[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,57,84,122,153,185,208,237,270,294,318,341,363,388,412,438,465,496,520,544,562,614,642,658,695],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100623571","medical-phenotyping-of-nhs-general-adult-psychiatry-gap-inpatients-100623571",false,"NCT07398365","Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients","Inclusion:\n\n\\- Adults aged between 18 and 65 years admitted to GAP wards during recruitment period\n\nExclusion:\n\n\\- Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)","ALL","18 Years","65 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) \"mental health\" inpatient wards, providing the first detailed information on morbidity in this patient population.",[25,26,27,28],"Bipolar Affective Disorder","Schizophrenia Disorders","Depression Disorders","Personality Disorders",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"General Adult Psychiatry","mental health","physical health","inpatients","schizophrenia","NHS","Bipolar affective disorder","depression","psychosis","treatment resistance","personality disorder","cardiometabolic disease","cancer","respiratory disease","RECRUITING","2026-06-30",{"date":47,"type":48},"2026-07-01","ACTUAL",{"date":50,"type":48},"2024-04-03",{"date":52,"type":21},"2026-12-31",{"name":54,"class":55},"University of Edinburgh","OTHER",1,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":56},"100585844","couples-affect-in-relationships-study-100585844","NCT06907654","Couples' Affect in Relationships Study","Cares","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Be either married, living together, OR in a dating relationship for at least 12 months\n* Proficiency in English\n* US citizen or permanent resident\n* If non-monogamous, must be able to enroll in the study with a primary partner with whom they spend the majority of their time.\n* Use of a smartphone (primary participant only)\n* Phone able to receive SMS text messages\n* Depression symptoms (≥ 5 on PHQ-9; primary participant only)\n\nExclusion Criteria:\n\n* Severe physical or sexual relationship aggression during the past 6 months (any item endorsement on 5-item severe IPV screener)\n* Endorsement of active suicidality\n* History of psychosis or mania\n* Prior use of the Healthy Minds Program app\n* Prior significant experience with meditation\n* Severe hearing impairment that would interfere with the use of an audio-based intervention (primary participant only)",true,{"count":66,"type":21},2000,"INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is:\n\n* Does gaining knowledge about well-being positively impact individuals and their romantic relationships?\n\nParticipants will complete online surveys about their thoughts and feelings.",[27],[73,74],"romantic relationship","long-term relationship","NOT_YET_RECRUITING","2026-06-29",{"date":47,"type":48},{"date":79,"type":21},"2026-07",{"date":81,"type":21},"2028-12",{"name":83,"class":55},"University of Wisconsin, Madison",{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":67,"phases":95,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":121},"100577061","phase-3-a-study-of-a-deuterated-psilocin-analog-cyb003-in-humans-with-major-depressive-disorder-100577061","NCT06793397","A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder","An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder","EMBRACE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.\n* Participant has a body mass index (BMI) of 40 kg\u002Fm2 or less (BMI ≤40 kg\u002Fm2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.\n* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.\n* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded from trial participation:\n\n* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.\n* Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.","85 Years",{"count":94,"type":21},330,[96],"PHASE3","The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.\n\nFor more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https:\u002F\u002Fembrace-mdd-trial.com\u002F",[99,100,101,27,102,103],"Major Depressive Disorder (MDD)","Depression in Adults","Depression - Major Depressive Disorder","Depression Disorder","Depression",[105,106,103,107,108,109,110,111,112],"MDD","Psychedelic","Major Depressive Disorder","CYB003","CYB003-001","CYB003-002","Psilocybin","psilocin-7438",{"date":45,"type":48},{"date":115,"type":48},"2025-12-10",{"date":117,"type":21},"2027-05-08",{"name":119,"class":120},"Cybin IRL Limited","INDUSTRY",68,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":64,"sex":16,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":67,"phases":133,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":56},"100638259","brief-intervention-addressing-stigma-among-parents-of-children-with-mental-health-problems-100638259","NCT07594730","Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems","RCT of Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems","Inclusion Criteria:\n\n* Self-identify as English Speaking\n* Live in the US\n* Ages 25-50\n* Have a child 6-18 years old with either depression, ADHD, or a substance use problem\n\nExclusion Criteria:\n\n* Do not speak English\n* Do not live in the US\n* \\\u003C25 or \\>50\n* Do not have a child between ages 6-18 with depression, ADHD, or a substance use problem","25 Years","50 Years",{"count":132,"type":21},1600,[69],"The goal of this study is to test the efficacy of brief video interventions parental internalized stigma and stigma-related outcomes (e.g., treatment intentions, caregiver burden, secrecy) among parents (ages 25-50) of children ages 6-18 with depression, ADHD, or substance use problems.\n\nTimely identification and treatment of mental health problems in youth is a public health priority. However, many youth do not receive treatment, and stigma has been identified as the primary barrier to help-seeking. Parents experience stigma related to their children having mental health problems, which has been associated with reduced help-seeking and increased parental distress. Prior experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of \"social contact\" with individuals affected by a stigmatized condition, effective in reducing mental health stigma and increasing help-seeking.\n\nIn this 4-arm RCT, the investigators will recruit parents aged 25-50 using an online crowdsourcing platform, to test the efficacy of BVIs featuring a personal parent narrative of their experience with their child's a) depression, b) ADHD, or c) substance use, or d) a control condition that provides general written psychoeducational information without social contact.",[27,136,137,138,139,140],"ADHD","Substance Abuse","Social Stigma","Help-Seeking Behavior","Caregiver Burden",[142,143,144],"social stigma","help-seeking behavior","caregiver burden","2026-06-26",{"date":45,"type":48},{"date":148,"type":21},"2026-07-06",{"date":150,"type":21},"2026-09-06",{"name":152,"class":55},"New York State Psychiatric Institute",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":67,"phases":163,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":56},"100596878","recovery-through-inspiration-support-and-empowerment-100596878","NCT07051200","Recovery Through Inspiration, Support, and Empowerment","RISE","Inclusion Criteria:\n\n* Chief complaint of suicidal ideation, suicide attempt, depression, and\u002For anxiety\n* discharged from inpatient care or from emergency department\n* men and women ages 18-27\n\nExclusion Criteria:\n\n* primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)","27 Years",{"count":162,"type":21},40,[69],"The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.