[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anxiety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anxiety":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,612,0,25,[9,50,84,106,134,163,188,212,241,266,293,320,343,369,397,424,452,472,498,527,546,576,607,636,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053368","effect-of-patient-anxiety-level-prior-to-undergoing-ercp-and-procedure-tolerability-and-outcomes-100053368",false,"NCT07699731","Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.","The Effect of Pre-procedural Anxiety Level on Procedure Tolerability and Quality of ERCP in Consciously Sedated Patients","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Undergoing ERCP for any indication with conscious sedation\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability or refusal to provide informed consent\n* Cognitive impairment or language barriers precluding questionnaire completion\n* Emergent ERCP where pre-procedural questionnaire administration is not feasible","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Endoscopic Retrograde Cholangiopancreatography (ERCP) is a specialized procedure combining upper GI endoscopy and x-rays to treat hepatopancreaticobiliary diseases. Patient experiences after ERCP has been relatively understudied.\n\nThe goal of this prospective observational study is to understand how anxiety before ERCP affects patient experience and tolerance of the procedure.\n\nThis study includes adults (18 years and older) undergoing ERCP with conscious sedation at Kingston Health Sciences Centre. Researchers will measure pre-procedure anxiety and examine how it relates to patient comfort, cooperation during the procedure, and overall patient-reported experience.\n\nThe main questions are whether higher pre-procedure anxiety is associated with lower procedure tolerability and reduced cooperation during ERCP.\n\nParticipants will:\n\n1. Complete a short anxiety questionnaire before the procedure\n2. Undergo ERCP with standard sedation as planned by their care team\n3. Complete a post-procedure questionnaire about comfort, pain, and other symptoms\n4. Have procedure details and outcomes recorded from medical records\n\nEndoscopists will also complete a short survey to state any concerns prior to procedure as well as evaluate patient's cooperation during the procedure.\n\nPatient-reported experience will be compared with physician assessments of cooperation during the procedure.\n\nFindings may help recognize patients at higher risk of distress during ERCP and guide strategies to improve comfort, sedation planning, and overall procedure quality to lead to the best outcomes.",[25,26,27],"Anxiety","Biliary and Pancreatic Diseases","ERCP",[27,29,30,31,32,33,34,35,36],"Endoscopic retrograde cholangiopancreatography","Conscious sedation","Pre-procedural anxiety","Patient experience","STAI-Y","PRO-STEP","Upper endoscopy","Procedural sedation","NOT_YET_RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":21},"2026-08-01",{"date":45,"type":21},"2027-10-01",{"name":47,"class":48},"Mandip Rai","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":71,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":49},"100053713","facilitated-transitions-from-postpartum-to-primary-care-coordination-for-people-with-chronic-conditions-100053713","NCT06557005","Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions","Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions","Inclusion Criteria\n\n* Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)\n* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age\n* If postpartum, has a neonate that is currently living at the time of enrollment\n* Has one or more of the following conditions listed in the \"Problem List,\" \"Medical History,\" or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):\n\n  * Chronic or essential hypertension\n  * Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)\n  * Type 1 or 2 diabetes (i.e., pre-existing diabetes)\n  * Gestational diabetes\n  * Class II Obesity (pre-pregnancy body mass index ≥35 kg\u002Fm2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg\u002Fm2)\n  * Depression or anxiety disorder\n* Has a primary care clinician listed in the patient's medical record\n* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities\n* Able to read\u002Fspeak English or Spanish language\n* Is age ≥18 years old\n\nExclusion Criteria\n\n• Any individual not meeting all inclusion criteria","FEMALE",{"count":59,"type":21},1320,"INTERVENTIONAL",[62],"NA","The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \\>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.",[65,66,67,68,25,69,70],"Hypertension","Diabetes","Postpartum","Pregnancy","Depression","Obesity",[72,73,74,75],"Postpartum Care","Primary Care","Care Transitions","Chronic Disease","RECRUITING",{"date":40,"type":41},{"date":79,"type":41},"2025-05-23",{"date":81,"type":21},"2028-05-23",{"name":83,"class":48},"Massachusetts General Hospital",{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":17,"minAge":90,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":60,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":49},"100610175","developing-a-digital-intervention-for-adolescent-nonsuicidal-self-injury-100610175","NCT07224165","Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury","Inclusion Criteria:\n\n* Current NSSI (NSSI on 2 or more days in the last month\n* English language skills sufficient to engage in the consent and intervention procedures\n* Age 14-18\n* Access to smartphone\n\nExclusion Criteria:\n\n* Severe mental health diagnoses for which this intervention would be inappropriate (psychotic disorders, active manic episodes)\n* Severe suicide risk, including suicidal ideation with a plan and intent to act\n* Current engagement in psychotherapy","14 Years",{"count":92,"type":21},80,[62],"This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.",[96,69,25],"Nonsuicidal Self-injury","2026-07-01",{"date":99,"type":41},"2026-07-02",{"date":101,"type":41},"2026-06-04",{"date":103,"type":21},"2027-07-31",{"name":105,"class":48},"Northwestern University",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":60,"phases":114,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":49},"100641300","effects-of-vr-on-preanesthetic-anxiety-100641300","NCT07656246","Effects of VR on Preanesthetic Anxiety","Effects of Virtual Reality Intervention on Anxiety and Uncertainty Before General Anesthesia Among Patients Undergoing Laparoscopic Cholecystectomy","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Able to communicate in Mandarin Chinese or Taiwanese and complete questionnaires.\n* ASA Physical Status I-II.\n* Hospitalized one day before surgery.\n* No previous experience with general anesthesia.\n* Scheduled for laparoscopic cholecystectomy under general anesthesia with endotracheal intubation.