[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychosocial-functioning\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychosocial-functioning":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,77,107,130,158,186,213,240,264,292,318,341,365,394,416,452,476],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100513239","development-of-a-transdiagnostic-intervention-for-adolescents-at-risk-for-serious-mental-illness-100513239",false,"NCT05962879","Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness","Inclusion Criteria:\n\n* Currently enrolled in 9th through 12th grade and between the ages of 14 and 19\n* Endorsed at least one psychotic experience\n* Provided contact information\n* Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)\n* Have a parent or legal guardian who is able and willing to participate in a parent session\n* Competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older)\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Currently prescribed psychotropic medication (not including medications for attention deficit\u002Fhyperactivity disorder), regardless of adherence\n* Currently obtaining psychotherapeutic intervention","ALL","14 Years","19 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"NA","This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.",[26,27,28,29],"Anxiety Disorders","Psychotic Disorders","Depressive Disorder","Psychosocial Functioning","RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2024-03-22",{"date":38,"type":20},"2027-05-31",{"name":40,"class":41},"Massachusetts General Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100625583","psychosocial-effects-of-mindfulness-based-exercise-in-postmenopausal-women-100625583","NCT07424521","Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women","The Effects of Mindfulness-Based Exercise on Anxiety, Depression, and Sleep Quality in Postmenopausal Women","Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Being in the early postmenopausal period (no more than 8 years have passed since menopause)\n* Having experienced natural menopause\n* Having had at least one pregnancy\n* Residing in Istanbul or Izmir provinces\n\nExclusion Criteria:\n\n* History of trauma or illness that would prevent exercise\n* Having received hormone replacement therapy\n* Being involved in a different exercise program\n* Presence of a severe cardiopulmonary, orthopedic, or neurological disease\n* Presence of a psychological or psychiatric diagnosis\n* Presence of physical discomforts such as severe dizziness\n* Cooperation problems and incompatibility",true,"FEMALE","45 Years","60 Years",{"count":55,"type":20},20,[23],"Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality.\n\nContinuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.",[29,59,60],"Mindfulness","Postmenopausal Symptoms",[62,63,64,65,66],"mindfulness","postmenopausal","depression","sleep quality","anxiety","NOT_YET_RECRUITING","2026-02-14",{"date":70,"type":34},"2026-02-20",{"date":72,"type":20},"2026-03-01",{"date":74,"type":20},"2026-06-01",{"name":76,"class":41},"Halic University",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":50,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100519456","digital-implementation-support-to-achieve-uptake-and-integration-of-task-shared-care-for-schizophrenia-in-primary-care-in-india-100519456","NCT06043778","Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India","Inclusion Criteria:\n\n* Primary diagnosis of schizophrenia per IDC-10 diagnostic criteria for research and an illness duration of greater than 12 months and overall moderate level of severity on the CGI-SCH scale\n* At least one risk factor for early mortality (e.g. hypertension, diabetes, dyslipidemia, etc)\n* Willingness to stay in the study area during the trial period\n* Ability to operate a smartphone\n\nExclusion Criteria:\n\n* Major visual impairment or inability to operate a smartphone\n* Cognitive impairment or diagnosis of dementia\n* Planning to move out of the study area in the next 12 months\n* Does not speak Hindi or Kannada","18 Years",{"count":85,"type":20},240,[23],"Schizophrenia represents a significant contributor to the global burden of disease, with this burden disproportionately impacting low- and middle-income countries (LMICs). In India, the burden due to schizophrenia is further exacerbated by low access to effective psychosocial interventions aimed at promoting recovery, rehabilitation, and community tenure, as well as inadequate attention to managing co-occurring chronic medical conditions that result in significantly reduced life expectancy among those living with schizophrenia compared to the general population. A major driver of these alarming gaps in access to care for persons with schizophrenia in India is the limited capacity within primary care settings aimed at addressing the complex co-occurring mental health, physical health, and functional needs of this patient population. There now exists strong evidence demonstrating that community programs delivered in primary care and leveraging psychosocial interventions combined with linkage to specialty psychiatric services are effective for supporting treatment and recovery of schizophrenia in low-resource settings. We will leverage our existing