\n\nThe current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources.\n\nThe intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO).\n\nParticipants will be assigned to either Cohort A or B for 8 weeks.\n\nCohort A will be the intervention group with PSS and RCOs.\n\n* Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4.\n* Weeks 5 and 7: One-on-one meetings with PSS for education and support.\n* Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks.\n\nCohort B will be the SOC group with no PSS or RCOs.\n\n* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4.\n* Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8.\n\nData collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.",[166,167,168,27],"Suicidal Ideation","Suicide Attempt","Anxiety",[170,171,172,173,174,175],"Peer Support Specialist (PSS)","Recovery Community Organization (RCO)","Mental Health Recovery","Transitional Age Youth (TAY)","UT Southwestern Medical Center","Young Adult","2026-06-22",{"date":178,"type":48},"2026-06-25",{"date":180,"type":48},"2025-04-01",{"date":182,"type":21},"2027-12-01",{"name":184,"class":55},"University of Texas Southwestern Medical Center",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":16,"minAge":193,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":56},"100585717","visual-rehabilitation-and-depression-in-visually-impaired-patients-with-amd-100585717","NCT06906003","Visual Rehabilitation and Depression in Visually Impaired Patients With AMD","Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients With Advanced Age Related Macular Degeneration","RET 06-24","Inclusion Criteria:\n\n1. Subjects ≥ 55 years\n2. Moderate and severe visual impairment (BCVA ≥1\u002F10 and ≤2\u002F10)\n3. Diagnosis of advanced non-exudative age-related macular degeneration (AMD)\n4. Informed consent freely granted and acquired before the start of the study\n5. Ability to understand and willingness to follow the study instructions and procedures\n\nExclusion Criteria:\n\n1. Visual impairment due to other ocular diseases\n2. Mild visual impairment or partial or total blindness\n3. Exudative age-related macular degeneration undergoing intravitreal drug treatment","55 Years",{"count":195,"type":21},22,"Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status.\n\nStudy design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia.\n\nStudy procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9).\n\nVisit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings.\n\nVisit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety.",[198,168,27],"AMD - Age-Related Macular Degeneration","2026-05-29",{"date":201,"type":48},"2026-06-01",{"date":203,"type":48},"2024-12-02",{"date":205,"type":21},"2026-12-02",{"name":207,"class":55},"Fondazione G.B. Bietti, IRCCS",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":67,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100585148","enhancing-engagement-by-integrating-goals-and-concerns-that-matter-to-patients-100585148","NCT06898593","Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients","Inclusion Criteria:\n\n* Patients enrolled in the Collaborative Care Model (CoCM) at Dartmouth Health\n\nExclusion Criteria:\n\n* Patients not enrolled in the Collaborative Care Model (CoCM) at Dartmouth Health","100 Years",{"count":216,"type":21},2448,[69],"The goal of this clinical trial is to learn if adding patients' goals and concerns to measurement-based collaborative care can tailor care and provide a more holistic view of treatment, thereby improving engagement in care among adult patients receiving collaborative care. The main questions it aims to answer are:\n\n* Does using a clinical decision support system (which includes an enhanced pre-visit questionnaire and patient-level dashboard) improve patient engagement in the collaborative care model?\n* Does using a clinical decision support system improve patient and clinician satisfaction with care?\n\nResearchers will compare the enhanced collaborative care with traditional collaborative care.\n\nPatient participants will complete pre-visit questionnaires before their collaborative care appointments. Responses will be viewed by the clinician and\u002For patient in a visual dashboard inside the electronic health record.",[220,27],"Anxiety Disorders",[222,223,224,225,103,168,226],"Collaborative Care Model","pre-visit questionnaire","dashboard","clinical decision support system","integrated behavioral health and primary care","2026-04-27",{"date":229,"type":48},"2026-04-29",{"date":231,"type":48},"2025-04-02",{"date":233,"type":21},"2028-07-31",{"name":235,"class":55},"Dartmouth-Hitchcock Medical Center",6,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":67,"phases":246,"briefSummary":247,"conditions":248,"keywords":253,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":56},"100634918","single-arm-monocentric-pilot-feasibility-study-on-an-interactive-virtual-reality-program-in-20-complex-in-clinic-palliative-care-patients-100634918","NCT07545928","Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients","ZENCTUARY_VR+","Inclusion Criteria:\n\n* Patient ≥ 18 years old, hospitalized at the USP - HUS\n* Estimated life expectancy ≥ 1 month (Pronopall score based on clinical data).\n* Montreal Cognitive Assessment (MoCA) scale score ≥ 26.\n* Able to understand the objective and risks of the study\n* VRISE score ≤ 25 after the VR familiarization procedure\n* Affiliation with the Social Security system or beneficiary of such social protection.\n* Signed consent from, able to understand and complete the questionnaires in French.\n\nExclusion Criteria:\n\n* Patients with psychiatric disease\n* Patients under court protection\n* Uncontrolled epilepsy\n* Visual impairments (lack of binocular vision, blindness) and\u002For hearing impairments (deafness) preventing the use of virtual reality",{"count":245,"type":21},20,[69],"Palliative care patients frequently face a \"symptom cluster\" of pain (up to 96%), fatigue (up to 90%), and anxiety (up to 79%), which severely degrades their quality of life in their final months.The study is built on the concept of passive exposure therapy (VREP), which engages multiple senses to distract the brain from pain signals. By creating an \"immersive distraction\" or a \"flow state,\" VR can activate the brain's reward networks and reduce activity in areas associated with pain perception. Unlike most existing VR research in palliative care which uses \"passive\" VR (like watching a 360-degree video), this study uses interactive VR. Patients can perform simple actions-like grabbing or dropping virtual objects-within a calming natural environment, which may better support their sense of autonomy and dignity. Because this is a pilot study, the \"Go\u002FNo-Go\" decision for future larger trials depends on a strict composite of three factors:\n\n* Adherence: The patient must complete at least 11 out of 14 planned daily sessions.\n* Duration: Each session must average at least 7.5 minutes of usable VR exposure.