\n\nExclusion Criteria:\n\n* Psychiatric disorders.\n* Emergency surgery.\n* Visual or hearing impairment.",{"count":20,"type":21},[62],"In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery. However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia. This is mainly due to unfamiliarity with the anesthesia process, concerns about potential risks, and uncertainty regarding the overall experience. Excessive anxiety and uncertainty can not only affect the patient's emotional stability and cooperation but may also prolong postoperative recovery time and negatively impact the overall quality of medical care. Virtual Reality (VR) is an emerging innovative technology characterized by its immersive, interactive, and highly realistic features. It has been widely applied in fields such as education, psychotherapy, and healthcare education. By simulating the surgical environment and anesthesia process through VR technology, patients can gain visual and psychological adaptation before undergoing anesthesia. This helps enhance their understanding and sense of control over the medical procedure, thereby reducing feelings of unease and anxiety. The purpose of this study is to explore the effects of a virtual reality (VR) intervention on preoperative anxiety and uncertainty in patients undergoing laparoscopic cholecystectomy under general anesthesia. This experimental study recruited a total of 142 patients scheduled for surgery at a medical center, who were randomly assigned to either the experimental group or the control group. Patients in the experimental group, in addition to receiving standard printed preoperative education materials, experienced a VR video the day before surgery. The video introduced the operating room environment and anesthesia procedures. The control group received only the printed educational materials. Research instruments included measures of anxiety (Amsterdam Preoperative Anxiety and Information Scale \\[APAIS\\], Anxiety Visual Analogue Scale \\[VAS\\]), uncertainty (Uncertainty Visual Analogue Scale, Intolerance of Uncertainty Scale), and neuro-autonomic feedback indicators. Assessments were conducted before and after the intervention to evaluate its effectiveness. This study anticipates that the virtual reality (VR) intervention will effectively reduce patients' pre-anesthesia anxiety and uncertainty, thereby enhancing their adaptation to the general anesthesia process and improving psychological stability. The findings may provide clinical anesthesia nursing staff with evidence-based support for incorporating emerging technologies into pre-anesthesia education. Furthermore, the results can serve as a reference for developing diversified patient education models in the future.",[117,25,118,119],"Cholecystectomy, Laparoscopic","Uncertainty","Perioperative Period",[121,122,123,124,125],"Virtual Reality (VR)","Preoperative Anxiety","General Anesthesia","Patient Education","Physiological Feedback","2026-06-30",{"date":99,"type":41},{"date":129,"type":21},"2026-06-09",{"date":131,"type":21},"2028-12-31",{"name":133,"class":48},"Mackay Memorial Hospital",{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":60,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100603744","reduction-of-anxiety-in-people-with-disabilities-through-dual-treatment-digital-cbt--nbhwc-coaching---a-randomized-clinical-trial-100603744","NCT07140497","Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial","Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (RADD)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Presence of self-reported hearing or mobility disability\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Males and females; Age 22 years and above\n* Score of 15 or higher on the HAM-A\n* Clinical diagnosis of anxiety based on DSM-5 diagnostic criteria\n* Willingness to adhere to the Toivoa-001 or sham regimen once per week, including scheduling and weekly meetings with coaches\n* Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)\n* Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)\n* Able to read and speak English fluently\n* Resident of the United States and living in the United States for the duration of the trial\n\nExclusion Criteria:\n\n* Medical diagnosis of psychotic disorder or bipolar disorder\n* Participation in another treatment trial at the time of study\n* Substance use disorder in the past 12 months (excluding tobacco)\n* Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations)\n* Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period","22 Years",{"count":20,"type":21},[62],"The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-001, which combines digital cognitive behavioral therapy (CBT) with personal mental health coaching, can effectively reduce anxiety in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering anxiety symptoms over an 8-week period than a \"sham\" digital program that is developed to look similar but does not contain active therapeutic content.\n\nThe investigators hypothesize that participants who use the Toivoa-001 program will show significantly greater reductions in anxiety compared to those using the sham program, and that these mental health benefits will last through a 12-week follow-up.\n\nAdults within the disability community frequently encounter unique environmental and societal barriers - such as limited physical accessibility, transportation challenges, and workplace inflexibility - that can directly drive or worsen anxiety. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective anxiety relief tailored to the lived experiences of people with disabilities.",[146,25,147],"Hearing Disability","Mobility Disability",[25,69,149,150,151,152,153],"People with Hearing or Mobility Disability","Accessible Health for People with Disabilities and Veterans","Cognitive Behavioral Therapy","Cognitive Behavioral Therapy with Coaches","Coaches",{"date":99,"type":41},{"date":156,"type":21},"2026-08",{"date":158,"type":21},"2027-03",{"name":160,"class":161},"Toivoa Inc","INDUSTRY",4,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":60,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":162},"100528589","type-i-hybrid-effectiveness-implementation-trial-of-primary-care-brief-mindfulness-training-for-veterans-100528589","NCT06162741","Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans","Inclusion Criteria:\n\nTo be eligible, participants must be:\n\n* enrolled in VA primary care through the local VA site\n* report clinically significant psychological distress as measured in at least one of three areas:\n\n  * PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor\n  * depression operationalized as 10 on the PHQ-9\n  * anxiety operationalized by 10 on the GAD-7\n\nExclusion Criteria:\n\nExclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:\n\n* gross cognitive