employment for young people. To address these challenges and help young people meet their employment and education goals, investigators have developed a VR intervention to support vocational skill building. The aim of the current study is to evaluate the feasibility, acceptability, and safety, of the Virtual Reality for Vocational Recovery (VR4VR) intervention. A small group of vocational specialists will support up to 20 young people with their vocational outcomes using VR4VR over a 3-6week period. Both young people and specialists will complete questionnaires related to acceptability of the intervention, including qualitative interviews. Data on feasibility and safety will also be collected. Results will inform whether VR is feasible, acceptable, and safe to support vocational outcomes within vocational services that support young people with mental health difficulties, potentially supporting further intervention development and larger trials.",[27],"2025-08-06",{"date":321,"type":32},"2025-08-11",{"date":323,"type":23},"2025-08",{"date":325,"type":23},"2025-12",{"name":327,"class":39},"Orygen",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":336,"minAge":49,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":52,"phases":338,"briefSummary":339,"conditions":340,"keywords":356,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":375,"leadSponsor":376,"locationsCount":136},"100597441","therapeutic-writing-for-adults-suffering-from-chronic-pain-and-comorbid-mental-health-disorders-100597441","NCT07058532","Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders","Therapeutic Writing Intervention in Pain Rehabilitation","TWfCP&MH","Inclusion Criteria:\n\n* Adult women (18 years or older), assigned female at birth and self-identify as women\n* Diagnosed with or experience of chronic, widespread (non-cancer) pain lasting at least two years\n* Diagnosed with or living with one or more mild mental health disorders (e.g., anxiety, mild depression), without current or past severe psychiatric conditions\n* Diagnosed with or experience of nociplastic pain (e.g., fibromyalgia)\n* Not currently using medications that may impair cognitive functioning (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)\n* Able to attend approximately 11 in-person visits over a 3-month period\n* Willing and able to participate in a structured therapeutic writing intervention\n* Purposefully selected to reflect a range of lived experiences relevant to the study's aims\n\nExclusion Criteria:\n\n* Presence of severe mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression, or other psychotic conditions)\n* Use of medications known to impair memory, attention, or decision-making (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)\n* Participation in other concurrent treatments that may influence study outcomes\n* Cognitive limitations that would hinder meaningful engagement in the writing intervention\n* Individuals not assigned female at birth or who do not identify as women","FEMALE",{"count":70,"type":23},[54],"The goal of this observational study is to understand the effects and experiences of therapeutic writing interventions in adult women with chronic pain and co-occurring mental health conditions. The main questions it aims to answer are:\n\nCan therapeutic writing help relieve chronic pain and emotional distress?\n\nHow does writing support emotional processing, regulation, and meaning-making during rehabilitation?\n\nParticipants will take part in a two-part writing intervention involving:\n\nGuided writing exercises that focus on emotional processing, emotion regulation, and creating meaning.\n\nIndividual interviews after the writing sessions to explore their experiences.\n\nThe study uses qualitative analysis methods-phenomenology and logotherapy-to better understand how these writing interventions may support recovery, improve well-being, and offer non-pharmacological tools for managing chronic pain and mental health challenges.",[341,27,342,343,344,345,346,347,348,349,350,351,178,352,353,354,355],"Chronic Pain","Psychiatric &Amp;Amp;or Mood Disorder","Psychiatric Comorbidities","Psychiatric Diagnosis","Emotional Pain","Emotional Distress","Emotion Regulation","Emotional Processing","Meaning of Life","Meaning Made","Meaning of Life and Life Satisfaction","Anxiety Disorders","Sleep Disorder","Comorbid Depression","Process, Acceptance",[357,358,359,360,361,362,363,364,365,366,367,368,369,370],"Therapeutic writing","Chronic pain","Mental health disorders","Psychiatric disorders","Emotion regulation","Emotional processing","Meaning-making","Non-pharmacological intervention","Logotherapy","Phenomenological analysis","Psychosocial rehabilitation","Pain management","Pain coping","Creative writing","2025-06-30",{"date":373,"type":32},"2025-07-10",{"date":323,"type":23},{"date":100,"type":23},{"name":377,"class":39},"Toni Salikka",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":111,"eligibilityCriteria":384,"healthyVolunteers":17,"sex":18,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":388,"conditions":389,"keywords":410,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":136},"100361552","empower-1-a-multi-site-clinical-cohort-research-study-to-reduce-health-inequality-100361552","NCT03987633","EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality","EMPOWER-1: A Multi-site Clinical Cohort Study to Reduce Health Inequality: Identifying Ethnic Disparities in Treatment Failures for Medicines Prescribed to Treat Diseases That Cause Significant Mortality and Morbidity in the UK Population","Inclusion Criteria:\n\n1. Patients or their relative\u002Ffamily member is diagnosed with the illness being investigated by this study.