\n* Tolerance: The patient must experience no device-related serious adverse events and maintain a high average tolerance score (VRISE score ≥ 25).",[249,250,168,27,251,252],"Palliative Care","Refractory Pain","Fatigue, Mental","Psychological Distress",[254,255,256,257,258,259,260],"palliative care","end-of-life care","refractory pain","Interactive Virtual Reality","Immersive Technology","Virtual Reality Exposure Therapy (VRET)","Cybersickness in Palliative Care","2026-04-15",{"date":263,"type":48},"2026-04-22",{"date":265,"type":21},"2026-09-01",{"date":267,"type":21},"2027-03-01",{"name":269,"class":55},"University Hospital, Strasbourg, France",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":67,"phases":280,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":292,"locationsCount":56},"100606391","phase-2-ssri-antidepressant-fluoxetine-improving-immunotherapy-efficacy-in-advanced-hepatobiliary-malignancy-patients-with-depression-and-anxiety-100606391","NCT07174947","SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety","SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age: 18 to 80 years old, both male and female are acceptable.\n* The histopathological\u002Fcytological diagnosis is hepatocellular carcinoma or cholangiocarcinoma. Hepatocellular carcinoma can be diagnosed by imaging.\n* Patients with metastatic advanced or locally advanced liver and gallbladder malignancies;\n* No treatment has been received and a first-line treatment regimen including PD-1 inhibitors \u002FPD-L1 inhibitors is planned to be carried out;\n* Patients with a PHQ-9 score of ≥10 or a GAD-7 score of ≥8, that is, those with positive screening for depression or anxiety;\n* At least one lesion measurable by CT or MRI (with a maximum diameter of ≥0.5cm);\n* ECOG: 0-2;\n* Child-Pugh score ≤7 points;\n* The expected survival period is ≥12 weeks.\n* Baseline blood cell count tests and blood biochemistry must meet the following standards:1) White blood cell count ≥3.0×10\\^9\u002FL; Hemoglobin ≥90 g\u002FL;2) Absolute neutrophil count ≥1.5×10\\^9\u002FL;3) Platelet count ≥100×10\\^9\u002FL;4) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of the normal upper limit (ULN);5) Total bilirubin ≤ twice ULN;6) Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g\u002FL;\n* The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n\nExclusion Criteria:\n\n* Those with uncorrectable coagulation dysfunction and a distinct bleeding tendency;\n* Patients who currently have unstable or active ulcers or gastrointestinal bleeding;\n* Severe functional insufficiency of vital organs, such as severe cardiopulmonary insufficiency, etc;\n* Patients with hepatic encephalopathy or intractable ascites requiring treatment;\n* A history of mental disorders such as bipolar disorder, schizophrenia, and active suicidal ideation;\n* Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active is defined as a viral load \\> 20,000 IU\u002FmL), or those who are positive for HBV or HCV and refuse to receive standardized antiviral treatment;\n* Unable to swallow oral medication;\n* Patients allergic to fluoxetine;\n* Currently using drugs that may have serious interactions with fluoxetine;\n* The researchers assessed that the patient was unable or unwilling to comply with the requirements of the research protocol.","80 Years",{"count":279,"type":21},240,[281],"PHASE2","Advanced liver and gallbladder malignancies (including liver cancer, cholangiocarcinoma and gallbladder cancer) are a type of disease that is difficult to treat, and most patients have a short survival period. In recent years, immunotherapy (such as PD-1\u002FPD-L1 inhibitors) has brought new hope to these patients, but still only a small number of patients can benefit.\n\nResearch has found that approximately 40% of patients with liver and gallbladder tumors have symptoms of depression and anxiety, which not only affect their quality of life but may also reduce the therapeutic effect by influencing immune function. Fluoxetine is a commonly used antidepressant. The latest research shows that in addition to improving mood, it may also enhance the anti-tumor effect of immunotherapy. This study aims to explore whether fluoxetine combined with immunotherapy can better control tumors than immunotherapy alone, prolong the survival period of patients, and at the same time improve the depressive and anxious symptoms and quality of life of patients.",[284,285,220,27],"Hepatobiliary Malignancy","Fluoxetine","2026-03-20",{"date":288,"type":48},"2026-03-24",{"date":290,"type":48},"2025-10-01",{"date":182,"type":21},{"name":293,"class":55},"First Affiliated Hospital of Wenzhou Medical University",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":67,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":56},"100619476","cost-effectiveness-and-implementation-of-a-transdiagnostic-internet-based-intervention-for-emotional-disorders-in-community-care-100619476","NCT07345117","Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Community Care.","From Research to Clinical Practice: Implementation of an Internet-based Transdiagnostic Treatment Program for Emotional Disorders in Primary Care (TREAT-ED)","TREAT-ED","Patient Inclusion Criteria:\n\n* Over 18 years of age.\n* Meet the diagnostic criteria for an anxiety or depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n* Understand and read Spanish or Catalan.\n* Have access to the Internet and an email address\n* Give informed consent.\n\nPatient Exclusion Criteria:\n\n* Diagnosis of schizophrenia, bipolar disorder, or alcohol or substance dependence.\n* High risk of suicide.\n* Presence of a medical condition that prevents psychological treatment.\n* Receiving other psychological treatment (other than TAU or the online program) during the study.\n* For participants in the online treatment condition with pharmacological treatment, this must be stabilized (doses cannot be changed or increased during the study, only reduced).\n\nInclusion Criteria for mental health Professionals:\n\n* They work at centers participating in the study.\n* They agree to participate in the study.\n* They sign an informed consent form.",{"count":303,"type":21},200,[69],"Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.",[307,308,27,220],"Emotional Disorders","Depression Anxiety Disorder","2026-03-17",{"date":311,"type":48},"2026-03-18",{"date":313,"type":21},"2026-04-01",{"date":315,"type":21},"2029-01-01",{"name":317,"class":55},"Universitat Jaume I",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":56},"100570093","prevalence-and-severity-of-depression-among-cardiothoracic-surgery-healthcare-workers-in-baghdad-a-phq-9-cross-sectional-study-100570093","NCT06702761","Prevalence and Severity of Depression Among Cardiothoracic Surgery Healthcare Workers in Baghdad: A PHQ-9 Cross-Sectional Study","Assessing the Prevalence and Severity of Depression Among Cardiothoracic Surgery Healthcare Workers in Baghdad Using the PHQ-9: A Cross-Sectional Study","DEPRESS\u002FPHQ-9","Inclusion Criteria:\n\n* Healthcare professionals actively working in cardiothoracic surgery departments in Baghdad, including surgeons, anesthesiologists, nurses, and support staff.\n* Participants who provide informed consent for participation in the study.\n* Able to complete questionnaire form.\n\nExclusion Criteria:\n\n* Individuals with a previously diagnosed psychiatric condition other than depression that could confound the results.\n* Incomplete or missing responses on the PHQ-9 questionnaire.