impairment\n* suicide attempt or desire to commit suicide in the last month\n\nTo allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:\n\n* had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled\n* had a change in psychiatric medication outside of VHA primary care in the last 2 months\n* voice a preference to be directly referred to specialty mental health care\n\nVeterans with mild TBI, and alcohol\u002F substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.",{"count":170,"type":21},300,[62],"The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and\u002For PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and\u002For PTSD and increase overall functioning.",[174,69,25],"Post Traumatic Stress Disorder (PTSD)",[176,174,177,73,178,69,25,179],"Psychological Distress","Mindfulness","Brief Intervention","Problem-solving training",{"date":99,"type":41},{"date":182,"type":41},"2024-08-19",{"date":184,"type":21},"2027-12-31",{"name":186,"class":187},"VA Office of Research and Development","FED",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":60,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100645160","effect-of-a-preoperative-educational-video-on-anxiety-levels-100645160","NCT07679659","Effect of a Preoperative Educational Video on Anxiety Levels","Effect of QR Code-Based and Tablet-Based Preoperative Educational Video Interventions on Preoperative Anxiety","PEVA","Inclusion Criteria:\n\n* Age 18 years or older.\n* Scheduled for elective surgery under anesthesia.\n* Able to understand Turkish.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Visual or hearing impairment preventing video viewing.\n* Cognitive impairment.\n* Neurological or psychiatric disorders that may interfere with communication or completion of study questionnaires.",{"count":197,"type":21},360,[62],"Preoperative anxiety is common among patients undergoing elective surgery and may negatively affect perioperative outcomes. This randomized controlled trial aims to evaluate the effectiveness of a short educational video in reducing preoperative anxiety. Participants will be assigned to one of three groups: a QR code-based video group, a tablet-based video group, or a control group receiving standard preoperative information. Anxiety levels will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The secondary objective is to evaluate the utilization of QR code-based video education.",[201,25],"Perioperative Anesthetic",[203,122,124,204],"Educational Video","QR Code","2026-06-29",{"date":97,"type":41},{"date":97,"type":21},{"date":209,"type":21},"2026-12-01",{"name":211,"class":48},"Aksaray University Training and Research Hospital",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":220,"sex":17,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":60,"phases":225,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":49},"100630118","bonding-before-birth-a-mhealth-intervention-for-first-time-expectant-couples-100630118","NCT07483515","Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples","Bonding Before Birth: A Cluster-randomized, Controlled, mHealth Trial for Developing Mindfulness and Emotional Regulation in Expectant Couples","B³","Inclusion Criteria:\n\nMothers:\n\n1. 21-50 years of age\n2. Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment\n3. Singleton pregnancy\n4. Nulliparous\n5. Plan to deliver in Singapore\n6. Proficient and able to respond to questionnaires in English\n7. Intends for herself and her child to stay in Singapore for the next 2 years\n8. Access to a smartphone\n9. Willing to download the study app\n10. Score of 7 or more in the Edinburgh Postnatal Depression Scale\n\nFathers:\n\n1. 21-75 years of age\n2. Proficient and able to respond to questionnaires in English\n3. Intends for himself and his child to stay in Singapore for the next 2 years\n4. Access to a smartphone\n5. Willing to download the study app\n\nExclusion Criteria:\n\nMothers:\n\n1. Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders\n2. Currently on oral\u002FIV steroids and\u002For thyroid medication\n3. History of thyroid disease\n4. Pregnant using assisted reproductive technologies\n5. Multiple pregnancies\n6. Currently enrolled in interventional randomised controlled trials\n7. Responded \"Yes, quite often\" to EPDS item 10 (\"The thought of harming myself has occurred to me\")\n\nFathers:\n\n1\\. Currently enrolled in interventional randomised controlled trials",true,"21 Years","75 Years",{"count":224,"type":21},572,[62],"Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers\u002Fpartners playing a significant role in influencing maternal stress and mood symptoms.\n\nThis goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.\n\nExpecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.\n\nParticipants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.",[25,68,228,229,69,230],"Parenting Self-efficacy","Stress (Psychology)","Emotion Regulation",[232,233,230,69,68,25],"Reinforcement Learning","Micro-randomization","2026-06-28",{"date":126,"type":41},{"date":237,"type":21},"2026-07-06",{"date":131,"type":21},{"name":240,"class":48},"Institute for Human Development and Potential (IHDP), Singapore",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":90,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":251,"conditions":252,"keywords":255,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":49},"100564767","adolescent-psychiatry-inpatients-self-reported-parent-adolescent-communication-quality-and-treatment-outcome-100564767","NCT06633458","Adolescent Psychiatry Inpatients: Self-reported Parent-adolescent Communication Quality and Treatment Outcome","Adolescent Psychiatry Inpatients: Self-reported Parent-adolescent Communication Quality as a Predictor of Treatment Outcome","Inclusion Criteria:\n\n* Admission to inpatient care unit of the adolescent psychiatry at the University Medical Center Hamburg-Eppendorf.\n\nExclusion Criteria:\n\n* Severe symptom burden at admission\n* Lack of knowledge of the German language.","17 Years",{"count":250,"type":21},60,"The quality of parent-adolescent communication has been found to be associated with adolescent mental health. However, little is known about the association of parent-adolescent communication and adolescent mental health in the context of psychiatry inpatient treatment.