collaboration and robust research infrastructure in both rural and urban settings in Madhya Pradesh and Karnataka, India to conduct a hybrid type 1 effectiveness-implementation trial to evaluate whether the use of a digital platform offers added clinical benefit and can support integration of this task shared care for schizophrenia into routine primary care settings. We will address the following aims: 1) evaluate whether the use of the mindLAMP digital platform can enhance the clinical effectiveness of task-shared community-based psychosocial rehabilitation (COPSI) for individuals with schizophrenia, and 2) determine whether the addition of mindLAMP to the delivery of the COPSI program has an impact on implementation metrics when compared to delivery of COPSI alone.",[89,90,29],"Schizophrenia","Schizophrenia and Related Disorders",[92,93,94,95,96,97],"schizophrenia","psychosocial intervention","digital technology","task sharing","implementation","smartphone app","2026-02-10",{"date":100,"type":34},"2026-02-12",{"date":102,"type":20},"2026-07",{"date":104,"type":20},"2029-03-31",{"name":106,"class":41},"Harvard Medical School (HMS and HSDM)",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100622751","peer-support-for-whole-health-for-veterans-100622751","NCT07387692","Peer Support for Whole Health for Veterans","Randomized Controlled Trial of Peer Support for Whole Health","Inclusion Criteria:\n\n* Veterans\n* enrolled in primary care at one of the study sites\n* have some challenges with day-to-day life (e.g., relationships, work, school, getting things done) based on a standard questionnaire\n* have a recent primary care medical record note documenting potential behavioral health concerns or symptoms\n* fully understand the research study\n\nExclusion Criteria:\n\n* not be enrolled in current peer support services, mental health services, or other similar services\n* at risk for suicide or other high-risk concerns",{"count":85,"type":20},[23],"This project is evaluating a new intervention, Peer Support for Whole Health. Peer Support for Whole Health is delivered by peer support specialists, Veterans who are in recovery from mental health or substance use concerns who are employed to help other Veterans. Peer Support for Whole Health uses the Whole Health model to talk about values and self-care in all areas of life. Peer Support for Whole Health is designed to help Veterans who have difficulty with their relationships, work, or day-to-day life and may have behavioral health concerns. Peer Support for Whole Health is designed for Veterans in primary care who are not engaged in mental health or substance use treatment. The goal of this study is to find out whether Peer Support for Whole Health helps Veterans with relationships, work, or day-to-day life. This project will also study whether Peer Support for Whole Health improves well-being and mental health. Finally, this study will seek to understand how Peer Support for Whole Health works and which Veterans it helps the most.",[29,118],"Mental Health","2026-01-27",{"date":121,"type":34},"2026-02-04",{"date":123,"type":20},"2027-01-04",{"date":125,"type":20},"2030-07-01",{"name":127,"class":128},"VA Office of Research and Development","FED",2,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":15,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":42},"100535159","teachers-leading-the-front-lines---adolescent-100535159","NCT06248203","Teachers Leading the Front Lines - Adolescent","Teachers Delivering Task-Shifted Mental Health Care to Adolescents in India","TeaLeaf-A","Inclusion Criteria:\n\nSchools:\n\n* LCP (Low-Cost Private) Secondary Schools\n* Enrolled families earning \\\u003C$10 daily\n* Located in greater Darjeeling\n* Principal must also be eligible to participate\n\nPrincipals:\n\n* \\>18 years old\n* Employed at enrolled school\n* Not suspected or convicted of child maltreatment\n\nTeachers:\n\n* \\>18 years old\n* Employed at enrolled school\n* Not suspected or convicted of child maltreatment\n\nStudents:\n\n* Age 13 - 17 years\n* Student of enrolled teacher\n* Borderline or clinical Total Problem or subscale score of YSR (Youth Self-Report) and TRF (Teacher's Report Form)\n* Each student has a lead teacher (2\u002Fteacher), with their other teachers also involved\n\nGuardians\n\n* \\>18 years old\n* Guardian of enrolled student\n* Not suspected or convicted of child maltreatment\n\nExclusion Criteria:\n\n* Exclusion criteria will be set as each participant not meeting inclusion criteria as set for their group.","13 Years",{"count":140,"type":20},216,[23],"Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted adolescent mental health care.\n\nParticipants: Principals of 60 rural, low-cost private secondary schools of the Darjeeling Himalayas will be invited to participate as a school and an individual. Teachers will be approached individually. Two students per teacher who meet inclusion criteria will be randomly chosen for enrollment.