\n* Refusal to provide informed consent.\n* Participants are currently undergoing treatment for depression or other mental health conditions.\n* Healthcare workers on long-term leave or who have not actively worked in the cardiothoracic surgery department for the past 3 months.",{"count":303,"type":21},"This observational study aims to estimate the prevalence and severity of depression in HCWs in cardiothoracic surgery departments in Baghdad City, Iraq, using a self-administered PHQ-9 questionnaire. The main questions it aims to answer are:\n\nWhat is the prevalence of depression among cardiothoracic surgery healthcare workers? How is the severity of depression distributed within this group? Are there specific occupational or demographic factors associated with higher levels of depression?\n\nParticipants will:\n\nFill out the PHQ-9 in order to measure the severity of depressive symptoms at a specific moment in time.\n\nDemographic and occupational details such as age, gender, years of experience and position held should be taken to look for possible relationship with depression.",[27],[330,331],"PHQ-9","HCWs","2026-03-03",{"date":334,"type":48},"2026-03-04",{"date":336,"type":48},"2024-12-01",{"date":338,"type":21},"2026-12-15",{"name":340,"class":55},"Al-Nahrain University",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":347,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":67,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100609171","improving-the-treatment-of-depression-among-youth-with-hiv-100609171","NCT07211087","Improving the Treatment of Depression Among Youth With HIV","Inclusion Criteria:\n\n* aged 15- 24 years\n* engaged in care at a participating HIV care site\n* have documented HIV-1 confirmed by medical records\n* a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment \\[either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)\n* significant symptomatology at Entry (as defined by the PHQ-9)\n* aware of their HIV status as determined by site staff\n* English-speaking\n* able and willing to provide written informed assent\u002Fconsent and written parental or guardian permission\n\nExclusion Criteria:\n\n* by site review, have a history of any psychotic disorders and\u002For Bipolar I or II Disorder\n* have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment\n* have depression and\u002For suicidal ideation requiring more intensive services\n* intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist)\n* if they are in imminent danger to themselves or others. If wards of the state meet all eligibility requirements, they will be eligible if the state allows them to participate in research. Otherwise, they will be excluded.","15 Years","24 Years",{"count":350,"type":21},130,[69],"Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness.\n\nThis proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.",[27,354],"HIV (Human Immunodeficiency Virus)","2026-02-25",{"date":357,"type":48},"2026-02-27",{"date":313,"type":21},{"date":360,"type":21},"2029-07-01",{"name":362,"class":55},"Rhode Island Hospital",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"100609721","ai-platform-for-fatigue-and-depression-detection-100609721","NCT07218263","AI Platform for Fatigue and Depression Detection","Efficacy of a Novel Web-based Fatigue and Cognitive Assessment Platform in Detecting Fatigue and Depression","Inclusion Criteria:\n\n* Age ≥18, English-speaking, able to consent\n\nExclusion Criteria:\n\n* Active substance use, nonverbal, cognitive disability, active suicidal\u002Fhomicidal ideation","99 Years",{"count":20,"type":21},"This observational study evaluates the accuracy of the Okaya AI platform in detecting fatigue and depression in cardiology patients, comparing its assessments to PHQ-9 and Fatigue Assessment Scale scores.",[27,374,375],"Fatigue Symptom","Cardiovascular",[377,103,378],"Fatigue","Artificial Intelligence","2026-02-23",{"date":355,"type":48},{"date":382,"type":48},"2025-12-01",{"date":384,"type":21},"2026-05",{"name":386,"class":55},"Brijesh Patel",2,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":56},"100622888","evaluate-the-effects-of-long-term-use-of-psychotropic-medications-on-eye-movement-patterns-with-the-gaize-device-100622888","NCT07389473","Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device","An Observational Study to Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device","Rx Meds Gaize","Inclusion Criteria:\n\n* Adults aged between 18 and 65, having given written informed consent to participate in the research trial.\n* Currently using a psychiatric medication as prescribed by a healthcare professional for longer than 3 months.\n* Normal or corrected to normal vision using either glasses or contact lenses, or surgery.\n\nExclusion Criteria:\n\n* Enrolled in, or participated in another clinical trial within 30 days before the study\n* Having a prosthetic eye, missing eye, or wearer of an eye patch LASIK or other eye surgery within the prior 21 days.\n* Had your eyes dilated by a medical doctor in the previous 24 hours.\n* Photosensitive epilepsy\n* Diagnosed with clinical blindness\n* Medical Conditions: Participants with medical conditions or medications that could significantly affect cognitive and motor functions are excluded. Participants with conditions such as Glaucoma, macular degeneration, cataracts, lazy eye (amblyopia), or optic neuritis, or genetic anisocoria (unequal pupil size) will be excluded.\n* Current or past head inject\u002F traumatic brain injury (TBI)\n* Pregnancy: Pregnant individuals will be excluded from the study due to the potential risks associated with psychiatric medications.\n* History of Severe Motion Sickness: Participants with a history of severe motion sickness in VR environments may be excluded, as they may not tolerate the VR headset well.\n* Potential participants who are unable to provide consent for the study.",{"count":397,"type":21},50,"The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.",[136,27,400,401,402],"Mood Disorders","Anxiety Disorder Generalized","Bipolar Disorder (BPD)","2026-02-04",{"date":405,"type":48},"2026-02-05",{"date":407,"type":48},"2024-04-17",{"date":409,"type":21},"2028-08",{"name":411,"class":120},"Gaize",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":16,"minAge":347,"maxAge":17,"enrollmentInfo":420,"targetDuration":4,"studyType":67,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":56},"100606062","teen-recovery-through-inspiration-support-and-empowerment-100606062","NCT07170657","Teen Recovery Through Inspiration, Support, and Empowerment","Teen Recovery Through Inspiration, Support, and Empowerment (RISE)","Teen RISE","Inclusion Criteria:\n\n* Chief complaint of suicidal ideation, suicide attempt, depression, and\u002For anxiety\n* recently discharged from inpatient care or from emergency department\n* men and women ages 15-18 years old\n\nExclusion Criteria:\n\n\\- primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)",{"count":162,"type":21},[69],"The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program.\n\nThe current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.\n\nThe intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS).\n\nParticipants will be assigned to either Cohort A or B for 8 weeks.\n\nCohort A will be the intervention group with online access to an RES, TP, and PSS.