\n\nThis study aims to find out whether self-reported parent-adolescent communication quality at the time of admission to psychiatry predicts the treatment outcome in terms of symptom reduction 6 months later in an adolescent inpatient sample. It also aims to track changes in adolescent self-reported communication quality in the course of inpatient treatment and afterwards (2, 4 and 6 months after admission) to see whether improvement predicts treatment outcome, with treatment outcome being defined as symptom reduction to baseline. As a secondary endpoint, it will be assessed whether a placement of the adolescent outside the family was considered during treatment and whether self-reported communication quality at the time of admission predicts the consideration of placement outside the family.",[253,254,25],"Mental Disorder in Adolescence","Depression in Adolescence",[256,257,258],"mental health","adolescence","communication",{"date":97,"type":41},{"date":261,"type":41},"2024-07-08",{"date":263,"type":21},"2027-10-30",{"name":265,"class":48},"Universitätsklinikum Hamburg-Eppendorf",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":60,"phases":276,"briefSummary":277,"conditions":278,"keywords":285,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":290,"leadSponsor":291,"locationsCount":49},"100645034","effect-of-virtual-reality-guided-imagery-on-pain-anxiety-and-fatigue-in-cancer-patients-undergoing-chemotherapy-100645034","NCT07677436","Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy","Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial","VRGI-Chemo Tri","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n* Histologically confirmed breast cancer.\n* Stage I, II, or III breast cancer.\n* Underwent surgery as the initial treatment and are scheduled to receive the first cycle of adjuvant chemotherapy, with or without biologic therapy (e.g., AC or TC regimens).\n* Able to read, write, and communicate.\n* Able and willing to use a virtual reality headset.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Visual or hearing impairment that prevents the use of virtual reality.\n* Serious neurological or psychiatric disorders.\n* Current participation in other non-pharmacological interventions (e.g., meditation or relaxation therapy) that could influence the study outcomes.\n* Previous experience with virtual reality-guided imagery.\n* Use of analgesics, anxiolytics, or other medications during the intervention that may affect the study outcomes.",{"count":275,"type":21},108,[62],"This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care",[279,280,281,282,283,25,284],"Virtual Reality","Guided Imagery","Breast Cancer","Chemotherapy","Pain","Fatigue",[286],"Virtual Reality, Guided Imagery , Breast Cancer, Chemotherapy , Pain, Anxiety , Fatigue","2026-06-27",{"date":126,"type":41},{"date":97,"type":21},{"date":158,"type":21},{"name":292,"class":48},"Thoalfokar Mohammed Al-Obaidi",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":60,"phases":302,"briefSummary":303,"conditions":304,"keywords":307,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":49},"100642930","mobile-cognitive-behavioral-therapy-in-early-stroke-recovery-100642930","NCT07639606","Mobile Cognitive Behavioral Therapy in Early Stroke Recovery","Inclusion Criteria:\n\n* Age 18-79\n* Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score \\>= 8) and\u002For HADS-A (anxiety, score \\>= 8).\n* Stroke that occurred within 1 month prior to study initiation.\n* Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC)\n* Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties\n* Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team)\n* Able to adhere to all study requirements and willingness to participate in the full study duration\n\nExclusion Criteria:\n\n* Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care\n* Non-fluency in English\n* History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review)\n* Active suicidal ideation requiring a higher level of care\n* Severe depression and\u002For anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and\u002For immediate referral to psychiatric services\n* Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant","79 Years",{"count":301,"type":21},10,[62],"This study aims to pilot \"Maya,\" a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and\u002For anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.",[25,305,306],"Stroke","Depression - Major Depressive Disorder",[308,309,310,311],"stroke recovery","stroke rehabilitation","cognitive behavioral therapy","CBT","2026-06-26",{"date":126,"type":41},{"date":315,"type":21},"2026-07",{"date":317,"type":21},"2029-03",{"name":319,"class":48},"Weill Medical College of Cornell University",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":327,"maxAge":18,"enrollmentInfo":328,"targetDuration":4,"studyType":60,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":4},"100645307","evaluating-virtual-reality-use-in-anxiety-management-in-adolescents-100645307","NCT07681206","Evaluating Virtual Reality Use in Anxiety Management in Adolescents","Evaluating the Potential of Virtual Reality Intervention in Anxiety Management Among Adolescent Patients: An Interventional Study","Inclusion criteria:\n\n* Adolescents aged 12-18 receiving care at the outpatient clinics of study locations\n* Patients with a GAD-7 score more than 5\n\nExclusion criteria:\n\n* Patients younger than 12 years old or older than 19 years old\n* Patients with a GAD-7 score lower than 5\n* Patient of legal age but subject to legal protection measures or unable to express their consent\n* Patients with dissociative psychiatric disorders\n* Patients suffering from uncontrolled epilepsy\n* Patients with visual or auditory disorders\n* Patients suffering from claustrophobia or motion sickness\n* Patients with face infections","12 Years",{"count":329,"type":21},50,[62],"This study examines the effectiveness of virtual reality (VR) protocols based on mindfulness as a nonpharmacological approach to reduce social anxiety among adolescents. Conducted as a non-randomized, controlled, multi-center trial, the research aims to provide evidence supporting the integration of VR mindfulness interventions into clinical practice to improve mental health and well-being among adolescents. The research focuses on adolescent patients aged 12 to 18 who present with anxiety-related symptoms. Each participant will undergo a single primary care consultation, during which they will experience a 15-20 minute VR session using the Healthy Mind® platform both before and after their clinical encounter. Participants will be screened with the Generalized Anxiety Disorder 7 (GAD-7) scale. To measure changes in anxiety levels, the State-Trait Anxiety Inventory (STAI) will be administered immediately before and after the VR sessions. This setup aims to assess the immediate impact of immersive VR on perceived anxiety in a real-world outpatient environment.",[25],[334,335],"Immersive virtual reality","Anxiety in adolescents",{"date":99,"type":41},{"date":338,"type":21},"2026-06-23",{"date":340,"type":21},"2026-10",{"name":342,"class":48},"Mohammed Bin Rashid University of Medicine and Health Sciences",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":349,"maxAge":90,"enrollmentInfo":350,"targetDuration":4,"studyType":60,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100604914","phase-ii-engagement-and-clinical-impact-of-the-teleo-virtual-therapy-platform-in-clinical-settings-100604914","NCT07155707","Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings","Inclusion