\n\nProcedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods CRCT, clustered at schools, of Tealeaf-A's Reach, Adoption \\& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \\& Maintenance (Secondary Outcomes, clinically-based).",[144,145,146,29,147,148],"Adolescent Behavior","Adolescent - Emotional Problem","Mental Health Issue","Depression","Anxiety","2025-12-16",{"date":151,"type":34},"2025-12-18",{"date":153,"type":34},"2024-02-29",{"date":155,"type":20},"2027-02-01",{"name":157,"class":41},"University of North Carolina, Chapel Hill",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":50,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":42},"100614757","a-mindfulness-based-intervention-to-reduce-stress-through-the-cultivation-of-loving-kindness-compassion-joy-and-equanimity-in-healthcare-professionals-100614757","NCT07283744","A Mindfulness-Based Intervention to Reduce Stress Through the Cultivation of Loving-Kindness, Compassion, Joy, and Equanimity in Healthcare Professionals","Project FIERCE - Fostering Internal and External Respect, Compassion, and Equanimity: A Mindfulness-Based Intervention to Reduce Stress Through the Cultivation of Loving-Kindness, Compassion, Joy, and Equanimity in Healthcare Professionals","FIERCE","Inclusion Criteria: 1) full-time physician (M.D. or D.O.), 2) at least 18 years of age, 3) able to attend the six-week intervention, 4) fluent in English, and 5) access to the internet and email.\n\nExclusion Criteria. 1) having a current and consistent meditation practice (i.e., engaging in a formal meditation practice at least three days per week for five minutes each day), 2) previous participation in a Four Immeasurable course (e.g., attending a Brahmaviharas meditation retreat), 3) absence of at least mild levels of perceived stress as determined by a score less than five on the four-item Perceived Stress Scale (PSS-4; 92), 4) regular tobacco use (given its impact on immune function; 90), and 5) failure to agree to the informed consent. The presence or absence of perceived stress will be assessed using the PSS-4 during the initial phone screening.",{"count":167,"type":20},80,[23],"Nearly 50% of the adult workforce experience adverse psychological symptoms (e.g., stress, depression, burnout, etc.) stemming from workplace stressors, with healthcare workers experiencing rates as high as 80%. Some common complaints and downstream consequences of working in high-stress healthcare occupations are elevated levels of perceived stress, depression, and burnout. These conditions have been associated with unfavorable occupational (e.g., increased medical errors), patient (e.g., increased mortality rates), and provider-related outcomes (e.g., increased rates of cardiovascular disease), imposing a heavy burden on an already stretched system. Given the impact of perceived stress, depression, and burnout on employee and patient health, a clear need exists to develop effective interventions to reduce distress and promote well-being among healthcare professionals. In particular, interventions that target processes particularly vulnerable to provider stress (e.g., compassion) are needed.\n\nThe present study will evaluate the feasibility and efficacy of a mindfulness-based intervention inspired by the Buddhist Four Immeasurables practice on reducing perceived stress (primary outcome), depressive symptoms, burnout, and biological markers of inflammation, and enhancing psychological well-being and sleep quality (secondary outcomes) in 80 healthcare workers. Additionally, we will investigate several mediators (compassion, positive emotions, equanimity, and mindfulness) of intervention effects. Participants will be healthcare employees of UCLA Health. They will be enrolled in a six-week, two-arm randomized controlled trial. Participants will complete self-report questionnaires at baseline, mid-course, and post-intervention to assess study outcomes and mediators. We aim to advance the study of interventions that reduce distress and promote well-being using practices that cultivate kind feelings toward oneself and others.",[171,172,29],"Stress (Psychology)","Inflamation",[62,174,175,176,177],"compassion","loving-kindness","healthcare professional","stress","2025-12-04",{"date":149,"type":34},{"date":181,"type":34},"2025-10-10",{"date":183,"type":20},"2027-01",{"name":185,"class":41},"University of California, Los Angeles",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":129},"100514135","dialectical-behavior-therapy-for-justice-involved-veterans-100514135","NCT05974553","Dialectical Behavior Therapy for Justice-Involved Veterans","Dialectical Behavior Therapy for Justice-Involved Veterans: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Veteran aged 18+\n* Able to provide consent\n* Current or recent history of criminal justice involvement, defined as\n\n  * (a) criminal arrest, order of protection, or incarceration within two years prior to participation and\u002For\n  * (b) supervision by probation or parole at the time of participation\n\nExclusion Criteria:\n\n* Limited English proficiency\n* Inability to tolerate group therapy format\n* Enrollment in a concurrent clinical trial\n* Current or scheduled enrollment in a DBT- or RNR-based program\n* Prior participation in DBT-J program",{"count":194,"type":20},200,[23],"Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) is a comprehensive, integrative program distinctively designed to address the range of mental health, substance use, case management, and legal needs of Veterans with current or ongoing criminal