[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depressive-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depressive-symptoms":667},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,45,91,127,147,177,208,230,252,274,297,322,346,373,394,417,440,463,488,506,554,578,604,622,644],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100531932",false,"NCT06206226","The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study","The Oh Happy Day Class - Digital Connections (OHDC-DC): an Exploratory Pilot Study","OHDC-DC","Inclusion Criteria:\n\n* African-American\n* Age 18 and older\n* Experiencing depression (as evidenced by a score of 5 or higher on the PHQ-9)\n* Own a mobile phone\n\nExclusion Criteria:\n\n* Individuals who are currently receiving psychotherapy\n* Individuals who are presently experiencing suicidal ideation\n* Individuals who started psychotropic medication less than three months prior to the start of the OHDC will be excluded from the study\n* Participants scoring 25 or higher on the PHQ-9 will be screened out","ALL","18 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression.\n\nParticipants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.",[27,28,29],"Depression","Depressive Disorder","Depressive Symptoms",[31],"African American","NOT_YET_RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":21},"2026-07",{"date":40,"type":21},"2027-02",{"name":42,"class":43},"University of Wisconsin, Madison","OTHER",1,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":76,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":44},"100551600","NCT06462196","Natural History of Depression, Bipolar Disorder and Suicide Risk","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","120 Years",{"count":52,"type":21},500,"OBSERVATIONAL","Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,29,73,74,75],"Behavioral Symptoms","Suicide","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Ketamine","Depression, Unipolar","Treatment Resistant Depression","Major Depressive Disorder","Depression, Bipolar",[77,57,74,78,79,80,73],"Neurobiology","Bipolar Disorder","Biomarkers","Suicide Risk","RECRUITING","2026-06-26",{"date":33,"type":36},{"date":85,"type":36},"2024-09-09",{"date":87,"type":21},"2030-06-01",{"name":89,"class":90},"National Institute of Mental Health (NIMH)","NIH",{"id":92,"slug":4,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":44},"100609572","NCT07216326","Our Voices Matter: Intervention for Depression in Youth","Our Voices Matter: Racial Justice Activism Intervention to Address Structural Racism and Prevent Depression in Black and Latinx Youth","OVM","Inclusion Criteria:\n\n1. 15-20 years old\n2. Identify as Black and\u002F or Latinx\n3. Speak English\n\nExclusion Criteria:\n\n1. Younger than 15 years old, or older than 20 years old\n2. Unable to attend the in-person sessions\n3. Non-fluent English speaker\n4. Do not identify as Black or Latinx",true,"15 Years","20 Years",{"count":102,"type":21},300,[24],"Over 15 million people participated in racial justice protests nationwide during 2020-2021 spotlighting activism as a collective tool against structural racism and discrimination (SRD). SRD manifests as policies and practices (e.g., redlining, voter suppression, mass incarceration) that produce hostile environments that contribute to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death, concentrated within Black and Latinx populations. While the connection between SRD and health is well documented, few studies provide evidence on strategies to reduce SRD and mitigate consequences on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that improve the mental and physical health of Black and Latinx populations, beginning in adolescence. The study's specific aims are to 1) Determine whether a racial justice activism behavioral intervention prevents and reduces depressive symptoms in Black and Latinx adolescents and young adults and 2) Determine whether a racial justice activism behavioral intervention lowers allostatic load scores in Black and Latinx adolescents and young adults. To accomplish these aims, the team will conduct a stage II group-based, multi-component, and multilevel randomized behavioral clinical trial. The investigators will collect psychological and physiological measures at baseline, then at defined intervals for 2 years post the racial justice activism intervention.",[29,106,107],"Allostatic Load","Metabolic Syndrome",[109,110,111,112,113,114,115,116,117],"mental health","youth intervention","allostatic load","stress","depressive symptoms","depression","metabolic syndrome","prevention","inflammation","2026-06-12",{"date":120,"type":36},"2026-06-15",{"date":122,"type":36},"2025-06-06",{"date":124,"type":21},"2028-12-29",{"name":126,"class":43},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":128,"slug":4,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":44},"100594524","NCT07020572","Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)","The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care","Inclusion Criteria:\n\nFor Adolescent Participants\n\n1. Adolescents ages 13 to 17 years.\n2. Adolescents must be English-speaking.\n3. Legal guardian permission (informed consent) and child consent\u002Fassent.\n4. A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.\n5. Access to a phone, computer, or other electronic device that could be used for study activities\n\nFor Legal guardian Participants\n\n1. Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit.\n2. Consent to participate.\n3. English-speaking.\n4. Access to a phone, computer, and\u002For tablet to complete remote evaluations.\n\nExclusion Criteria:\n\nExclusion criteria will be determined based on electronic health record (EHR) review, eligibility screening questions, the baseline evaluation, and any other interactions with the family.\n\n1. Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 \"In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?\" and\u002For yes to either of the supplemental questions which ask, \"Has there been a time in the past month when you have had serious thoughts about ending your life?\" and \"Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?\") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month (\"Has there been a time in the past month when you have had serious thoughts about ending your life?\") will be excluded.\n2. Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.\n3. Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.","13 Years","17 Years",{"count":136,"type":21},45,[24],"This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.",[29],{"date":120,"type":36},{"date":142,"type":36},"2025-03-20",{"date":144,"type":21},"2027-06",{"name":146,"class":43},"Children's Hospital of Philadelphia",{"id":148,"slug":4,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":153,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":44},"100642691","NCT07639099","Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression","Impact of Intranasal Esketamine-dexmedetomidine Combination on Postpartum Depression in Parturients With Prenatal Depressive Symptoms: a Randomized, Double-blind, and Placebo-controlled Trial","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years who are preparing for childbirth;\n* Positive prenatal depression screening, defined as a Patient Health Questionnaire-9 (PHQ-9) score ≥5.\n\nExclusion Criteria:\n\n* History of schizophrenia or existence of communication barriers;\n* Severe obstetric complications, including severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placental abruption, or ASA physical status classification \\>III;\n* Contraindications to ketamine\u002Fesketamine, including refractory hypertension, severe cardiovascular disease (NYHA class ≥III), or hyperthyroidism;\n* Contraindications to dexmedetomidine, including severe bradycardia (heart rate \\\u003C50 bpm), or second-degree or higher atrioventricular block;\n* Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause);\n* Refusal to participate in this study or concurrent participation in another clinical trial.","FEMALE",{"count":155,"type":21},164,[157],"PHASE4","Esketamine has rapid-onset antidepressant effects and may reduce postpartum depression in parturients with prenatal depressive symptoms. However, its adverse neuropsychiatric symptoms limits clinical application. Dexmedetomidine can alleviate these adverse symptoms and has independent antidepressant effect. This randomized, double-blind, placebo-controlled trial is designed to evaluate whether intranasal esketamine combined with dexmedetomidine can reduce the prevalence of postpartum depression in women with prenatal depressive symptoms.",[160,29,161,162,163,164],"Parturients","Esketamine","Dexmedetomidine","Intranasal Administration","Postpartum Depression",[160,166,161,162,167,168],"Prenatal depressive symptoms","Intranasal administration","Postpartum depression","2026-06-11",{"date":120,"type":36},{"date":172,"type":21},"2026-06",{"date":174,"type":21},"2029-12",{"name":176,"class":43},"Peking University First Hospital",{"id":178,"slug":4,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":44},"100641674","NCT07652775","rTMS Combined With Aerobic Exercise for Older Adults With Mild Cognitive Impairment and Comorbid Depression","Effects of Repetitive Transcranial Magnetic Stimulation Combined With Aerobic Exercise on Cognitive Function, Psychological Health, and Walking Performance in Older Adults With Mild Cognitive Impairment and Comorbid Depression: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 65 to 90 years.\n2. Diagnosed with mild cognitive impairment (MCI) according to established clinical criteria.\n3. Presence of depressive symptoms as determined by clinical assessment and Beck Depression Inventory-II (BDI-II).\n4. Able to communicate and follow study instructions.\n5. Able to ambulate independently with or without an assistive device.\n6. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of dementia.\n2. History of epilepsy or seizure disorder.\n3. Presence of metallic implants, pacemakers, cochlear implants, or other contraindications to transcranial magnetic stimulation.\n4. Major neurological disorders, including stroke, Parkinson's disease, traumatic brain injury, or other neurodegenerative diseases.\n5. Severe psychiatric disorders other than depression.\n6. Severe cardiovascular, musculoskeletal, or medical conditions that preclude participation in aerobic exercise.\n7. Severe visual or hearing impairments that interfere with cognitive assessment.\n8. Current participation in another intervention study.","65 Years","90 Years",{"count":136,"type":21},[24],"This study aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) and aerobic exercise on cognitive function and mental health in older adults with mild cognitive impairment (MCI) and comorbid depression. Forty-five participants will be randomly assigned to one of three groups: (1) rTMS alone, (2) rTMS combined with stationary cycling exercise, or (3) sham rTMS combined with stationary cycling exercise. Participants will receive 20 intervention sessions over a 5-week period (4 sessions per week). Outcomes, including cognitive function, depressive symptoms, sleep quality, life satisfaction, self-efficacy, and gait performance, will be assessed at baseline, immediately after completion of the 5-week intervention, and at a 1-month follow-up. The findings may contribute to the development of evidence-based, non-pharmacological interventions for improving cognitive and mental health outcomes in older adults with MCI and comorbid depression.",[189,29],"Mild Cognitive Impairment (MCI)",[191,192,193,194,195,196,197,198,199],"Repetitive Transcranial Magnetic Stimulation","Aerobic Exercise","Dual-Task Walking","Timed Up and Go","Cognitive Function","Older Adults","Life Satisfaction","Gait Performance","rTMS",{"date":201,"type":36},"2026-06-17",{"date":203,"type":36},"2026-03-03",{"date":205,"type":21},"2027-12-31",{"name":207,"class":43},"Cheng-Hsin General Hospital",{"id":209,"slug":4,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":215,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":44},"100560199","NCT06574035","Michigan Men's Diabetes Project III(MenDIII): Mind and Motion","Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion","MenDIII","Inclusion Criteria:\n\n* African American\u002FBlack males\n* age 18 years or older\n* ambulatory status\n* diagnosis of Type 2 Diabetes (T2D) for one year duration or longer\n* be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year\n* be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)\n* have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks\n* live in the Wayne or Washtenaw County\\\\\n* have reliable transportation to in-person events\n\nExclusion Criteria:\n\n* stage 2 hypertension as defined by Joint National Committee (JNC) VIII\n* recent cardiac events\n* recent laser surgery for proliferative retinopathy\n* history of stroke\n* lower limb amputation\n* peripheral neuropathy\n* severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)\n* class III or IV heart failure\n* medical instability.\n\nPer American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:\n\n* ongoing unstable angina\n* uncontrolled cardiac arrhythmia with hemodynamic compromise\n* active endocarditis\n* symptomatic severe aortic stenosis\n* acute myocarditis or pericarditis\n* acute aortic dissection\n* acute pulmonary embolism\n* pulmonary infarction\n* deep venous thrombosis\n* physical disability that precludes safe and adequate testing\n* chest discomfort with exertion\n* unreasonable breathlessness, or dizziness, fainting, or blackouts.