Criteria:\n\n* Diagnosed with a mood and\u002For anxiety disorder\n* Have proficiency to participate in psychotherapy in English\n* Scheduled to begin therapy at one of the study sites\n* RCADS score \\> 65\n\nExclusion Criteria:\n\n\\- Comorbid diagnosis of intellectual disability, autism spectrum disorder, psychotic disorders, high-risk suicidal behaviors requiring immediate hospitalization, substance use disorders, or other physical or mental condition that would prohibit them from engaging in telehealth settings.","5 Years",{"count":351,"type":21},156,[62],"This Phase II trial will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the trial will examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.",[25,355],"Mood Disorders",[357,358,25,69,359,360],"Teletherapy","Therapeutic Engagement","Youth Mental Health","Digital Mental Health",{"date":205,"type":41},{"date":363,"type":41},"2026-06-24",{"date":365,"type":21},"2027-09-15",{"name":367,"class":48},"Stanford University",2,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":60,"phases":379,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":49},"100644565","effects-of-an-osteopathic-manual-therapy-protocol-on-heart-rate-variability-stress-and-anxiety-in-young-adults-100644565","NCT07670806","Effects of an Osteopathic Manual Therapy Protocol on Heart Rate Variability, Stress, and Anxiety in Young Adults","Effect of an Osteopathic Intervention Protocol on the Parasympathetic System on Stress and Anxiety in Young Adults: a Randomized Clinical Trial","Inclusion Criteria:\n\n* age between 18 and 35 years old;\n* presence of symptoms\u002Fdiagnosis of stress and\u002For anxiety in the last week.\n\nExclusion Criteria:\n\n* individuals with cognitive impairments that prevent participation;\n* individuals with cardiovascular problems;\n* pregnant women;\n* those taking medications that affect cardiac function, anxiolytics, and antidepressants;\n* caffeine consumption in the last 4 hours;\n* alcohol consumption in the previous 24 hours;\n* tobacco use in the last 48 hours;\n* recent cervical trauma;\n* students of osteopathy.","30 Years",{"count":378,"type":21},30,[62],"Anxiety is characterized by excessive worry and anticipation of future threats, often accompanied by physiological and behavioral manifestations. Anxiety disorders are among the most prevalent mental health conditions worldwide and represent a significant public health concern, particularly among young adults and university students, who frequently experience academic, social, and financial stressors. The aim of this randomized clinical trial is to evaluate the effect of a protocol, consisting of 4 manual techniques, compared to a placebo group, in heart rate variability immediately after the intervention and in anxiety after one week in young adults. The main questions it aims to answer are:\n\nDoes the osteopathic intervention protocol influence the parasympathetic nervous system? Does the osteopathic intervention protocol influence anxiety and stress?\n\nThe researchers will compare the osteopathic protocol to a placebo (simulation technique), in order to see if the protocol influences anxiety and stress. Participants will:\n\nPrior to the intervention, complete the EADS questionnaire and undergo measurement of heart rate variability; Undergo the protocol or placebo; Immediately after the intervention, they will undergo the measurement of heart rate variability; After one week in the intervention, complete the questionnaire EADS.",[382,25],"Stress",[25,384,385,386,387,388],"Autonomic System Nervous","Parasympathetic Autonomic System Nervous","heart rate variability","Manual Therapy Techniques","Young Adults","2026-06-25",{"date":205,"type":41},{"date":392,"type":21},"2026-06",{"date":394,"type":21},"2026-09",{"name":396,"class":48},"Escola Superior de Tecnologia da Saúde do Porto",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":60,"phases":406,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":49},"100644014","a-study-of-the-impact-of-a-virtual-reality-medical-device-hypnovr-headset-on-anxiety-and-pain-in-interventional-radiology-100644014","NCT07668050","A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology.","HYPNO-VR","Inclusion Criteria :\n\n* Age ≥18 years.\n* Scheduled to undergo an interventional radiology procedure performed under local anesthesia without sedation.\n* Affiliation to a health insurance system.\n* Received complete information about the study and provided written informed consent.\n* Ability to understand the study information and complete the questionnaires.\n\nExclusion Criteria :\n\n* Refusal to participate or withdrawal of consent.\n* Patients under legal protection preventing valid informed consent according to regulatory requirements.\n* Inability to understand study-related information or to use the virtual reality device due to severe visual, auditory, or cognitive impairment, as clinically assessed by the investigator.\n* History of photosensitive epilepsy or uncontrolled epilepsy, constituting a contraindication to virtual reality use.\n* Known contraindication to virtual reality use (history of severe cybersickness).",{"count":405,"type":21},70,[62],"Patients undergoing interventional radiology procedures frequently experience significant anxiety and procedural pain despite standard care. Virtual reality (VR) has emerged as a promising non-pharmacological tool for anxiety and pain reduction in various medical settings.\n\nThe HYPNO-VR study is a prospective randomized controlled trial designed to evaluate the effect of immersive virtual reality during interventional radiology procedures. Participants will be randomized in a 1:1 ratio to either a virtual reality group or a standard care control group.\n\nThe primary objective is to assess the impact of VR on procedural anxiety and pain using validated anxiety questionnaires (State-Trait Anxiety Inventory, STAI) and a numerical pain rating scale.