justice involvement. Data from two prior clinical trials attest to the program's feasibility and acceptability and preliminarily suggest participation in the program may yield meaningful improvements in risk for criminal behavior and resolution of high-priority case management needs. However, continued research is needed to further investigate the program's efficacy. This Phase III clinical trial aims to investigate the superiority of DBT-J over a supportive group therapy treatment in decreasing risk of future criminal behavior and increasing psychosocial functioning. Secondary and exploratory aims will also investigate superiority of DBT-J in improving secondary treatment targets, potential differential efficacy across special-interest Veteran subgroups, and long-term consequences of program participation.",[198,199,29],"Criminal Behavior","Criminal Recidivism",[198,199,29,201,202,203,204],"Psychotherapy","Psychotherapy, Group","Case Management","Psychiatric Rehabilitation","2025-11-18",{"date":207,"type":34},"2025-11-19",{"date":209,"type":34},"2024-01-01",{"date":211,"type":20},"2027-12-31",{"name":127,"class":128},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":50,"sex":15,"minAge":83,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":42},"100483519","ucla-rest-study-research-on-sleep-techniques-100483519","NCT05576090","UCLA REST Study (REsearch on Sleep Techniques)","Mindful Awareness Practices vs. Sleep Education: Improving Sleep Quality During the Transition to College","REST","Inclusion Criteria:\n\n* First or second year undergraduate student at UCLA\n* Ages 18-22 years old\n* Must live in the residential halls on UCLA campus\n* Must have a score of 8 or above on the Insomnia Severity Index (ISI), indicating at least sub-threshold levels of sleep disturbance.\n\nExclusion Criteria\n\n* Current diagnosis of mood or anxiety disorder as determined by the PHQ-8 or by the GAD-7 if score \\"15\\" or more on either measure\n* Presence of medical conditions or use of medications that may influence sleep or inflammation (e.g., autoimmune disorder)\n* Previous or current formal instruction in mindfulness meditation (e.g., MAPs, MBSR) or current sleep education program","22 Years",{"count":85,"type":20},[23],"Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first and second year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects.",[226,227,29],"Sleep Disturbance","Inflammation",[229,230,231,227],"Sleep","Adolescents","Mindfulness Meditation","2025-11-05",{"date":234,"type":34},"2025-11-10",{"date":236,"type":34},"2023-04-03",{"date":238,"type":20},"2027-06-30",{"name":185,"class":41},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":42},"100569095","a-mobile-health-intervention-to-improve-psychosocial-functioning-in-veterans-with-posttraumatic-stress-disorder-and-depression-symptoms-100569095","NCT06689787","A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms","Inclusion Criteria:\n\n* Veteran\n* enrolled in VA care\n* fluent in English\n* able to provide informed consent\n* own a smartphone or willing to use a study-provided smartphone\n* have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD)\n* willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study\n\nExclusion Criteria:\n\n* history of mania or psychosis\n* current suicidal ideation with plan and intent to harm self\n* acute intoxication from alcohol or other substances\n* current or past experience with any form of STAIR",{"count":247,"type":20},40,[23],"Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.",[29,251,252],"Stress Disorders, Post-Traumatic","Depressive Disorder, Major",[254,255],"Veterans","Mobile Applications","2025-10-27",{"date":258,"type":34},"2025-10-29",{"date":260,"type":20},"2027-04-01",{"date":262,"type":20},"2029-04-01",{"name":127,"class":128},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100560722","benefits-of-choir-for-older-adults-with-unaddressed-hearing-loss-wp2-100560722","NCT06580847","Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)","Speech-in-noise, Psychosocial, and Heart Rate Variability Outcomes of Group Singing or Audiobook Club Interventions for Older Adults With Unaddressed Hearing Loss: a SingWell Project Multisite, Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Adults aged 60 years and older;\n2. Bilateral mild-to-moderate hearing loss (20-49 dB hearing level), measured using four-frequency pure-tone average across both ears (4FPTA) measured at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz;\n3. Unaddressed hearing loss (i.e., participants must not currently use a hearing aid, cochlear implant, or assistive listening device);\n4. No significant cognitive impairment, to be assessed with the Montreal Cognitive Assessment for people with hearing impairment (MoCA-H), with participants requiring a score ≥ 24;\n5. Not use a pacemaker or anti-arrhythmic agents\u002Fmedications;\n6. Not currently participating in regular active music learning (e.g., choir, formal music training) or audiobook clubs within the last year; and\n7. Sufficient language capacity to understand and complete the test materials. Note: all materials will be presented written and\u002For aurally in English at the sites located in Canada, United States of America, and Australia; Dutch at the Netherlands site; and German at the Germany site.",{"count":272,"type":20},210,[23],"Unaddressed age-related hearing loss is highly prevalent among older adults, typified by negative consequences for speech-in-noise perception and psychosocial wellbeing. There is promising evidence that group singing may enhance speech-in-noise perception and psychosocial wellbeing. However, there is a lack of robust evidence, primarily due to the literature being based on small sample sizes, single site studies, and a lack of randomized controlled trials. Hence, to address these concerns, this SingWell Project study utilizes an appropriate sample size, multisite, randomized controlled trial approach, with a robust preplanned statistical analysis.