\n\nAs part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.\n\nIf you are interested in the study, please complete our screening survey: https:\u002F\u002Fredcapproduction.umms.med.umich.edu\u002Fsurveys\u002F?s=JNPPEDANX7KLPPF9. Thank you so much!","MALE",{"count":217,"type":21},80,[24],"The Michigan Men's Diabetes Project III: Mind \\& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours\u002Fsessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.",[221,29,27],"Diabetes Mellitus, Type 2","2026-06-10",{"date":118,"type":36},{"date":225,"type":36},"2025-01-13",{"date":227,"type":21},"2026-09",{"name":229,"class":43},"University of Michigan",{"id":231,"slug":4,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100540313","NCT06315218","Examining the Health Effects of NPOWER365 Among Black Same Gender Loving Men","Inclusion Criteria:\n\n1. Identify as Black or African American, regardless of ethnicity\n2. Identify as male, regardless of sex assigned at birth\n3. Are living with HIV and prescribed a daily ART regimen\n4. Are age ≥ 18;\n5. Have sex with men\n6. Own an internet-connected device (e.g., smartphone, tablet)\n7. Reside in the Atlanta-area EHE jurisdictions.\n\nExclusion Criteria:\n\n1. Lack of English fluency\n2. Past participation in the pilot.",{"count":236,"type":21},350,[24],"This research study aims to test the effectiveness, reach, and maintenance over time of the NPOWER365 HIV care intervention for Black men who have sex with men (BMSM) living with HIV. NPOWER365 is a BMSM community-developed multicomponent intervention that aims to: 1) Support daily health promotion via HIV health education and health maintenance reminders; 2) Foster positive social connections among BMSM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to BMSM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment.",[240,241,242,29,243],"Sexual and Gender Minorities","Social Stigma","Medication Adherence","Anxiety Symptoms","2026-06-08",{"date":222,"type":36},{"date":247,"type":21},"2026-08",{"date":249,"type":21},"2028-04",{"name":251,"class":43},"Rutgers, The State University of New Jersey",{"id":253,"slug":4,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":153,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":44},"100522645","NCT06085313","Cancer Pain Management Using a Web-based Intervention","Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors","CAI","Inclusion Criteria:\n\n* women aged 18 years and older who identify as Chinese, Korean, or Japanese;\n* have had a breast cancer diagnosis in the past;\n* can read and write English, Mandarin (simplified or traditional), Korean, or Japanese;\n* have access to the internet through computers or mobile devices (mobile phones and tablets);\n* have experienced cancer pain during the past week (at least 1 on a scale from 0 to 5 \\[no symptom=0, mild symptom that does not bother=1, somewhat bothering symptom=2, moderate symptom=3, severe symptom=4, and worst possible symptom=5\\]);\n* have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire) which is equivalent to the cut-point of minimal to moderate depression.\n\nExclusion Criteria:\n\n* less than 18 years old because their cancer experience would be different from that of adults.\n* Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past five years, will be excluded.\n* Those who participated in the PI's pilot studies will be excluded.\n* The participants of R33 phase will exclude those in active depression treatment regardless of their level of depression.\n* Those without Internet access will be excluded, but those with Internet access through community\u002Fgroup computers will be included.",{"count":102,"type":21},[24],"This study is funded by the HEAL Initiative (https:\u002F\u002Fheal.nih.gov\u002F). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching\u002Fsupport program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.",[263,29,264],"Cancer of Breast","Cancer Pain","2026-06-06",{"date":267,"type":36},"2026-06-09",{"date":269,"type":36},"2024-02-20",{"date":271,"type":21},"2027-08-31",{"name":273,"class":43},"University of Texas at Austin",{"id":275,"slug":4,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":280,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":44},"100610510","NCT07228520","Strength and Pain-Coping Through Resilience and Knowledge","SPARK","Inclusion Criteria:\n\n* Self-report pain \\>3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do\n* Live in the community\n* Live in Central Maryland\n* Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)\n* Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)\n* One ADL or IADL limitation\n\nExclusion Criteria:\n\n* Hospitalized \\> 3 times in the last year\n* Participating in physical therapy\n* Have a terminal diagnosis (\\\u003C1 year expected survival)\n* \\> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)\n* Unable to speak or understand English","50 Years",{"count":282,"type":21},100,[24],"Older adults who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the SPARK intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.",[286,29,287],"Pain","Aging",[196],"2026-06-01",{"date":291,"type":36},"2026-06-03",{"date":289,"type":36},{"date":294,"type":21},"2028-11-30",{"name":296,"class":43},"Johns Hopkins University",{"id":298,"slug":4,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100489874","NCT05658796","RXWell to Decrease Post-Operative Opioid Use in Total Knee or Hip Arthroplasty","Telemedicine-delivered Digital Cognitive Behavioral Intervention to Decrease Post-operative Opioid Use Among Patients Undergoing Total Knee or Hip Arthroplasty","RxWell","Inclusion Criteria for the RXWell Study:\n\n* Adults \\>18 years\n* Scheduled for elective primary total knee arthroplasty (TKA) or hip replacement (THA) at the approved UPMC hospitals\n* Moderately high levels of mood disorder symptoms on validated PROMIS measures, defined as a T-score \\> or = to 60 on PROMIS Anxiety 4a short form and\u002For PROMIS Depression4a short form\n\nExclusion Criteria for the RXWell Study:\n\n* Patients undergoing non-elective surgery or secondary arthroplasty\n* Active delirium, neurocognitive impairment, or severe intellectual disability\n* No access to a smart device (phone or tablet)\n* Active alcoholism (defined as daily use of more than 1 liter of wine and \u002For 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)\n* Profound mood disorders requiring immediate intervention such as suicidal ideation, defined as a PROMIS Depression score of more than 70\n* A PROMIS Anxiety and\u002For Depression T-score \\>70, which corresponds to severe anxiety and depression.