\n\nSecondary and exploratory objectives include assessment of patient satisfaction, operator experience, procedural duration, analgesic use, and feasibility of VR integration in interventional radiology practice.",[25,283,409],"Radiology, Interventional",[279,411,412,413,414,415,416,417],"Interventional Radiology","State-Trait Anxiety Inventory","Patient Satisfaction","Non-pharmacological Intervention","Immersive Virtual Reality","Procedural Anxiety","Procedural Pain",{"date":205,"type":41},{"date":392,"type":21},{"date":421,"type":21},"2026-12",{"name":423,"class":48},"University Hospital, Clermont-Ferrand",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":60,"phases":435,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":49},"100644684","flowmd-feasibility-study-100644684","NCT07672925","FlowMD Feasibility Study","Feasibility of Using a Meditation App in Adults With Anxiety Disorder","FLowMD","Inclusion Criteria:\n\n* Are 18-65 years old\n* Have an anxiety disorder\n* Have a smartphone\n* Able to download the FlowMD app\n* Willing to use the FlowMD meditation app for a daily 1-5 minute session for four consecutive weeks\n* Able to provide feedback on the experience using the app\n* Willing to participate in surveys to measure changes in anxiety levels\n\nExclusion Criteria:\n\n* Are undergoing significant changes in psychiatric medication or therapy\n* Have severe psychiatric conditions that might interfere with study participation (Schizophrenia, Bipolar Disorder, Major Depressive Disorder)","65 Years",{"count":434,"type":21},40,[62],"The goal of this clinical trial is to learn if the FlowMD mobile app is feasible to be used to manage mild anxiety in adults. It will also learn if the app is effective at managing anxiety in adults.\n\nParticipants will:\n\nUse the FlowMD app daily to complete a 1-5 minute guided breathwork session over the course of 4 weeks.\n\nComplete surveys at the beginning, midpoint, and end of the study to measure anxiety levels and usability of the app.",[25],[439,440,441,442,443],"anxiety","breathwork","meditation","feasibility","mobile app","2026-06-22",{"date":205,"type":41},{"date":447,"type":41},"2025-10-15",{"date":449,"type":21},"2026-12-31",{"name":451,"class":48},"National University of Natural Medicine",{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":60,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":49},"100644597","assessment-of-the-benefits-of-psychological-care-before-anterior-cruciate-ligament-surgery-of-the-knee-clipper-100644597","NCT07671430","Assessment of the Benefits of Psychological Care Before Anterior Cruciate Ligament Surgery of the Knee (CLIPPER)","CLIPPER","Inclusion Criteria:\n\n* Patient having signed the consent form for participation in the study\n* Patient scheduled for first-line outpatient ACL reconstruction surgery\n* Patient with a score \\>30 on the SFQ questionnaire (which assesses fear of surgery)\n* Patient with the ability to connect to the internet and follow a teleconsultation on a screen\n\nExclusion Criteria:\n\n* Surgical history of the operated knee\n* History of psychiatric disorders and\u002For regular use of psychotropic medication\n* Regular use of opioid medication\n* Mental disability or any other reason that may hinder understanding or strict adherence to the protocol\n* Patient not affiliated with the French social security system\n* Patient under legal protection, guardianship or curatorship\n* Pregnant, breastfeeding or childbearing women without effective contraception\n* A patient who is already enrolled in another therapeutic study protocol or who has participated in another trial within the past three months",{"count":460,"type":21},126,[62],"The primary objective of this study is to assess the impact of a preoperative psychological consultation on postoperative pain in anxious patients undergoing primary anterior cruciate ligament reconstruction surgery.",[25,464],"Ligament Reconstruction Surgery",{"date":312,"type":41},{"date":467,"type":41},"2026-05-07",{"date":469,"type":21},"2027-10",{"name":471,"class":48},"GCS Ramsay Santé pour l'Enseignement et la Recherche",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":60,"phases":481,"briefSummary":482,"conditions":483,"keywords":486,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":49},"100631623","pilot-study-of-sensor-informed-smartphone-based-mental-health-interventions-for-mood-in-early-psychosis-100631623","NCT07503093","Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis","Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis","Inclusion Criteria:\n\n* Age 18-50 years\n* History of DSM-5 psychotic disorder (e.g., schizophrenia, schizoaffective disorder, psychosis not otherwise specified)\n* Current elevated mood symptoms, defined as mild or greater depressive symptoms (Patient Health Questionnaire-8 score ≥5) or anxiety symptoms (Generalized Anxiety Disorder-7 score ≥5)\n* Own a personal iPhone or Android smartphone\n* Willing and able to provide informed consent\n* English-speaking\n\nExclusion Criteria:\n\n* Active suicidal ideation with both intent and a specific plan.\n* Current substance use disorder requiring acute treatment\n* Diagnosis of neurodevelopmental disorder that would impair ability to use smartphone app or complete study procedures\n* Traumatic brain injury with significant cognitive impairment","50 Years",{"count":301,"type":21},[62],"The aim of this trial is to evaluate the feasibility and preliminary efficacy of using passive smartphone sensors to detect moments of heightened negative mood and inform the timing of brief mental health interventions, such as mindfulness exercises and psychoeducation, in adults with early psychosis.",[484,25,69,485],"Psychosis","Rumination",[487,488,484,360,489,490,491],"Mirco-Randomized Study","Mobile Health","Negative Mood","Digital Phenotyping","Passive Sensors",{"date":389,"type":41},{"date":43,"type":21},{"date":495,"type":21},"2027-06-01",{"name":497,"class":48},"Mclean Hospital",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":60,"phases":507,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":49},"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":434,"type":21},[62],"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.",[510,511,25,512],"Suicidal Ideation","Suicide Attempt","Depression Disorders",[514,515,516,517,518,519],"Peer Support Specialist (PSS)","Recovery Community Organization (RCO)","Mental Health Recovery","Transitional Age Youth (TAY)","UT Southwestern Medical Center","Young Adult",{"date":389,"type":41},{"date":522,"type":41},"2025-04-01",{"date":524,"type":21},"2027-12-01",{"name":526,"class":48},"University of Texas Southwestern Medical Center",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":60,"phases":535,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":49},"100577649","phase-2-trips---treatment-to-improve-depression-andor-anxiety-using-psilocybin-assisted-psychotherapy-in-cancer-survivors-100577649","NCT06801041","TRIPS - Treatment to Improve Depression and\u002For Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors","Inclusion Criteria:\n\n1. Subjects must have solid or hematological malignancy that does not involve the brain.\n2. Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months\n3. Age ≥ 18 years.\n4. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder, Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnoses are determined by. an MD Anderson licensed healthcare provider with graduate-level profession training and clinical experience in psychotherapy, licensed to practice independently.