[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distress":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100650418","phase-1-ai-dbt-for-serious-illness-100650418",false,"NCT07748312","AI-DBT For Serious Illness","Pilot Testing AI-Delivered Dialectical Behavioral Therapy Skills and Coaching in Older Patients With Serious Illness","Inclusion Criteria:1) Aged 60+, 2) diagnosis of serious, life limiting illness including stage 4 breast, prostate, or colon cancer; stage 3b or 4 lung or blood cancer, New York Heart Association Stage 3 or 4 CHF, or COPD with hypercapnia74 or CKD stage 4 or ESRD; 3) psychological distress rated 4 or higher on the distress thermometer;75-77 4.) has access to a mobile phone and 5.) speaks English or Spanish fluently.\n\n\\-\n\nExclusion Criteria:\n\n\\-","ALL","60 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Lay \u002F General Audience Summary Many older adults living with serious illnesses experience high levels of emotional distress, including anxiety, sadness, fear, and feeling overwhelmed. These feelings often worsen as illness progresses and can make physical symptoms harder to manage, reduce quality of life, and increase the use of medications. Unfortunately, many people with serious illness cannot access mental health care because there are not enough providers, services are hard to reach, appointments are physically exhausting, or care is not available in their language.\n\nThis study will test a new way of delivering emotional support that does not require in-person therapy. The program teaches practical coping skills that help people manage strong emotions and stress. These skills are delivered through short videos and daily supportive check-ins using an automated phone or text system that people can use from home. The system is available in many languages and can be used on basic mobile phones, making it accessible to a wide range of patients.\n\nWe will enroll older adults with serious illnesses such as cancer, heart disease, lung disease, or kidney disease who are experiencing emotional distress. Participants will be randomly assigned to receive either their usual medical care alone or usual care plus the new skills program. We will examine whether people find the program easy to use, helpful, and acceptable, and whether it improves their confidence in managing difficult emotions and reduces distress.\n\nThe goal of this project is to develop a low-burden, widely accessible way to support emotional well-being for people living with serious illness. If successful, this approach could expand access to mental health support for patients who currently have few options.",[26,27,28],"Serious Illness","Distress, Emotional","Distress",[30,31,32,33,34],"serious illness","mental health","AI","DBT","distress","NOT_YET_RECRUITING","2026-08-03",{"date":38,"type":39},"2026-08-05","ACTUAL",{"date":41,"type":20},"2026-10-01",{"date":43,"type":20},"2028-05-15",{"name":45,"class":46},"Rutgers, The State University of New Jersey","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100604338","embrace-your-power-100604338","NCT07148219","EMBRACE YOUR POWER","Embrace Your Power: A VR Journey to Overcoming Negative Emotions for Romanian Youth","EYP-VR","Inclusion Criteria:\n\n* Students 5th and 6th grade\n* Students whose parents have given their consent and who have also agreed to participate in the program\n\nExclusion Criteria:\n\n* Medical problems that have VR-based procedures as contraindicated because they can induce dizziness, seizures, nausea:\n\n  1. epilepsy\n  2. presence of seizures\n  3. severe motion sickness- vestibular disorders\n  4. significant vision problems that would interfere with the use of the headset\n  5. severe migraines triggered by exposure to screens\n* Neurodevelopmental disorders\n\n  1. Autism spectrum disorder- level 3 of severity or sensory processing disorders\n  2. ADHD, if hyperactivity would prevent the student from staying in the exercise for longer\n* Points a) and b) do not represent automatic exclusion criteria, because depending on the judgment of the school counselor, the parent and the teacher, it is possible that a participant will be able to complete the program.\n* Severe mental disorders: psychotic spectrum disorders, post-traumatic stress disorder, present suicidal ideation\n* If children have an extremely low level of literacy perceived by the teacher and counselor, and this aspect would prevent them from participating in the program.\n* Parallel participation in other bullying prevention programs.",true,"10 Years","14 Years",{"count":59,"type":20},300,[61],"NA","The goal of this randomized controlled trial is to test the effectiveness of an educational tool, based on virtual reality (VR), for preventing and combating bullying and for improving the emotional well-being of pre-adolescent students.\n\nParticipants will be allocated to one of two conditions:\n\n* (1) intervention group: Embrace your power intervention for combating bullying;\n* (2) waitlist (inactive control): the control group receives intervention after the study ends.