\n\n  * Patients needing immediate care will be referred to psychiatrists and primary team.","100 Years",{"count":306,"type":21},150,[24],"It is envisioned that multipronged benefits from this pilot work for the UPMC ISD and its members. It is expected the RxWell platform to provide the following benefits: expansion of the use of RxWell to all UPMC ISD members providing peri-operative mood management with advantage of improved peri-operative outcomes, improving saving for the UPMC ISD by hastening the recovery and decreased resource utilization, and addition to the high-value care of UPMC with this holistic approach to patient perioperative care",[310,311,29,27,312,313],"Mood Disorders","Anxiety","Anxiety Disorders","Anxiety Depression",{"date":291,"type":36},{"date":316,"type":36},"2023-01-27",{"date":318,"type":21},"2026-12-30",{"name":320,"class":43},"University of Pittsburgh",3,{"id":323,"slug":4,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":44},"100467642","NCT05369429","My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life","My Wellbeing Guide, Technology Facilitated Behavioral Intervention for Depression Among Diverse Patients in Ambulatory Oncology","R37","Inclusion Criteria:\n\na) having been reached out to by the study team for recruitment; (b) planned treatment and follow-up within the NM or UHealth healthcare system; (c) ≥ 18 years of age; (d) medical chart confirmed diagnosis of a solid or hematological malignancy; (e) elevated depressive symptoms on the PROMIS CAT (score \\> or = 55) within the last 3 months; (f) access to the internet; (g) willingness to be randomized; (h) able to read English or Spanish; (i) patients must have signed informed consent prior to registration on study\n\nExclusion Criteria:\n\nNote: The investigators will not include any vulnerable populations in this study.",{"count":330,"type":21},6516,[24],"The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System. Eligible patients will be directly contacted by the study team for recruitment.\n\nThe intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.\n\nParticipants are randomized into either an intervention application (described above) or a control application (which will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website.) Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.",[334,311,29],"Cancer",[336,337],"eHealth","Wellbeing","2026-05-28",{"date":289,"type":36},{"date":341,"type":36},"2022-12-02",{"date":343,"type":21},"2028-07-05",{"name":345,"class":43},"Northwestern University",{"id":347,"slug":4,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":98,"sex":215,"minAge":352,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":369,"leadSponsor":371,"locationsCount":321},"100640953","NCT07608796","JAK Signaling in Depression and Cognition in Male Football Players","JAK DC in Play","Inclusion Criteria:\n\n* willing and able to give written informed consent\n* males\n* \\>10 years of playing football (at least 1 year in the NFL)\n* 40-55 years of age\n* Current Diagnostic and Statistical Manual (DSM)-V major depression or Bipolar, depressed type; or DSM-V major depression or Bipolar, depressed type in partial remission as diagnosed by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)-V\n* score of \\>10 on the PHQ-9 from screening and HAM-D score ≥16 for study entry\n* off all antidepressant or other psychotropic therapy (e.g., mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks before baseline visit (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks (and no planned changes)\n* CRP ≥3 mg\u002FL\n* PHQ-9 anhedonia (item #1) and cognitive (item #7) scores ≥2\n\nExclusion Criteria:\n\n* current or history of past autoimmune disorder\n* history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection\n* history of any type of cancer requiring treatment with more than minor surgery\n* unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG, and laboratory testing)\n* significant hematological abnormalities at screening (ANC \\\u003C 1500, Hgb\\\u003C10, platelet\\\u003C 100,000)\n* history of progressive multifocal leukoencephalopathy\n* history of deep venous thrombosis\n* history of cardiovascular disease (coronary artery disease, congestive heart failure, stroke - controlled hypertension is OK)\n* major surgery within 6 months before screening, or will require major surgery during the study\n* current or recent (\\\u003C4 weeks before study start) viral (including COVID-19), bacterial, fungal, or parasitic infection, or any other active or recent infection\n* symptomatic herpes zoster infection at or within 12 weeks of study start\n* history of disseminated\u002Fcomplicated herpes zoster (for example, ophthalmic zoster or CNS involvement)\n* cirrhosis of the liver from any cause\n* Additional exclusion criteria apply","40 Years","55 Years",{"count":355,"type":21},30,[357],"PHASE2","This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 10 years of organized football. This will be evaluated using a medication called baricitinib that blocks one aspect of inflammation.",[29,360],"Cognitive Symptom",[362,363,364],"Football player","Inflammation","NFL","2026-05-20",{"date":367,"type":36},"2026-05-27",{"date":172,"type":21},{"date":370,"type":21},"2027-10",{"name":372,"class":43},"Emory University",{"id":374,"slug":4,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":44},"100560871","NCT06582784","IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)","Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Likely Incurable Cancer","IMPACT","Inclusion Criteria:\n\n* Age \\> 18 years\n* ILLIC (as determined during manual chart review)\n* Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9\n* Current owner of an iOS- or Android-compatible smartphone\n* Willingness to utilize a mobile app for the treatment of depressed mood (response of \"yes\" on yes\u002Fno item)\n* Have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)\n* English language fluency\n\nExclusion Criteria:\n\n* Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9\n* Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as:\n* Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or\n* Self-report of cognitive difficulties that impair functional independence",{"count":381,"type":21},279,[24],"The purpose of this research study is to evaluate a mobile application (app) for depression treatment called \"Moodivate\" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood.\n\nParticipants will be randomly assigned to either download the mobile app, \"Moodivate\", or not. Approximately 2\u002F3 of participants enrolled will receive the mobile app and the remaining 1\u002F3 will not.\n\nAll participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today.