\n5. Have an ECOG performance status of 0, 1, or 2.\n6. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n7. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n8. Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance.\n9. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Patient tested positive for a prescribed substance are eligible. Patient failing on the 2nd test (UDS) will be excluded.\n10. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications for a minimum of 2 weeks prior to study. Intermittent or PRN use of short-acting anxiolytics or and anti-nausea medications (e.g., ondansetron) may be permitted as defined below in exclusionary criteria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n11. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n12. Eligible subjects will have a third-party transportation by a licenses driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home\n13. Fluent in Englishria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n\nExclusion Criteria:\n\n1. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self injurious behavior\n2. History of bipolar disorder, psychosis (including a history of schizophrenia).\n3. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.\n4. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n5. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.\n6. Documentation of current malignancy that is being treated with palliative intent.\n7. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n8. Patients with brain metastases.\n9. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) Blood Pressure \\>blood pressure \\>180\u002F120mmHG, HR \\>110 bpm . Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and \"white coat hypertension.\"\n10. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n11. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm on imaging ii. Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a one-time febrile seizure in childhood iii. History of stroke in the past 3 years iv. Untreated cerebral aneurysm v. Dementia vi. Ongoing delirium in which subjects would not have the capacity to participate in the study.\n\n12 a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>22 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort) viii. efavirenz f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\ni. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\nii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\niii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\niv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.\n\ng. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin.\n\nh. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\ni. Have an allergy or intolerance to any of the materials contained in the drug product.\n\nj. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and\u002For existential distress (e.g., pharmacologic or psychotherapeutic interventions).\n\n13\\. Patients with non-fMRI compatible implants will be eligible but will not have fMRI.",{"count":534,"type":21},20,[536],"PHASE2","This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and\u002For anxiety.",[69,25,539],"Cancer",{"date":363,"type":41},{"date":79,"type":41},{"date":543,"type":21},"2029-03-31",{"name":545,"class":48},"M.D. Anderson Cancer Center",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":60,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":49},"100556552","stress-management-program-100556552","NCT06526585","Stress Management Program","Examining the Immediate and Training Effects of Regular Stress Reduction Practices on Psychophysiological Markers of Anxiety","Inclusion Criteria:\n\n* Age 18 or older\n* No contraindications to MRI imaging (like ferromagnetic metal in their body)\n\nExclusion Criteria:\n\n* Pregnant or planning to get pregnant during study participation.\n* Not able or willing to come to research location twice for MRI assessments",{"count":92,"type":21},[62],"This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.",[382,25],[382,558,559,560,561,562,25,563,564,565,566,567,568],"Breathwork","Cyclic Sighing","Box Breathing","Hypnosis","Mood","Physiology","Heart Rate Variability","Respiratory Rate","fMRI","Brain Activity","Sleep","2026-06-19",{"date":363,"type":41},{"date":572,"type":41},"2025-03-12",{"date":574,"type":21},"2026-08-30",{"name":367,"class":48},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":432,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":60,"phases":586,"briefSummary":587,"conditions":588,"keywords":593,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":49},"100498084","effectiveness-of-a-joint-general-practitioner-pharmacist-intervention-on-benzodiazepine-deprescribing-in-the-elderly-100498084","NCT05765656","Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly","Evaluation of the Effectiveness of a Joint General Practitioner-Pharmacist Intervention on the Implementation of Benzodiazepine Deprescribing in the Elderly (BESTOPH-MG Trial): Protocol for a Cluster-randomized Controlled Trial","BESTOPH-MG","Inclusion Criteria:\n\n* outpatients aged 65 and over\n* followed by the general practitioner and the pharmacist of the GP-PO pair\n* having a prescription for an anxiolytic or hypnotic BZDR prescribed at least 4 times in the past year\n* the last prescription being less than 3 months old\n* having been dispensed monthly during the last 3 months\n* affiliated to a social security scheme\n* and having given consent to participate in the research.\n\nExclusion Criteria:\n\n* patients living in an institution\n* participating in a clinical trial\n* with epilepsy\n* active depression\n* uncontrolled mental disorders\n* unable to participate in an interview or answer a questionnaire (demented, non-French speaking, illiterate, deaf, ...)\n* under guardianship\n* with a dystonic syndrome\n* and patients who are not sufficiently autonomous to carry out the steps inherent in the study",{"count":585,"type":21},400,[62],"Benzodiazepines or related drug (BZDR) are consumed for hypnotic or anxiolytic purposes in most cases. The consequences of BZDR are multiple with an increased risk of daytime sedation, balance disorders leading to falls and fractures, cognitive disorders, road accidents and dementia. Given their comorbidities, physiological changes, and multiple medications, the elderly are more at risk of suffering from BZDR adverse events.