\n\n* Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4.\n* Week 5 and 7: one-one meetings with PSS and TP for education and support.\n* Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8.\n\nCohort B will be the SOC group with no PSS, TP, or RES.\n\n* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4.\n* Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8.\n\nData collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.",[166,167,168,27],[170,425,426,427,174,172,428,429],"Recovery Education and Support (RES) Program","Teenage","High School Teen","Online","Virtual","2026-01-28",{"date":432,"type":48},"2026-01-30",{"date":434,"type":48},"2025-11-05",{"date":436,"type":21},"2026-11",{"name":184,"class":55},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":67,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":56},"100567979","meditative-neurofeedback-for-depression-100567979","NCT06675240","Meditative Neurofeedback for Depression","MediNF","Inclusion Criteria:\n\n* moderate depression per PHQ9 symptom ratings\n\nExclusion Criteria:\n\n* active substance abuse\u002Fdependence\n* psychotic disorders\n* bipolar disorder\n* displaying acutely suicidal behaviors",{"count":446,"type":21},27,[69],"The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.",[101,27],[451,452,453,454,455,37],"meditation","neurofeedback","rumination","EEG","anxiety","2026-01-12",{"date":458,"type":48},"2026-01-14",{"date":460,"type":48},"2024-11-15",{"date":462,"type":21},"2027-06-15",{"name":464,"class":55},"University of California, San Diego",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":473,"enrollmentInfo":474,"targetDuration":475,"studyType":22,"phases":4,"briefSummary":476,"conditions":477,"keywords":483,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":56},"100617151","psychiatric-status-and-symptom-severity-in-graft-versus-host-disease-gvhd-100617151","NCT07314892","Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).","Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).","Psych-GvHD","Inclusion Criteria:\n\n* Adult patients with a clinically established diagnosis of graft-versus-host disease (GvHD) receiving specialist follow-up care at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK), Gdańsk.\n\nExclusion Criteria:\n\n* Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.","75 Years",{"count":303,"type":21},"1 Year","This prospective observational study evaluates the association between psychiatric status, GvHD-related symptom severity, and health-related quality of life in patients with graft-versus-host disease. Standardized and validated assessment tools, including the Lee Symptom Scale, will be used to collect psychiatric, clinical, and demographic data.",[478,479,480,481,27,482],"GVHD, Chronic","GVHD - Graft-Versus-Host Disease","GVHD","Quality of Life","Cognitive Impairments",[484,37,485,486],"GvHD","quality of life","Cognitive impairment","2025-12-18",{"date":489,"type":48},"2026-01-02",{"date":491,"type":48},"2025-04-08",{"date":493,"type":21},"2028-10",{"name":495,"class":55},"Medical University of Gdansk",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":67,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":56},"100614998","enhanced-ward-rounds-and-communication-for-pre-procedural-anxiety-in-gi-endoscopy-patients-100614998","NCT07286877","Enhanced Ward Rounds and Communication for Pre-procedural Anxiety in GI Endoscopy Patients","Enhanced Ward-Round Frequency With Standardized Communication for Pre-procedural Anxiety in Hospitalized Patients Undergoing Therapeutic Gastrointestinal Endoscopy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD\u002FEMR, therapeutic colonoscopy).\n3. Able to provide informed consent and complete required assessments.\n\nExclusion Criteria:\n\nEmergency\u002Fimmediate endoscopy required.\n\n1. Severe cognitive impairment or psychotic disorder affecting assessments. Isolation\u002Fsingle room preventing protocol implementation.\n2. Unable to complete the primary pre-procedure assessment within the 2-4 hour window.",{"count":504,"type":21},1000,[69],"This study tests a new way to help reduce anxiety in hospitalized patients waiting for therapeutic gastrointestinal (GI) endoscopy procedures, like EMR or ESD. Anxiety before these procedures is common and can make preparation harder, increase medication needs, and affect recovery.\n\nWe compare standard ward checks (twice a day) to enhanced checks (four times a day) with structured talks and simple relaxation exercises. The goal is to see if the enhanced approach lowers anxiety levels, measured by a standard scale called the Hamilton Anxiety Rating Scale (HAM-A), from baseline to 24 hours before the procedure.\n\nWho can join? Adults (18+) scheduled for inpatient GI endoscopy with at least 2 days hospital stay and mild anxiety. Exclusions include emergencies or severe mental health issues.\n\nThe study is done in hospital wards, with groups assigned by ward periods to keep it real-world. Benefits may include less anxiety and better experience; risks are low as it's just more supportive talks. Participation is voluntary with informed consent. Results could improve hospital care routines.",[168,27,508,509,510],"Sleep Wake Disorders","Gastrointestinal Diseases","Preoperative Anxiety","2025-12-13",{"date":513,"type":48},"2025-12-16",{"date":515,"type":21},"2026-01-15",{"date":517,"type":21},"2027-02-20",{"name":519,"class":55},"LanZhou University",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":56},"100614394","validate-the-temporal-stability-and-responsiveness-of-ai-coa-for-depression-and-anxiety-100614394","NCT07279025","Validate the Temporal Stability and Responsiveness of AI-COA® for Depression and Anxiety","Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment","SEQUOIA-2","Inclusion Criteria:\n\n* English fluency\n* 18 to 65 years of age.\n* HAM-D 17 \\> 10\n* Starting, or has started, a new treatment for depression or anxiety within 2-3 weeks of enrollment\n* Access to a laptop or other computer with a well functioning microphone and webcam, and a stable Internet connection\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Resides in the United States at the time of consent and during completion of study\n\nExclusion Criteria:\n\n* Any cognitive impairment that limits ability to provide informed consent or authorization\n* Vulnerable or protected populations (e.g. prisoners)\n* Impairment that would prevent participants from completing an online survey and\u002For engaging in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment)\n* Acute intoxication at the time of the assessments\n* Concurrent medication\u002Ftreatment:\n\n  * Receiving any fast-acting treatment for depression or anxiety (e.g. ketamine, psychedelics, deep brain stimulation, etc.) in between initial baseline assessment (A1) and Restest (A2) , or in between Follow up assessment (B1) and Retest (B2)\n  * Anxiolytics: Use of benzodiazepines or other anxiety-reducing medications that could affect speech or motor activity, within the past 4 weeks.\n  * Antipsychotics and Mood Stabilizers: Medications that can alter cognitive and motor functions, within the past 6 weeks.\n  * Stimulants: Use of medications like methylphenidate or amphetamines that affect energy levels and behavior, within the past 2 weeks\n  * Epilepsy medication: seizure activity or medication side effects that may alter behavior, within the past 4 weeks.