\n\nParticipation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and\u002For loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.",[27,29,334],"2026-05-19",{"date":387,"type":36},"2026-05-22",{"date":389,"type":36},"2024-10-28",{"date":391,"type":21},"2028-09-01",{"name":393,"class":43},"Medical University of South Carolina",{"id":395,"slug":4,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":352,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":415,"locationsCount":44},"100497200","NCT05754151","Mobile CBT for Middle Aged and Older Adults","Feasibility and Acceptability of a Mobile Cognitive Behavior Therapy App Targeting Depression and Anxiety in Older Adults","Inclusion Criteria:\n\n* Age 40 or older\n* Primary diagnosis of an anxiety or depressive disorder as determined by a clinical severity rating score of 4 or greater on the Anxiety Disorders Interview Schedule (ADIS).\n* Mini Mental Status Exam (MMSE) no more than 1 SD below the mean score for patient's age and education. If the remote version of the MMSE is used (e.g. during an evaluation on Zoom), the remote MMSE score will be converted to a standard MMSE score.\n* Access to an Apple iPhone, iPad, or Android device.\n\nExclusion Criteria:\n\n* Lifetime diagnosis of a bipolar or psychotic disorder.\n* Currently in cognitive behavior therapy.\n* Change in dose of a psychiatric medication in the past 12 weeks.\n* Initiation of psychotherapy in the past 12 weeks.\n* Intent or plan to attempt suicide.",{"count":401,"type":21},60,[24],"This study aims to assess a mobile app called MAYA for use in middle-aged and older adults with anxiety or mood disorders. The MAYA app is designed to teach coping skills for anxiety and depression that are drawn from cognitive behavioral therapy. Participants will be asked to use the app for at least two days a week, 20 minutes on each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up). During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app. The main hypotheses of the study are that participants will complete most of the assigned sessions and that they will rate their impressions of the app highly. The secondary hypotheses are that symptoms of depression and anxiety will decrease with use of the MAYA app.",[405,29,27],"Anxiety Disorders and Symptoms",[311,407,408,409,27,196,410],"CBT","Mobile Application","Cognitive Behavioral Therapy","Adults",{"date":387,"type":36},{"date":413,"type":36},"2023-06-16",{"date":144,"type":21},{"name":416,"class":43},"Weill Medical College of Cornell University",{"id":418,"slug":4,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":98,"sex":17,"minAge":353,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":44},"100456159","NCT05219955","Caregiver Stress and Sleep Study","CARES","Inclusion Criteria:\n\n* Age 55 years or older.\n* Provide at least 15 hours\u002Fweek of unpaid care to a patient with a dementia diagnosis.\n* Reporting stress or strain delivering care\n* No or stable pharmacotherapy for depression\n* Meets screening definition for having morning activation difficulty or a definite morning type per the Composite Morningness Questionnaire (CMQ)\n\nExclusion Criteria:\n\n* Unsafe or unable to undergo MRI\n* Active Cognitive Behavioral Therapy for mood or insomnia\n* Probable dementia diagnosis\n* Deadly illness or plans to leave the study area\n* Current active substance use disorder",{"count":424,"type":21},120,[24],"The purpose of this research study is to better understand how stress, sleep and activity might impact caregivers' mood and brain health. This study includes a randomized experimental component where therapists will systematically deliver one of two evidence-based talk-therapy treatments. The aim is to evaluate effects on meaningful health-relevant measures including morning activation levels, depression symptoms, rumination, and aspects brain connectivity previously linked with depression. Participants will complete surveys about their caregiving experiences, health, and mood, undergo an MRI, and wear an actigraphy watch that measures activity levels throughout the day and when sleeping.",[29,428],"Caregiver Burden",[27,430,431,432],"Caregiving","Late-Life","Morningness","2026-05-15",{"date":385,"type":36},{"date":436,"type":36},"2022-07-15",{"date":438,"type":21},"2027-06-30",{"name":320,"class":43},{"id":441,"slug":4,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":17,"minAge":446,"maxAge":134,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":44},"100622454","NCT07383831","Task-Shifting Adapted IPT-A for Youth Suicide Prevention","Youth Mentor-Led Brief Interpersonal Psychotherapy for Youth Suicide Prevention","Inclusion Criteria:\n\n1. Parent consent\n2. Adolescent consent\n3. Enrolled in youth community centers\n4. Self-identified as Hispanic or Latine\n5. Between 12 and 17 years old.\n6. Scoring threshold for depression (4-9) as indicated in the PHQ-A.\n7. No current report of suicide ideation with plan or self-harming behaviors\n\nExclusion Criteria:\n\n1. Not consented to participate in the study\n2. Scoring 10 or higher in the PHQ-A, indicating depressive disorder\n3. Active suicide ideation (i.e., having thoughts of killing oneself, thinking about how in the past month).","12 Years",{"count":448,"type":21},46,[24],"The goal of this randomized pragmatic clinical trial is to examine the feasibility, acceptability, and mechanisms of change of a brief adaptation of Interpersonal Psychotherapy for Adolescents (BIPT-A), adapted and task-shifted to lay providers (mentors, youth trusted adults) in youth community centers (YCCs) as an upstream approach to suicide.\n\nIt focuses on Hispanic adolescents ages 12-17 enrolled in these YCCs. The pragmatic clinical trial will evaluate the acceptability and feasibility of adapted IPT-A delivered by mentors in YCCs and whether adapted BIPT-A impacts mechanisms of change (depressive symptoms, belongingness, and burdensomeness or feeling like a burden to others).\n\nThe main questions to answer are:\n\n* Is adapted BIPT-A, when delivered by trained lay providers (youth mentors), feasible and acceptable in youth community centers?\n* Does adapted BIPT-A, delivered by lay providers, change key risk factors (i.e., key mechanisms: depressive symptoms, low belongingness, and perceived burdensomeness) associated with suicide ideation? The investigators will compare adolescents randomized to adapted BIPT-A (6 sessions) delivered by a trained youth mentor with those receiving usual services at the community center (one individual session focused on active listening).\n\nParticipants will:\n\n1. Be screened for subthreshold depression using the Patient Health Questionnaire Adolescent version (PHQ-A). Adolescent participants will be included if they score between 4 and 9 (mild depression). Participants with a PHQ-A score of 10 or higher (severe depression) will not be eligible and will be referred to a licensed mental health provider for appropriate care.