\n\nInterprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively. Morever, motivational interviews (MI) may reduce the extent of substance abuse compared to no intervention.",[73,589,590,591,25,592],"Health Plan Implementation","Benzodiazepine Dependence","Elderly","Deprescribing",[594,595,596,597,598,599],"Primary care","collaborative practice","health plan implementation","deprescribing","benzodiazepine","elderly",{"date":363,"type":41},{"date":602,"type":41},"2023-10-16",{"date":604,"type":21},"2027-02-16",{"name":606,"class":48},"Nantes University Hospital",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":432,"enrollmentInfo":614,"targetDuration":4,"studyType":60,"phases":616,"briefSummary":617,"conditions":618,"keywords":622,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":632,"leadSponsor":634,"locationsCount":49},"100644239","mobile-app-based-yoga-and-meditation-in-rheumatoid-arthritis-100644239","NCT07666594","Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis","Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.","Inclusion Criteria:\n\n* Adults aged between 18 and 65 years.\n* Diagnosed with Rheumatoid Arthritis (RA) by a rheumatologist.\n* Disease in a stable phase (remission or low disease activity).\n* Access to a smartphone or tablet and sufficient proficiency in using mobile applications.\n* Cognitive sufficiency to provide written and verbal informed consent in Turkish.\n\nExclusion Criteria:\n\n* Presence of acute RA flare-ups.\n* Severe psychiatric diagnoses (e.g., psychosis, bipolar disorder, or severe major depression).\n* Severe cognitive impairment or dementia.\n* Pregnancy.\n* Regular practice of meditation or mindfulness within the last 6 months.\n* Participation in any other stress management program within the last 3 months.\n* Receipt of mental health services within the last 6 months.",{"count":615,"type":21},102,[62],"The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA).\n\nThe main questions it aims to answer are:\n\nDoes an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical\u002Fpsychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs?\n\nResearchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention.\n\nParticipants in the experimental group will:\n\nUse a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period.\n\nComplete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.",[619,25,620,621],"Rheumatoid Arthritis (RA)","Depression Anxiety Disorder","Mobile Health Technology (mHealth)",[623,624,625,626,627,628],"Rheumatoid Arthritis","Yoga","Mobile Health (mHealth)","Meditation","Cost Analysis","Psychological Stress","2026-06-18",{"date":363,"type":41},{"date":392,"type":21},{"date":633,"type":21},"2027-06",{"name":635,"class":48},"Tugba Civi Karaaslan",{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":220,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":60,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":49},"100542369","improving-psychological-outcomes-for-acute-respiratory-failure-survivors-using-a-self-management-intervention-100542369","NCT06341972","Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention","SMARA","Inclusion Criteria:\n\n* ≥18 years old\n* English speaking and not aphasic\n* ARF with mechanical ventilation via endotracheal tube \\> 24 hours\n* Expected hospital stay of \\>7 days at time of eligibility\n* Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)\n* Not delirious (ie, negative Confusion Assessment Method -ICU score)\n* Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)\\*\\*\n\nExclusion Criteria:\n\n* Pre-existing cognitive impairment (AD-8 score ≥2)\n* History of major psychiatric illness (i.e., psychotic disorder, bi-polar disorder, suicide attempt in past 24 months, pervasive developmental disorder, active substance use disorder)\n* Declines or incapable of informed consent\n* Anticipated discharge to hospice, primary focus on palliative care, or \\>90% probability of in-hospital death",{"count":250,"type":21},[62],"A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.\n\nThe goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is this intervention feasible and acceptable in ARF patients?\n* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?\n\nParticipants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.",[647,25,648],"Respiratory Failure","Critical Illness",{"date":444,"type":41},{"date":651,"type":41},"2024-05-31",{"date":653,"type":21},"2028-09-01",{"name":655,"class":48},"Johns Hopkins University",{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":220,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":664,"conditions":665,"keywords":668,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":49},"100641433","test-anxiety-on-bowel-health-and-constipation-in-students-100641433","NCT07654959","Test Anxiety on Bowel Health and Constipation in Students","The Effect of Test Anxiety on Bowel Health and Constipation in University Students","Inclusion Criteria:\n\n* Being an undergraduate student in the Department of Physiotherapy and Rehabilitation at Lokman Hekim University\n* Being in the final examination period during the data collection process\n* Having sufficient reading and comprehension skills to complete the questionnaires independently\n* Voluntarily agreeing to participate in the study after reading and signing the informed consent form\n\nExclusion Criteria:\n\n* Having inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, celiac disease, colorectal cancer, or a history of major gastrointestinal surgery\n* Having diagnosed irritable bowel syndrome or another organic gastrointestinal disease\n* Regular use of laxatives or medications that directly affect bowel movements, such as opioids\n* Having neurological diseases that may affect bowel function, such as multiple sclerosis, Parkinson's disease, or spinal cord injury\n* Having had an acute gastrointestinal infection within the last month",{"count":20,"type":21},"This observational cross-sectional study aims to examine the relationship between test anxiety, bowel health, and constipation in university students. The study will include undergraduate students aged 18 years and older who are studying in the Physiotherapy and Rehabilitation Department at Lokman Hekim University and who are in their final examination period.\n\nParticipants will complete self-report questionnaires during a single face-to-face assessment session. Constipation status will be evaluated using the Rome IV criteria, stool form will be assessed using the Bristol Stool Scale, constipation severity will be assessed using the Constipation Severity Instrument, and test anxiety level will be assessed using the Test Anxiety Inventory. Sociodemographic characteristics and bowel-related symptoms will also be recorded.\n\nThe study does not include any intervention or treatment. The findings are expected to help better understand whether test anxiety during examination periods is associated with bowel health problems and constipation in university students.",[25,666,667],"Bowel Habits","Constipation",[669,670,671,672,673],"Test anxiety","Examination stress","Bowel health","Rome IV criteria","University students","2026-06-17",{"date":444,"type":41},{"date":677,"type":41},"2026-02-25",{"date":679,"type":21},"2027-02-25",{"name":681,"class":682},"Lokman Hekim University","OTHER_GOV"]