\n\nThe objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss.\n\nThe investigators designed an international, multisite, randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss. After undergoing an eligibility screening process and completing an information and consent form, the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club (control group) intervention for a training period of 12-weeks. The study has multiple timepoints for testing, that are broadly categorized as macro (i.e., pre- and post-measures across the 12-weeks), or micro timepoints (i.e., pre- and post-measures across a weekly training session). Macro measures include behavioural measures of speech and music perception, and psychosocial questionnaires. Micro measures include psychosocial questionnaires and heart-rate variability.\n\nThe investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group.",[276,277,29],"Hearing Loss, Age-Related","Speech Intelligibility",[279,280,281],"Hearing loss","speech in noise","psychosocial wellbeing","2025-09-13",{"date":284,"type":34},"2025-09-18",{"date":286,"type":34},"2025-04-15",{"date":288,"type":20},"2026-09",{"name":290,"class":41},"Toronto Metropolitan University",7,{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":21,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":42},"100551039","developing-a-smartphone-application-to-support-veteran-opioid-use-disorder-treatment-100551039","NCT06454903","Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment","Developing a Smartphone Application to Support the Functional Needs of Veterans in Medication Treatment for Opioid Use Disorder","Inclusion Criteria:\n\nFor the Phase 3, Stage 1b RCT we will be recruiting Veterans enrolled within the VA CT Healthcare System with:\n\n* Current diagnosis of Opioid Use Disorder (OUD) indicated by either DSM-5-TR or ICD-9 or -10 codes\n* Active Medication treatment for OUD prescription for buprenorphine or methadone (in any formulation)\n* A working smartphone with wireless capabilities (to allow for download of ACT to RECOVER) or is willing to use a study-provided smartphone\n* Competency to provide written informed consent\n* 18 years of age or older\n\nExclusion Criteria:\n\nParticipants may not:\n\n* Have been on MOUD, in their current treatment episode (i.e., since their most recent induction), for longer than 12 consecutive months prior to their baseline visit\n* Have untreated major psychiatric disorders (e.g., bipolar disorders, psychotic disorders)\n* Be expressing current, active suicidal\u002Fhomicidal ideation (i.e., current intent to harm themselves or someone else)\n* Have any cognitive\u002Fmedical impairment precluding study participation or use of smartphones\u002Fsmartphone applications.",{"count":300,"type":20},75,[23],"Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD; e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD.\n\nAcceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care.\n\nFortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in \"real-world\" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD.\n\nThe proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called \"ACT to RECOVER\" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery).\n\nThe study will occur in 3 phases:\n\nPhase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10).\n\nPhase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability.\n\nPhase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20).\n\n* (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures.\n* (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.",[304,29,305],"Opioid-Related Disorders","Quality of Life",[304,29,305,255,307,308,309],"Smartphone Apps","Acceptance and Commitment Therapy","User-Centered Design","2025-08-26",{"date":312,"type":34},"2025-08-27",{"date":314,"type":34},"2025-04-02",{"date":316,"type":20},"2029-09-30",{"name":127,"class":128},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":15,"minAge":83,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":42},"100603012","body-composition-and-psychosocial-factors-in-ici-treated-cancer-patients-100603012","NCT07130981","Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients","Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Aged 18 years or older\n* Having undergone a CT scan (at the L3 level) prior to treatment\n* No severe mental disorder and able to communicate effectively\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Did not provide written informed consent\n* Patients