\n2. Be randomized to adapted BIPT-A or usual care. Adolescent participants in the intervention arm will participate in 6 weekly, adapted BIPT-A sessions with a trained youth mentor. Intervention focuses on education, affect identification, and interpersonal skills.",[452,29,453],"Suicidal Ideation","Adolescent Mental Health","2026-05-08",{"date":456,"type":36},"2026-05-12",{"date":458,"type":21},"2026-08-01",{"date":460,"type":21},"2028-07-31",{"name":462,"class":43},"Boston College",{"id":464,"slug":4,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":17,"minAge":446,"maxAge":18,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":44},"100531753","NCT06203899","Depression and Suicide Prevention in Adolescents Attending Special Schools","Strong Teens and Resilient Minds: School-based Depression and Suicide Prevention in Adolescents Attending Special Schools","STORM","Inclusion Criteria:\n\n* Adolescents are in their second or third year of secondary education, ór adolescents will reach the age 14 or 15 in this academic year.\n* Score above cut-off on depression symptom questionnaire (≥ 14 on the CDI-2; Bodden et al. (2016)).\n\nExclusion Criteria:\n\n* Adolescents who score 2 on item 8 of the CDI-2 or ≥ 23 on the VOZZ-screen (Kerkhof et al., 2015).\n* Clinical depression based on the clinical interview at baseline ADIS-C (Silverman \\& Albano, 1996).\n* Absence of parental permission.\n* Adolescent already receiving treatment for depressive symptomatology.\n* Insufficient knowledge of the Dutch language.",{"count":471,"type":21},236,[24],"Depression is a major public health concern. In Dutch adolescents, the prevalence of major depressive disorder is estimated at 3.8%, and one in five adolescents report depressive symptoms. Depression is a risk factor in adolescent suicide. School-based prevention programs, for example the STORM approach, are effective in decreasing depressive symptoms among adolescents with elevated depressive symptoms at screening. However, not all adolescents attend general education. In the Netherlands, 7% of all adolescents enters special education (voortgezet speciaal onderwijs and prakijkonderwijs). They form a vulnerable subgroup concerning developing depressive symptoms and suicidality. To adapt and implement programs for these students, is complex yet crucial. This study aims to screen adolescents, offer them a prevention program to prevent the onset or continuation of depression and evaluate the effectiveness of this program. It is a randomised controlled trial with two conditions. The main study parameter is depressive symptomatology. Secondary study parameters are suicidality, anxiety and somatic complaints.\n\nEligible students enter the second or third grade of special education, presenting elevated depressive symptoms. All adolescents will be screened for depressive and suicidal symptoms. Those reporting suicidality will be guided to specialised care, together with their parents. Adolescents with elevated depressive symptoms in the experimental condition will be offered the CBT-based preventive group training Op Volle Kracht in their school setting. The control condition consists of monitoring, and is offered the training if the intervention has shown to be effective. Participants will fill in longitudinal measurements. At all times, adolescents will be guided to mental health care if necessary. Furthermore, teachers in all participating schools will attend a training on how to detect and address depressive and suicidal symptoms among adolescents.\n\nThe potential value of the study is that we can offer adolescents in the special educational sector a prevention program that is proven to be effective. In order to achieve this goal we need to evaluate the effectiveness of this prevention program in this target group. We are of opinion, however, that the risks associated with participation can be considered negligible. It is specifically aimed at depressive symptoms, within a population which receives care for other problems.",[29],[27,476,477,478],"Prevention","Adolescence","Special education","2026-05-04",{"date":481,"type":36},"2026-05-07",{"date":483,"type":36},"2023-12-13",{"date":485,"type":21},"2027-08-01",{"name":487,"class":43},"Ggz Oost Brabant",{"id":489,"slug":4,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":183,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":502,"leadSponsor":504,"locationsCount":44},"100632330","NCT07512284","Mindfulness Engaged Neurostimulation for Depression (MEND II)","Mindfulness Engaged Neurostimulation for Depression","Inclusion Criteria:\n\n* Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.\n* At least one failed antidepressant medication trial at level 3 in the Antidepressant -Treatment History Form: Short Form (ATHF-SF) classification.\n* Montgomery-Åsberg Depression Rating Scale (MADRS) Score \\>19 (moderate - severe depression).\n* No increase or initiation of new antidepressant therapy in the four weeks prior to screening.\n* Demonstrated capacity to give informed consent.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Medically unstable patients.\n* Concomitant neurological disorder or a history of a seizure disorder.\n* Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Patients who are pregnant or breastfeeding.\n* Any psychotic disorder or current active psychotic symptoms.\n* Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.\n* Contraindication to MRI scanning.",{"count":424,"type":21},[357],"Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \\~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.",[27,73,74,28,29],"2026-05-01",{"date":500,"type":36},"2026-05-06",{"date":498,"type":21},{"date":503,"type":21},"2029-04-30",{"name":505,"class":43},"University of California, San Diego",{"id":507,"slug":4,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":98,"sex":17,"minAge":513,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":517,"conditions":518,"keywords":532,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":552,"locationsCount":44},"100346729","NCT03794531","Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico","Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends","PROSPECT","Inclusion Criteria:\n\n1. Age 30-75 years old at the time of enrollment\n2. Non-institutionalized\n3. Living in PR at the time of the first interview and the year before and not planning to move from the island within 3 years\n4. Able to answer questions without assistance\n5. Living in a stable dwelling\n\nExclusion Criteria:","30 Years","75 Years",{"count":516,"type":21},2500,"The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,500 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.",[519,520,521,522,523,107,524,525,363,526,527,29,528,529,530,531],"Heart Diseases","Type2 Diabetes","Hypertension","Obesity","Dyslipidemias","Cardiovascular Diseases","Chronic Disease","Psychological Stress","Physiological Stress","Coping Behavior","Diet Habit","Lifestyle","Food