\n* Any history or evidence of any of the following conditions:\n\n  * Neurodevelopmental, Neurocognitive, Neurodegenerative or movement disorders including, but not limited to:\n  * Tourette's syndrome\n  * Multiple Sclerosis\n  * Amyotrophic Lateral Sclerosis\n  * Parkinson's Disease\n  * Stroke\n  * Traumatic Brain Injury\n  * Facial paralysis.\n* Conditions with vocal cord impact:\n\n  * Vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year\n  * Disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia\n  * Past or active heavy smokers (an average of \\>20 cigarettes per day)\n* Schizophrenia Spectrum and Other Psychotic Disorders:\n\n  * Individuals with a current or past diagnosis of Schizophrenia, Schizoaffective Disorder, or other psychotic disorders, including Delusional Disorder and Brief Psychotic Disorder.\n  * Current hypomanic episode as defined by DSM-5 criteria. This includes those with Bipolar I Disorder, Bipolar II Disorder, or Cyclothymic Disorder who are not in a stable mood state at the time of assessment.\n  * Chronic Pain Conditions: Such as fibromyalgia, which may affect facial expressions and vocal tone.\n  * Prosthetic Facial Devices: Could affect facial recognition algorithms. Cosmetic Procedures: Such as Botox injections or facelifts that can impact facial expressions.\n  * Dental Work: Major procedures that might affect speech.\n* Participants who have previously participated in another research project by Deliberate.",{"count":529,"type":21},150,"This study evaluates the reliability and responsiveness of the AI-COA®, a digital tool designed to assess the severity of depression and anxiety. The study compares the tool's performance against standard clinician ratings over 12 weeks to determine its consistency and sensitivity to symptom changes.",[27,220],[533,534],"depression assessment","anxiety assessment","2025-12-07",{"date":537,"type":48},"2025-12-12",{"date":539,"type":21},"2026-03-01",{"date":541,"type":21},"2027-02-28",{"name":543,"class":120},"Deliberate Solutions Inc.",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":559,"leadSponsor":561,"locationsCount":56},"100614395","pivotal-us-clinical-validation-of-ai-coa-for-depression-and-anxiety-100614395","NCT07279038","Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety","Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase","SEQUOIA-3","Inclusion Criteria:\n\n* English fluency\n* 18 to 65 years of age.\n* Diagnosed with MDD or MDE (Includes Remission, HAM-D \\\u003C= 7)\n* Starting, or has started, a new treatment for depression or anxiety within 2-3 weeks of enrollment\n* Access to a laptop or other computer with a well functioning microphone and webcam, and a stable Internet connection\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Resides in the United States at the time of consent and during completion of study\n\nExclusion Criteria:\n\n* Any cognitive impairment that limits ability to provide informed consent or authorization\n* Vulnerable or protected populations (e.g. prisoners)\n* Impairment that would prevent participants from completing an online survey and\u002For engaging in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment)\n* Acute intoxication at the time of the assessments\n* Concurrent medication\u002Ftreatment:\n\n  * Receiving any fast-acting treatment for depression or anxiety (e.g. ketamine, psychedelics, deep brain stimulation, etc.) in between initial baseline assessment (A1) and Restest (A2) , or in between Follow up assessment (B1) and Retest (B2)\n  * Anxiolytics: Use of benzodiazepines or other anxiety-reducing medications that could affect speech or motor activity, within the past 4 weeks.\n  * Antipsychotics and Mood Stabilizers: Medications that can alter cognitive and motor functions, within the past 6 weeks.\n  * Stimulants: Use of medications like methylphenidate or amphetamines that affect energy levels and behavior, within the past 2 weeks\n  * Epilepsy medication: seizure activity or medication side effects that may alter behavior, within the past 4 weeks.\n* Any history or evidence of any of the following conditions:\n\n  * Neurodevelopmental, Neurocognitive, Neurodegenerative or movement disorders including, but not limited to:\n  * Tourette's syndrome\n  * Multiple Sclerosis\n  * Amyotrophic Lateral Sclerosis\n  * Parkinson's Disease\n  * Stroke\n  * Traumatic Brain Injury\n  * Facial paralysis.\n* Conditions with vocal cord impact:\n\n  * Vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year\n  * Disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia\n  * Past or active heavy smokers (an average of \\>20 cigarettes per day)\n* Schizophrenia Spectrum and Other Psychotic Disorders:\n\n  * Individuals with a current or past diagnosis of Schizophrenia, Schizoaffective Disorder, or other psychotic disorders, including Delusional Disorder and Brief Psychotic Disorder.\n  * Current hypomanic episode as defined by DSM-5 criteria. This includes those with Bipolar I Disorder, Bipolar II Disorder, or Cyclothymic Disorder who are not in a stable mood state at the time of assessment.\n  * Chronic Pain Conditions: Such as fibromyalgia, which may affect facial expressions and vocal tone.\n  * Prosthetic Facial Devices: Could affect facial recognition algorithms. Cosmetic Procedures: Such as Botox injections or facelifts that can impact facial expressions.\n  * Dental Work: Major procedures that might affect speech.\n* Participants who have previously participated in another research project by Deliberate.",{"count":553,"type":21},650,"This study is a large-scale pivotal clinical validation of the AI-COA® software device. The purpose is to confirm the tool's accuracy and performance across a demographically diverse population of adults with Major Depressive Disorder (MDD), ensuring it functions fairly and reliably across different subgroups.",[27,220],[533,534],{"date":537,"type":48},{"date":267,"type":21},{"date":560,"type":21},"2029-08-28",{"name":543,"class":120},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":277,"enrollmentInfo":569,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":571,"conditions":572,"keywords":590,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":613},"100609246","precision-subclassification-of-mental-health-in-diabetes-digital-twins-for-precision-mental-health-to-track-subgroups-100609246","NCT07212075","Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups","TwinPeaks","Inclusion Criteria:\n\n* 18 to 80 years of age\n* Diagnosis of type 1 diabetes or type 2 diabetes or other specific type of diabetes\n* Diabetes duration ≥ 1 year\n* Sufficient German language skills\n* Informed consent\n\nExclusion Criteria:\n\n* Inability to consent\n* Significant cognitive impairment (e.g. dementia)\n* Severe disorder or condition impacting the person's ability to participate in the study or likely to confound results (e.g. treated cancer, heart disease ≥ NYHA III, schizophrenia\u002Fpsychotic disorder)\n* Terminal illness\n* Being bedridden",{"count":570,"type":21},1809,"Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health.\n\nBelonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups.\n\nOver 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person.\n\nThe objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions.\n\nTo achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews.\n\nThe complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.",[573,574,575,576,577,578,101,308,579,27,580,581,582,583,584,585,586,587,588,589],"Diabetes (DM)","Diabete Mellitus","Diabete Type 1","Diabete Type 2","Diabetes Distress","Diabetes Complications","Depression Bipolar","Anxiety Disorder (Panic Disorder or GAD)","Anxiety Disorder NOS","Eating Disorder Binge","Anorexia Nervosa","Bulimia Nervosa","Eating Disorder Not Otherwise Specified","Depressed Mood","Anxiety Symptoms","Disordered Eating Behaviors","Fear of Hypoglycemia",[591,592,593,594,595,596,597,598,599,600,601,602,103,168,603,577,567],"Digital Twin","Precision Medicine","Precision Mental Health","Subclassification","Trajectories","Subtypes","Person-reported Outcomes (PRO)","Ecological Momentary Assessment (EMA)","Continuous Glucose Monitoring (CGM)","People with Diabetes (PWD)","Diabetes Mellitus","HbA1c","Eating disorder","2025-11-27",{"date":606,"type":48},"2025-12-04",{"date":608,"type":48},"2025-01-01",{"date":610,"type":21},"2027-12-31",{"name":612,"class":55},"Forschungsinstitut der Diabetes Akademie Mergentheim",3,{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":620,"targetDuration":4,"studyType":67,"phases":622,"briefSummary":623,"conditions":624,"keywords":626,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":56},"100599323","comparing-the-efficacy-of-heated-yoga-and-sauna-as-a-treatment-for-depression-100599323","NCT07082998","Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression","Subject Characteristics\n\nInclusion Criteria:\n\n1. adults (18-65 years old)\n2. Ability to provide informed consent\n3. English language proficiency\n4. PHQ-9 score \\> 10, indicating at least moderate depressive symptoms 21\n5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\\*\n6. Individuals of childbearing potential must use an acceptable form of birth control\n7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study\n8. Must be able to access mindfulness app on a device (i.e., smartphone, iPad, etc.)\n9. Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant\n2. Breast feeding\n3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)\n4. Active eating disorders or substance use disorders within the past 12 months, as per the MINI\n5. Primary OCD or PTSD, as per the MINI\n6. History of bipolar disorder, psychotic disorders, as per the MINI\n7. ≥25% drop in PHQ-9 score from screen to baseline\n8. Under the influence or withdrawal of drugs or alcohol\n9. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the PI or designee)\n10. have had a bone fracture or joint surgery in the past 6 months\n11. not able to walk freely or without difficulty\n12. any serious, unstable medical condition as determined by the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)\n13. participants must have a healthcare provider who they could contact if they needed medical care, such as a primary care doctor, a counselor, a psychiatrist, a nurse practitioner, or a clinic that you go to.\n14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)\n15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)\n16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)\n17. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent) diuretics, barbiturates, b-blockers, anticholinergics, current ETOH acute intoxication, reduced ability to sweat, hemophilia, pacemaker (magnets used to assemble saunas can interrupt the pacer)\n18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit\n19. psychotherapy that has been initiated within the past 3 months\n20. psychiatric hospitalization within the past year\n21. diagnosed with any neurological disorders that would impact participation or make participation unsafe\n22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments\n23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)\n24. A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity",{"count":621,"type":21},120,[69],"This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms",[27,101,102,625,103,100],"Depression Chronic",[37,627,628,629,630,631,632],"heated yoga","yoga","sauna","mindfulness","mindfulness app","clinical trial","2025-11-11",{"date":635,"type":48},"2025-11-13",{"date":637,"type":48},"2025-09-12",{"date":639,"type":21},"2027-07-31",{"name":641,"class":55},"Massachusetts General Hospital",{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":525,"acronym":647,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":648,"targetDuration":4,"studyType":67,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":56},"100587100","expansion-and-evaluation-of-ai-generated-clinical-assessment-ai-coa-of-depression-and-anxiety-severity-100587100","NCT06923995","Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity","SEQUOIA-1",{"count":621,"type":21},[69],"The SEQUOIA-1 study evaluates the effectiveness of Artificial Intelligence (AI) in measuring depression and anxiety severity in adults. Investigators from Deliberate Solutions, Inc. and Baylor College of Medicine are conducting this study to determine whether AI can provide reliable clinical assessments of mood and anxiety disorders.\n\nIn clinical trials for new depression and anxiety treatments, human clinicians typically conduct interviews to evaluate participants' symptoms. These assessments are critical but may vary based on the clinician's experience or interview style, potentially affecting the reliability of research findings.\n\nTo address this challenge, the study team developed an AI-based Clinical Outcome Assessment tool, called AICOA®, which analyzes video interviews to measure symptoms of depression and anxiety consistently and objectively. AI-COA® has been accepted by the U.S. Food and Drug Administration (FDA) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program.\n\nThe primary objectives of the SEQUOIA-1 study are to collect additional data to improve model accuracy and to evaluate model performance across diverse demographic groups. The study also pilots the use of an AI interviewer-an interactive digital agent-to conduct remote assessments.\n\nDuring the study, participants will complete questionnaires about their symptoms and perform brief tasks. Participants will also provide feedback regarding their experience interacting with the AI interviewer.\n\nAll assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians.\n\nThe development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.",[27,220],{"date":635,"type":48},{"date":654,"type":48},"2025-09-01",{"date":656,"type":21},"2026-02-28",{"name":543,"class":120},{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":64,"sex":16,"minAge":193,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":67,"phases":667,"briefSummary":668,"conditions":669,"keywords":672,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":693,"locationsCount":56},"100601239","evaluating-and-implementing-the-connect-program---a-group-based-telehealth-intervention-to-reduce-social-isolation-loneliness-and-mental-health-symptoms-in-adults-ages-55-compared-to-routine-community-based-programming-100601239","NCT07107906","Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming","The CONNECT Program: Engaging Community Organizations in the Implementation and Evaluation of a Group Telehealth Mental Health Program for Older Canadians","Inclusion Criteria:\n\n* Adults aged 55 years or older\n* Able to speak, read, and understand English\n* Can manage hearing or vision changes well enough to participate in group conversations\n* Self-reported experiences of loneliness, social isolation, and\u002For mental health challenges (e.g., anxiety or depressive symptoms)\n\nExclusion Criteria:\n\n* Cannot communicate in English (verbal or written)",{"count":666,"type":21},128,[69],"Older adults in Canada are experiencing increasing levels of social isolation, loneliness, and mental health challenges, including anxiety and depression - trends that have worsened during and following the COVID-19 pandemic. Research consistently shows that loneliness and social isolation are associated with poorer mental and physical health outcomes, increased risk of dementia, and increased mortality. At the same time, social connection has a strong protective impact on health and well-being. Community-based programs that promote both social engagement and psychological support are urgently needed, particularly since older adults are less likely to access formal mental health services.\n\nApproximately 3-11% of older adults meet diagnostic criteria for mood or anxiety disorders each year, with even more experiencing elevated symptoms that greatly influence quality of life. Subsyndromal depression in late life is estimated to occur two to three times more often than major depressive disorder. Despite these needs, up to 70% of older adults with anxiety or mood disorders do not access psychological services, often due to low mental health literacy or practical barriers to care. At the same time, participation in community activities is associated with improved emotional well-being, greater social support, and lower rates of depression and anxiety.\n\nTo bridge this need for support, our team developed and pilot-tested The CONNECT Program - a group-based mental health intervention for adults 55 years and older, delivered via telephone or virtually. The CONNECT Program is grounded in Acceptance and Commitment Therapy (ACT), self-compassion, and theories of successful aging, and aims to improve psychological flexibility; reduce loneliness, social isolation, and co-occurring symptoms of depression and anxiety. A Manitoba pilot study (N = 34) demonstrated promising outcomes in terms of feasibility, acceptability, and preliminary effectiveness with the telephone-based group intervention.\n\nThe current trial will evaluate the implementation and effectiveness of The CONNECT Program in four Canadian provinces (British Columbia, Manitoba, New Brunswick, Saskatchewan), using an implementation-effectiveness hybrid design and a crossover randomized controlled trial. This study compares The CONNECT Program, delivered via telephone or virtually, to routine community programming (i.e., community participation as usual), which may occur in telephone, virtual, or in-person formats. The primary outcome is psychological flexibility; secondary outcomes include loneliness, social isolation, anxiety, depression, emotional support, mental health literacy. Implementation outcomes will be evaluated following the Proctor et al. framework.\n\nThis trial will contribute evidence on the mental health needs of adults 55+ and the value of low-barrier, community-based programs delivered remotely. Findings will guide further national and international implementation of The CONNECT Program and similar initiatives aimed at addressing the challenges of loneliness, social isolation, and mental health problems in late life.",[670,671,27,168],"Loneliness","Social Isolation",[673,670,671,168,103,674,675,676,677,678,679,680,681,682,683,684,685,686],"Psychological Flexibility","Older adult","Aged","Psychotherapy, Group","Acceptance and Commitment Therapy","Mental Health","Telemedicine","Mental Health Teletherapy","Community Mental Health Services","Community-Based Participatory Research","Program Evaluation","Randomized Controlled Trial","Implementation Effectiveness Hybrid Design","Cross-Over Studies","2025-09-17",{"date":689,"type":48},"2025-09-19",{"date":691,"type":48},"2025-09-08",{"date":52,"type":21},{"name":694,"class":55},"University of Manitoba",{"id":696,"slug":697,"hasResults":12,"nctId":698,"briefTitle":699,"officialTitle":699,"acronym":4,"eligibilityCriteria":700,"healthyVolunteers":12,"sex":16,"minAge":701,"maxAge":702,"enrollmentInfo":703,"targetDuration":4,"studyType":67,"phases":705,"briefSummary":706,"conditions":707,"keywords":709,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":712,"lastUpdatePostDateStruct":713,"startDateStruct":715,"completionDateStruct":717,"leadSponsor":719,"locationsCount":56},"100604700","the-impact-of-beta-band-transcranial-alternating-current-stimulation-tacs-on-impulse-inhibition-in-adolescents-with-non-suicidal-self-injury-100604700","NCT07152925","The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury","Inclusion Criteria:\n\n* 1\\) Meet the proposed diagnostic criteria for non-suicidal self-injury (NSSI) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with ≥5 documented self-injury episodes and at least one incident within the past month as assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ); 2) Aged 12-18 years; 3) Right-handed; 4) Possess formal education experience sufficient to comprehend experimental protocols; 5) Normal or corrected-to-normal binocular visual acuity; 6) Voluntarily participate with legal guardians providing written informed consent.\n\nExclusion Criteria:\n\n* 1\\) Montreal Cognitive Assessment (MoCA) score \\\u003C 26; 2) History of suicide attempt(s); 3) Medical history of epilepsy, brain surgery, intracranial tumors, metal implants in the skull, or clinically significant head trauma; 4) History of substance use disorder, brain injury, severe somatic diseases, psychiatric disorders, or comorbid DSM-5 psychiatric conditions; 5) Prior receipt of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or repetitive transcranial magnetic stimulation (rTMS) within the past 3 months","12 Years","22 Years",{"count":704,"type":21},60,[69],"This clinical trial aims to determine whether beta-band transcranial alternating current stimulation (tACS) can improve impulse inhibition in adolescents with non-suicidal self-injury (NSSI) and to evaluate its safety. The primary questions it seeks to answer are:\n\n* Can beta-band tACS significantly reduce the frequency of self-injury and scores on impulsivity scales in adolescents with NSSI?\n* What discomfort or medical issues may participants experience during tACS intervention?\n\nResearchers will compare beta-band tACS with sham stimulation (a procedure that mimics the real stimulation without delivering effective current) to verify its efficacy.\n\nParticipants will:\n\n* Receive two sessions of either tACS or sham stimulation daily, spaced 4 hours apart, for 7 consecutive days (14 sessions in total).\n* Undergo scale assessments, behavioral tasks, and eye-tracking tests before and after the intervention.\n* Record any self-injury episodes and adverse reactions, with continuous monitoring and psychological support provided by a professional team.",[27,708],"Non-suicidal Self-injury",[103,710,711],"non-suicidal self-injury","transcranial alternating current stimulation","2025-08-26",{"date":714,"type":48},"2025-09-03",{"date":716,"type":48},"2025-03-01",{"date":718,"type":21},"2026-05-31",{"name":720,"class":55},"Anhui Medical University"]