deemed unsuitable by the physician",{"count":194,"type":20},"OBSERVATIONAL","Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors",[329,29,330,331],"Cancer","Treatment Side Effects","Cachexia","2025-08-19",{"date":334,"type":34},"2025-08-24",{"date":336,"type":20},"2025-09-01",{"date":338,"type":20},"2026-01-01",{"name":340,"class":41},"Hacettepe University",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":15,"minAge":349,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":42},"100561213","teachers-leading-the-front-lines---north-carolina-tealeaf-nc-100561213","NCT06587230","Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)","Building Teachers Mental Health Skills to Support Students With Mental Health Needs in Elementary and Middle Schools in North Carolina: Program Implementation and Prospective Data Collection","Tealeaf-NC","Inclusion Criteria:\n\nSchools:\n\n* Have been trained in either Tealeaf or RE-SEED in Summer 2024 or 2025 after being randomized programmatically\n* Be a school in the State of North Carolina\n* Have an eligible principal\n\nPrincipals:\n\n* \\>18 years old\n* Employed at an enrolled school\n* Not suspected or convicted of child-related misconduct or maltreatment\n\nTeachers:\n\n* \\>18 years old\n* Employed at an enrolled school\n* Primary teaching responsibility for a single academic class (for a minimum of 1 hour per day and a minimum of 4 days per week) in any grade level Kindergarten to Grade 8\n* Not suspected or convicted of child-related misconduct or maltreatment\n\nCounselors:\n\n* \\>18 years old\n* Employed at an enrolled school\n* Hold a school counselor position at an enrolled school for at least 10 hours per week\n* Not suspected or convicted of child-related misconduct or maltreatment\n\nStudents:\n\n* Enrolled in Kindergarten-Grade 8\n* Student of an enrolled teacher\n* Has a parent or guardian who can provide consent\n* Positive\u002FClinical-level score on the Strengths and Difficulties Questionnaire (SDQ)\n\nGuardians:\n\n* \\>18 years old\n* Guardian of enrolled student\n\nExclusion Criteria:\n\n* Exclusion criteria will be set as each participant does not meet the inclusion criteria as set for their group.","5 Years","99 Years",{"count":352,"type":20},312,[23],"Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care.\n\nParticipants: \\~300 estimated\n\nProcedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \\& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \\& Maintenance (Secondary Outcomes, clinically-based).",[356,146,29,147,148],"Child Behavior","2025-06-23",{"date":359,"type":34},"2025-06-27",{"date":361,"type":34},"2024-10-08",{"date":363,"type":20},"2027-02",{"name":157,"class":41},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":15,"minAge":373,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":376,"briefSummary":377,"conditions":378,"keywords":384,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":42},"100529509","building-resilience-for-surgical-recovery-100529509","NCT06174701","Building Resilience for Surgical Recovery","Building Resilience for Surgical Recovery: Feasibility and Acceptability Pilot Study","BRSR","Inclusion criteria:\n\n* ≥ 65 years of age on the day of surgery\n* Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures\n* Depressive symptoms - Patient Health Questionnaire (PHQ-9) screening with a score of 5+, 5-9 being subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, we need to have at least one of these items included: \"at least one of the endorsed items needs to be depressed mood or diminished activities\" (questions #1 and #2)\n\nExclusion criteria:\n\n* Those with severe cognitive impairment - Short Portable Mental Status Questionnaire (SPMSQ) screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment\n* Unable to read, speak, and understand English\n* Current alcohol or other substance abuse (scoring 2+ on CAGE questionnaire or answering yes to \"Do you currently use any non-prescription drugs or substances?\")\n* Life expectancy is 6 months or less","65 Years",{"count":375,"type":20},90,[23],"The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?",[29,379,380,381,382,383],"Surgery","Older Adults","Physical Function","Postoperative Outcome","Depressive Symptoms",[29,379,380,381,382,383],"2025-04-28",{"date":387,"type":34},"2025-05-01",{"date":389,"type":34},"2024-06-04",{"date":391,"type":20},"2025-06-04",{"name":393,"class":41},"The University of Texas Health Science Center, Houston",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":15,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":42},"100581785","siblings-to-a-child-with-cancer-needs-and-pre-loss-grief-100581785","NCT06854822","Siblings to a Child with Cancer: Needs and Pre-loss Grief","Siblings to a Child with Cancer: Psychometric Evaluations of Instruments Assessing Siblings Needs and Pre-loss Grief","Inclusion Criteria:\n\n* Age: 12-24 years\n* Have a brother or sister with childhood cancer\n* Swedish speaking siblings\n\nExclusion Criteria:\n\n-Bereaved siblings","12 Years","24 Years",{"count":194,"type":20},"Background and Aim: Siblings to a brother or sister with cancer have reported difficulties dealing with such things as their parents' suffering, loneliness in relation to their own feelings