Insecurity",[533,534,535,536,537,538,539,540,541,542,543,544,545],"Hispanics\u002FLatinos","Minority health","Puerto Rico","Cardiovascular disease","Cardiometabolic health","Chronic disease risk factors","Disaster research","Caribbean and Latin America","Population health","Prospective study","Allostatic load","Food insecurity","Longitudinal study","2026-04-30",{"date":548,"type":36},"2026-05-05",{"date":550,"type":36},"2019-03-01",{"date":503,"type":21},{"name":553,"class":43},"Harvard School of Public Health (HSPH)",{"id":555,"slug":4,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":566,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":44},"100629196","NCT07471529","Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention","Inclusion Criteria:\n\n* indicating to seek outpatient psychotherapy\n* elevated levels of self-reported depressive symptoms (Beck Depression Inventory-II (BDI) score \\> 13 (out of 63); Kühner et al., 2007)\n* owning a smartphone\n* signing the informed consent form\n\nExclusion Criteria:\n\n* first session for outpatient psychotherapy is scheduled within four weeks\n* suicidal ideation (values \\> 2 in BDI item 9)\n* presence of manic symptoms (Mood Disorder Questionnaire (MDQ) score \\> 7), - shift work\n* age below 18 or above 70","70 Years",{"count":424,"type":21},[24],"This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.",[564,565,29],"Loneliness","Social Support",[565,564,567,568,569,29],"Just-in-Time Adaptive Intervention","JITAI","Ecological Momentary Intervention","2026-04-29",{"date":546,"type":36},{"date":573,"type":36},"2026-04-22",{"date":575,"type":21},"2026-12",{"name":577,"class":43},"University of Zurich",{"id":579,"slug":4,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":353,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":587,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":321},"100472060","NCT05426967","rTMS for Military TBI-related Depression","ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols","ADEPT","Inclusion Criteria:\n\n* Age 18-55 at the time of consent. Older individuals will not be enrolled in this initial trial for reasons of safety and expected reduced efficacy.\n* Current or former US military service member eligible for care at a Military Treatment Facility (MTF) or Veterans Administration Medical Center (VAMC.)\n* Able to provide written, informed consent in English .\n* Self-reported or medically diagnosed history of concussion (synonymous with \"mild TBI.\") \\>6 months, but \\\u003C26 years prior to consent, defined based on the DoD\u002FVA definition:\n\n  1. Positive Loss of Consciousness of \\\u003C30 minutes as confirmed by the TBI Screener and\u002For medical records and\u002For;\n  2. Positive Alteration of Consciousness of \\\u003C24 hours as confirmed by the TBI Screener and\u002For medical records and\u002For;\n  3. Positive Post-traumatic Amnesia of 0 to 1 day as confirmed by the TBI Screener and\u002For medical records.\n\n     * Note: Neuroimaging data or documentation from medical records is not required.\n* Baseline MADRS \\>13 at the time of screening indicating at least mild-moderate depressive symptoms.\n* Maintained a steady psychotropic medication regimen for six weeks and a steady behavioral therapy regimen for twelve weeks prior to enrollment in the study.\n* Female participants with child-bearing potential must agree to use an effective method of birth control during the course of the study.\n* Under the care of a primary care and\u002For behavioral health provider.\n\nExclusion Criteria:\n\n* Elevated risk of seizures at the time of rTMS including any of the following:\n\n  1. History of unprovoked seizures.\n  2. History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.\n  3. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).\n  4. History of Moderate, Severe, or Penetrating TBI based on TBI Screener and\u002For medical records.\n  5. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.\n  6. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold.\n* Contraindications to awake 3T MRI without contrast at the time of the Baseline MRI according to site radiology department criteria.\n* Severe claustrophobia interfering with medication\u002Fsedation-free 3T closed-bore MRI.\n* Intracranial lesion that would produce an artifact that would compromise the integrity of rsfMRI data.\n* History of severe or recent uncontrolled heart disease.\n* Presence of a cardiac pacemaker or intracardiac lines.\n* Any implant, prosthesis or other permanent alteration of the body (such as implanted neurostimulators and medication pumps) that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data.\n* Presence of rapidly progressive illnesses such as late-stage cancer, neurodegenerative conditions, major organ failure, etc.\n* History of Bipolar Disorder or Schizophrenia Spectrum Disorders.\n* Current evidence of substance-induced mood disorder, active psychosis, or depression secondary to general medical illness other than TBI.\n* Severe or uncontrolled substance use.\n* Concomitant or lifetime history of receiving open-label TMS, due to issues preserving blinding.\n* Concomitant or recent history (within 12 weeks prior to enrollment) of receiving other neurostimulatory treatment, including but not limited to transcranial direct current (tDCS), transcranial alternating current (tACS), alpha stim, or electroconvulsive therapy.\n* Suicide attempt within six months prior to enrollment.\n* Right upper extremity amputation or other condition precluding left motor threshold calibration.\n* Unable to complete timeline of study (e.g., planned hospitalization partway through the study period.)\n* Prisoner, or other legally restricted freedom of movement and participation.\n* Any other considerations that, in the opinion of the investigators, may adversely affect participant safety, participation, or the scientific validity of the data being collected (e.g., erratic or unreliable responses, inconsistent communication, inability to remain on a steady neurotropic medication and\u002For behavioral therapy regimen over the course of the Randomization phase of the study.)",{"count":586,"type":21},198,[24],"The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion\u002Fmild traumatic brain injury (TBI).",[29,590,591],"Mild Traumatic Brain Injury","Concussion",[593,29,591,594,595],"Transcranial Magnetic Stimulation (TMS)","Mild Traumatic Brain Injury (TBI)","Functional Magnetic Resonance Imaging (fMRI)","2026-04-24",{"date":570,"type":36},{"date":599,"type":36},"2024-12-16",{"date":601,"type":21},"2026-12-31",{"name":603,"class":43},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":605,"slug":4,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":98,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":615,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":620,"leadSponsor":621,"locationsCount":4},"100635564","NCT07554326","Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.","Rise & Thrive: Community-Engagement Intervention to Address Chronic Stress and Prevent Depression in Adolescents and Young Adults","R&T","Inclusion Criteria:\n\n1. 