\n\nThe intervention group will be compared to the control group in terms of peer aggression and victimization (bullying behaviors) and emotional symptoms.",[64,28,65],"Bullying","Bullying Victimisation",[67,68,69,34],"randomized controlled trial","bullying","virtual reality","2025-08-22",{"date":72,"type":39},"2025-08-29",{"date":74,"type":20},"2025-10",{"date":76,"type":20},"2027-01",{"name":78,"class":46},"University of Bucharest",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":55,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100594554","effect-of-laughter-therapy-on-breast-cancer-patients-100594554","NCT07020962","Effect of Laughter Therapy on Breast Cancer Patients","The Effect of Laughter Therapy on Distress, Depression and Psychological Well-being in Breast Cancer Patients Before Surgical Intervention: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Voluntary acceptance to participate in the study,\n* Being diagnosed with breast cancer and being in the patient group in which surgical operation is planned,\n* Not having participated in laughter yoga practice before,\n* Being literate,\n* Not having a psychiatric disease (diagnosis)\n* Not having a communication and understanding disability related to vision, hearing\n* Being in the age group of 18 and over\n\nExclusion Criteria:\n\n* Not wanting to participate in the study,\n* Being in the patient group with a condition recommended not to do laughter yoga (having undergone surgery in the abdominal region in the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy),\n* Not having participated in any of the laughter yoga sessions,\n* Having physical restriction\u002Frespiratory problems and not being able to perform yoga movements.","18 Years","100 Years",{"count":90,"type":20},56,[61],"The aim of this study is to examine the effect of laughter therapy applied to breast cancer patients before surgical intervention on distress, depression and psychological well-being of patients.\n\nThis research will be carried out as an experimental research with a randomised control group.\n\nThe population of the study will consist of breast cancer patients diagnosed with breast cancer in a city hospital and scheduled for surgery in the breast-endocrine surgery clinic. The research will be carried out with patients who meet the inclusion criteria and agree to participate in the study. The sample size for the study was calculated using the G\\* Power 3.1.9.7 programme (Faul et al., 2007). In the calculation, since there was no similar study for two-way mixed design analysis of variance, the required sample size was calculated as 48, 24 in each group, based on the medium effect size (effect size f=0.25), 5% margin of error (alpha=0.05), inter-measurement correlation value 0.5 and 80% power (1-β=0.80). Considering the data losses, the number was increased by 20% and a total of 56 patients in the intervention and control groups constituted the sample of the study.\n\nHypothesis(es):\n\nH1: The effect of laughter therapy applied to breast cancer patients on distress over time is different in the experimental and control groups.\n\nH2: The effect of laughter therapy applied to breast cancer patients on depression over time is different in the experimental and control groups.\n\nH3: The effect of laughter therapy applied to breast cancer patients on psychological well-being according to time is different in experimental and control groups.\n\nIn obtaining the research data; Personal Information Form, Distress Thermometer, Psychological well-being scale prepared by the researchers in line with the literature will be used.\n\nThe research data will be collected face-to-face through data collection forms from breast cancer patients diagnosed with breast cancer and scheduled for surgery in the breast-endocrine surgery clinic. Individuals who agree to participate in the study and meet the inclusion criteria will be assigned to the experimental and control groups by providing randomisation. Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined by https:\u002F\u002Fwww.randomizer.org\u002F over the internet. Group 1: Intervention Group, Group 2: Control Group. Data collection tools will be applied to the individuals in the experimental and control groups as a pre-test. Individuals in the experimental group will receive laughter therapy three days a week for 30-45 minutes (6 sessions). Individuals in the control group will receive only standard nursing care. Data collection tools will be applied to the individuals in both groups for post-test, 1 and 3-month follow-up tests immediately after all laughter sessions with the experimental group are completed.",[94,95,96,28,97],"Laughter Therapy","Psychological Well-being","Breast Cancer","Depression",[99,100,101,34,102],"breast cancer","psychological well-being","depression","laughter therapy","2025-06-12",{"date":105,"type":39},"2025-06-13",{"date":107,"type":20},"2025-06-25",{"date":109,"type":20},"2025-10-30",{"name":111,"class":46},"Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization"]