as well as uncertainty regarding their brother's\u002Fsister's treatment, prognosis and survival. Siblings also struggle with fear of death and dying, and unresolved grief. Unfortunately, siblings are a forgotten group both in society, within the family, in health care, in school, and in research even if there has been a huge improvement the last 10 years. These children's needs must be identified and handled during the illness trajectory as a way of supporting their challenging situation and prevent avoidable psychological distress. Nevertheless, there exists no validated standardized assessment instrument in Swedish that measure the needs of these children even if it is well known that it is beneficial for emotional and psychological well-being to use assessment instrument. Moreover, no instrument in Swedish exists that identify children with prolonged pre-death grief despite that prolonged grief during illness is associated with psychological distress. This study therefore aim to translate, culturally adapt, and evaluate the psychometric properties of the Swedish version of the Sibling Cancer Needs Instrument (SCNI) and Prolonged Grief Disorder (PG-12) among children and youths who have a brother or sister with cancer.\n\nMaterial and Methods: Present instruments will be translated and culturally adapted according to the World Health Organization's (WHO) guidelines. After that, the psychometric properties of the Swedish version of SCNI and PG-12 will be examined. The Swedish version of the SCNI and PG-12 will be revised by a group of several experts in psychology, paediatric oncology, and family health, for its face and content validity. In addition, pre-test respondents will include approx. 10 siblings. They will be recruited from one of the six pediatric oncology centers in Sweden, the home care for children at the same hospital, and at the hospice for children and youths in Sweden (Lilla Erstagården) where established collaborations with clinicians exists today with sibling supporters. Information about the study will be given by the researchers who also ask for informed consent. Children aged 15 years and older consent themselves while those between 12-14 years have to have consent from their guardian(s)\u002Fparent(s). Pre-test respondents will be administered SCNI and PG-12 and be systematically debriefed. During debriefing, siblings will be asked what they thought the question was asking, whether they could repeat the question in their own words, what came to their mind when they heard a particular phrase or term. They will also be asked to explain how they choose their answer. These questions will be repeated for each item. The answers to these questions should be compared to the respondent's actual responses to the instrument for consistency. Respondents will also be asked about any word they did not understand as well as any word or expression that they found unacceptable or offensive. Finally, when alternative words or expressions exist for one item or expression, the pre-test respondent should be asked to choose which of the alternatives conforms better to their usual language. After that, siblings will be asked to participate in a web-survey. They will be recruited from: 1) the six pediatric oncology centers in Sweden, 2) the hospice for children and youths in Sweden (Lilla Erstagården), and 3) via advertisement on social media, e.g. on Instagram at \"Nära Cancer\" and the Childhood Cancer Fund. The siblings will also be identified by a sibling supporter at the six pediatric oncology centers and Lilla Erstagården. The sibling supporters will invite the siblings to the study by giving them a web address to a website where they will find information about the study. On the website, the siblings could either go directly to the web-survey (if the sibling is 15 years or older) or register their interest to participate in the web-survey (if the sibling is between 12-14 years). Parents of siblings who register their interest to participate in the web-survey on the website (siblings aged 12-14 years), will be contacted by a researcher via email or phone (depending on how they wish to be contacted), and the parents\u002Fguardians and the sibling will be informed about the study, and informed consent will be granted from both guardians\u002Fparents. Advertisement on social media will take the siblings or parents\u002Fguardians to the same web-page\u002Fweb-survey as previously described.\n\nAnalysis: Descriptive statistics will be used to present demographic data and study variables, including means and standard deviations, medians and quartiles, and frequencies. We will use factor analysis in order to evaluate the fit of the models. A sample size of 200 will be acceptable if the models are not too complex.",[406,407,29],"Childhood Cancer","Siblings","2025-03-03",{"date":410,"type":34},"2025-03-05",{"date":412,"type":20},"2025-03-01",{"date":72,"type":20},{"name":415,"class":41},"Ersta Sköndal University College",{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":15,"minAge":423,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":427,"briefSummary":428,"conditions":429,"keywords":435,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":42},"100517579","intervention-to-enhance-coping-and-help-seeking-among-youth-in-foster-care-100517579","NCT06019377","Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care","Pilot