15-20 years old\n2. Identify as Black and\u002F or Hispanic\u002FLatine\n3. Speak English\n\nExclusion Criteria:\n\n1. Younger than 15 years old, or older than 20 years old\n2. Unable to attend the in-person sessions\n3. Non-fluent English speaker\n4. Do not identify as Black or Hispanic\u002FLatine",{"count":102,"type":21},[24],"American youth and young adults face persistent and chronic stressors, which have contributed to a mental health crisis in the United States. Four in 10 American high school students experience chronic feelings of sadness and hopelessness, 2 in 10 report suicidal ideation, and 1 in 10 attempt suicide. For adolescents and young adults, chronic stress translates to weathering, or wear and tear on the mind and body. Chronic stress in youth contributes to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death. While the connection between chronic stress and health is well documented, few studies provide evidence on innovative, non-medication strategies to reduce stress and mitigate the consequences of chronic stress on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that prevent the negative influence of chronic stress on mental and physical health, beginning in adolescence. The specific aims of the study are to 1) Determine whether a community-engagement, peer-based behavioral intervention reduces depressive symptoms in adolescents and young adults, 2) Determine whether a community-engagement behavioral intervention lowers allostatic load scores in adolescents and young adults, and 3) Identify factors that help sustain or inhibit community-engagement and intervention effects for adolescents and young adults. To accomplish these aims, the team will conduct a phase II community-engaged, peer group-based, multi-component randomized behavioral clinical trial. We will collect psychological and physiological measures at baseline, then at 6-month intervals for 2 years post-community-engaged, skills training.",[29,106,107],[109,110,111,112,113,114,115,116],"2026-04-21",{"date":618,"type":36},"2026-04-28",{"date":267,"type":21},{"date":124,"type":21},{"name":126,"class":43},{"id":623,"slug":4,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":98,"sex":17,"minAge":18,"maxAge":513,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":633,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":642,"locationsCount":44},"100623130","NCT07392632","MindfulCityU-- A Mindfulness Mobile Application for Promoting University Students' Mental Health","MindfulCityU: Implementation and Evaluation of a Mindfulness Mobile Application for Promoting University Students' Mental Health","MindfulCityU","Inclusion Criteria:\n\n(i) current undergraduate or postgraduate students; (ii) aged 18-30 years; (iii) possessing smartphone ownership and reliable internet access necessary for intervention engagement; (iv) having a score between 10-23 on the DASS-Y Depression subscale indicating a mild to moderate depressive symptom; and (v) provide informed consent\n\nExclusion Criteria:\n\n(i) students currently engaged in formal mindfulness training exceeding one session per week will be excluded to prevent confounding effects from concurrent mindfulness practice; (ii) those scoring above 23 on the DASS-Y Depression subscale, indicating severe symptoms, will be excluded and referred to appropriate clinical services to ensure their safety and access to needed care; (iii) students reporting active suicidal ideation or self-harm behaviors will be immediately referred to crisis intervention services and excluded from study participation to prioritize their safety; (iv) current engagement in psychotherapy or recent medication changes within the previous four weeks; (v) students planning to leave the university during the study period.",{"count":424,"type":21},[24],"The research aims to investigate the effectiveness a mobile phone application-based (app-based) mindfulness interventions for university students with mild depressive symptoms.\n\nThis study adopts a multicentre randomized control trial two arms research design. A randomised controlled trial will compare a newly designed mobile phone application-based (app-based) mindfulness interventions, named MindfulCityU, with a waitlist control group to determine whether the MindfulCityU produces better intervention outcomes on promoting mental health for university students, including depressive symptoms, mindfulness, and wellbeing. The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and\u002For computer. Participants of waitlist control group participants receive no active intervention at the initial stage and receive the same MindfulCityU at a later stage.\n\nParticipants will complete online standardized assessment tools on their intervention outcomes before and after the intervention and 2-months follow-up. The ethical considerations of this study were reviewed and approved by the Human and Artefacts Ethics Sub-Committee of the City University of Hong Kong in 2025.",[29],[634,635,636,27,637],"Digital Mental Health Intervention","Mobile phone application-based","Mindfulness-based Intervention","Mindfulness",{"date":596,"type":36},{"date":640,"type":21},"2026-09-01",{"date":438,"type":21},{"name":643,"class":43},"City University of Hong Kong",{"id":645,"slug":4,"hasResults":11,"nctId":646,"briefTitle":647,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":11,"sex":153,"minAge":650,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":321},"100503502","NCT05836090","Family Spirit Strengths","FSS","Inclusion Criteria:\n\n* Self-identify as female; and\n* Pregnant or be a primary caregiver of a child that is 24 months or younger; and\n* 14 years or older at time of enrollment; and\n* Report a family history of high-risk substance use and\u002For report high-risk levels of personal substance use; and\n* Have elevated symptoms of depression and\u002For anxiety and\u002For risk of substance use disorder; and\n* Be part of the service population of one of the participating sites.\n\nExclusion Criteria:\n\n* Profound disability that limits the ability to participate in assessments or interventions; and\n* Unlikely to be residing in or near the research service area for the next 6 months.","14 Years",{"count":652,"type":21},188,[24],"This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.",[29,405,656,657],"Substance Use","Mental Health Issue","2026-04-10",{"date":660,"type":36},"2026-04-13",{"date":662,"type":36},"2023-04-20",{"date":664,"type":21},"2028-06-30",{"name":666,"class":43},"Johns Hopkins Bloomberg School of Public Health",""]