\n2. All NHS patients that are associated with a participating study site, but do not fall under the first bullet point above, may participate with a view that they may potentially contribute to a case control population in the research study.\n3. Subjects agree to:\n\n   1. Gift biological samples, i.e. saliva. Where practical, blood or other biological samples may be voluntarily provided by the patient.\n   2. Provide Consent for access to medical records.\n   3. Complete disease specific, quality of life, and study associated questionnaires.\n\nExclusion Criteria:\n\n1. Patient does not provide a valid consent for study participation.\n2. Patient is not registered with the NHS for care.\n3. Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical research study.\n4. Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with the Mental Health Act 2005.","6 Years",{"count":387,"type":23},200000,"Health inequality and genetic disparity are a significant issue in the United Kingdom (UK).\n\nThis study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations.\n\nThe vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations.\n\nThis large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK.\n\nThe goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.",[390,391,392,393,394,395,396,397,398,399,400,401,402,403,84,404,27,405,406,407,408,409],"Atrial Fibrillation","Coronary Heart Disease","Cardiovascular Diseases","Heart Failure","Hypertension","Peripheral Arterial Disease","Stroke, Ischemic","Asthma","Chronic Obstructive Pulmonary Disease","Obesity","Cancer","Chronic Kidney Diseases","Diabetes Mellitus","Dementia","Epilepsy","Rheumatoid Arthritis","Blood Pressure","Breast Cancer Risk","Prostate Cancer","Lung Cancers",[411,412,413,414,415],"genetic disparity","health inequality","genetics","health outcomes","equality","2025-03-05",{"date":418,"type":32},"2025-03-10",{"date":420,"type":32},"2020-02-01",{"date":422,"type":23},"2030-02-01",{"name":424,"class":39},"Future Genetics Limited",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":17,"sex":336,"minAge":49,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":136},"100396871","bern-birth-cohort--trajectory-of-microbiota-maturation-in-healthy-bern-infants---a-network-approach-100396871","NCT04447742","Bern Birth Cohort \u002F Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach","BeBiCo","Inclusion Criteria:\n\n* Signed informed consent.\n* Ability to understand and follow study procedures and understand informed consent\n* From week 20 of pregnancy until birth\n* General good health, i.e. absence of major severe medical\u002F surgical\u002F psychiatric condition requiring ongoing management. Minor well controlled conditions (e.g. medically controlled arterial hypertension, occupational asthma, gestational diabetes mellitus) may be present.\n* Absence of known severe embryonal pathology, expected normal pregnancy (e.g. minor conditions including twin\u002F triplet pregnancy, final pelvic position may be present)\n* Age 18-45 years.\n\nExclusion Criteria:\n\n• Participation in another clinical study interfering with study procedures.","45 Years",{"count":434,"type":23},250,"Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood.\n\nAims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome.\n\nMethods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps.\n\nSpecies composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content.\n\nExpected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.",[437,438,439,440,27],"Maturation of the Healthy Infant Intestinal Microbiota","Microbial Colonization","Nutrition Disorder, Infant","Milk Expression, Breast","2024-11-11",{"date":443,"type":32},"2024-11-12",{"date":445,"type":32},"2020-05-07",{"date":447,"type":23},"2035-03-03",{"name":449,"class":39},"Insel Gruppe AG, University Hospital Bern",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":52,"phases":460,"briefSummary":461,"conditions":462,"keywords":465,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":136},"100493394","rct-comparing-avatar-intervention-to-supportive-intervention-to-reduce-cannabis-use-in-patients-with-psychotic-disorders-100493394","NCT05704582","RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders","A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders","AC2","Inclusion Criteria:\n\n* Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ;\n* Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).\n\nExclusion Criteria:\n\n* Current SUD for a substance other than cannabis ;\n* Ongoing pharmacological or psychological treatment for CUD ;\n* Ongoing detoxification for cannabis withdrawal ;\n* Presence of neurological disorders ;\n* Presence of a severe and unstable physical illness ;\n* Inability to provide consent.",{"count":459,"type":23},150,[54],"The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.",[463,464,27],"Psychotic Disorders","Cannabis Use Disorder",[466,467,468,469],"cannabis","virtual reality intervention","psychotic disorders","substance use disorders","2024-02-05",{"date":472,"type":32},"2024-02-07",{"date":474,"type":32},"2023-02-01",{"date":476,"type":23},"2028-01",{"name":478,"class":39},"Ciusss de L'Est de l'Île de Montréal"]