Testing an Intervention to Enhance Coping and Increase Mental Health Help-seeking Among Transition-age Youth in Foster Care","Inclusion Criteria:\n\n* Eligible to receive federally-funded transition-related services in Oregon (ages 16-20 and in foster care at least 90 days after they turned age 14),\n* Indicated behavioral health risk. Behavioral health risk is indicated by child welfare administrative indicators of lifetime behavioral health need or service involvement (DSM diagnoses, psychotropic medication, emotional-behavioral disability, congregate care\u002Fresidential placement)\n\nExclusion Criteria:\n\n* Inability to actively participate in the intervention, including you who are: non-English speaking, significantly developmentally disabled, or where participation is otherwise contraindicated (e.g., youth is in crisis, youth is in a placement that will not allow for participation)","16 Years","20 Years",{"count":426,"type":20},106,[23],"This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.",[144,29,430,431,432,147,148,251,433,434],"Coping Behavior","Help-Seeking Behavior","Utilization, Health Care","Emotion Regulation","Child Welfare",[436,437,438,439,440,441,442],"Mental health","Help-seeking","Coping","Youth","Foster care","Near-peer","Independent living","2025-02-25",{"date":445,"type":34},"2025-02-28",{"date":447,"type":34},"2024-04-22",{"date":449,"type":20},"2026-08-01",{"name":451,"class":41},"Portland State University",{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":50,"sex":15,"minAge":459,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":21,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":42},"100561929","aspirational-rehabilitation-coaching-for-holistic-health-arch-a-pilot-pre-post-experimental-study-100561929","NCT06596551","Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study","Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Evaluation of Psychosocial Recovery in First-Time Stroke Survivors and Family Caregivers","Inclusion Criteria:\n\n* Aged 21 years and above\n* Recovering from their first stroke at mild to moderate degree of severity\n* Discharged from inpatient care at no later than 3 months,\n* Clinically assessed to have cognitive capacities to engage in and complete the research study,\n* Language capabilities in English or Mandarin, and\n* One identified primary family caregiver aged 21 years and above with similar language capabilities.\n\nExclusion Criteria:\n\n* Families with survivors suffering from aphasia,\n* Being too ill to participate,\n* Experiencing moderate to severe cognitive impairment, and\n* With family caregivers who are not interested to participate.","21 Years",{"count":461,"type":20},60,[23],"The ARCH programme is a novel, strength-based, dyadic, multicomponent psychosocial intervention that blends together psychoeducation, psychosocial support and self-compassion practices to aid first-time stroke survivors and their family caregivers with their psycho-socio-emotional and spiritual challenges following discharge from in-patient care. A pre-post experimental design with a feasibility and acceptability assessment is adopted to evaluate and refine the ARCH intervention in promoting wellbeing, self-compassion, independence, quality of life, hope, resilience, self-efficacy and dyadic mutuality.",[465,466,29],"Stroke","Psychological Well-Being","2024-09-11",{"date":469,"type":34},"2024-09-19",{"date":471,"type":34},"2024-03-01",{"date":473,"type":20},"2026-09-01",{"name":475,"class":41},"Nanyang Technological University",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":15,"minAge":401,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":21,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":42},"100534756","the-prism-social-needs-prism-sn-intervention-for-adolescents-and-young-adults-with-cancer-100534756","NCT06242964","The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer","The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 12-25 years\n* Diagnosed with new malignancy treated with chemotherapy and\u002For radiation \\\u003C6-months\n* Able to speak in the English language\n* Able to read in the English language\n* Cognitively able to participate in intervention sessions and complete surveys\n\nExclusion Criteria:\n\n* Aged \\\u003C12 or \\>25 years\n* Diagnosed with recurrent malignancy\n* Diagnosed with new malignancy \\>6 months\n* Not receiving chemotherapy and\u002For radiation\n* Not able to speak in the English language\n* Not able to read in the English language\n* Not cognitively able to participate in intervention session or complete surveys","25 Years",{"count":485,"type":20},100,[23],"The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to:\n\n1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback.\n2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care.\n\nParticipants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.",[329,489,29,490],"Social Functioning","Coping Skills","2024-06-23",{"date":493,"type":34},"2024-06-25",{"date":495,"type":34},"2024-05-15",{"date":497,"type":20},"2026-07-31",{"name":499,"class":41},"Seattle Children's Hospital"]