[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602574":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":35,"collaborators":19,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":19,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":19,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":19,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":19},{"fullName":5,"class":6},"Region Stockholm","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Exposure based CBT",[13],"Behavioral: Exposure based CBT",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","This intervention is an exposure-based CBT program developed for children with blood-injection-injury (BII) phobia and a co-occurring somatic illness. The treatment includes a structured home training kit with medical materials (e.g., syringes, swabs) related to the child's fear, enabling frequent and realistic exposure exercises at home between sessions, guided by parents. This allows for higher treatment intensity and continuity. The intervention is tailored to children who require regular medical procedures and whose phobia interferes with essential care. Unlike previous studies, this model integrates both clinical sessions and structured home practice to increase adherence and reduce fear in medical settings.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Mike Kemani, PhD","Karolinska Universitetssjukhuset, Region Stockholm","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Elisabet Werneman, Licensed Psychologist","CONTACT","+46739497718","elisabet.werneman@regionstockholm.se",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Charlotte Gentili, Licensed Psychologist, PhD","+46760482895","charlotte.s.gentili@regionstockholm.se",{"type":24,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Charlotte S Gentili","Lic Psychologist, PhD","100602574","exposure-based-cbt-for-youth-with-blood-and-injection-phobia-and-chronic-illness-100602574",false,"NCT07125287","Exposure-Based CBT for Youth With Blood and Injection Phobia and Chronic Illness","\"Confront the Fear\" - Evaluation of a Novel Exposure-Based CBT for Youth With Blood and Injection Phobia and Concurrent Somatic Illness Requiring Injections","Inclusion Criteria:\n\n1. Age 12-17 years;\n2. Blood-Injection-Injury (BII) phobia;\n3. Somatic disease or condition requiring regular injections and\u002For blood sampling;\n4. Ability to read and write in Swedish.\n\nExclusion Criteria:\n\n1. Significant cognitive or intellectual impairment;\n2. Severe psychopathology (e.g., suicidality);\n3. Acute trauma;\n4. Ongoing or recently completed treatment for BII phobia.","ALL","12 Years","17 Years",{"count":49,"type":50},30,"ESTIMATED","INTERVENTIONAL",[53],"NA","More than half of all children fear needles, and hospitalized children often describe injections as the most frightening part of medical care. While mild needle fear can often be managed by healthcare staff using distraction and reassurance, these strategies are ineffective for children with blood-injection-injury phobia (BII phobia). Children with BII phobia and co-occurring chronic medical conditions often require repeated blood tests or injections, but their phobia may prevent essential treatment. In such cases, healthcare providers may be forced to use physical restraint, sedation, or general anesthesia-approaches that are distressing for the child and costly for the healthcare system.\n\nAlthough exposure-based cognitive behavioral therapy (CBT) is an effective treatment for specific phobias in adults, there is very limited research on CBT for children with BII phobia, particularly those with serious medical conditions. At the Department of Behavioral Medicine at Karolinska University Hospital, we have developed an exposure-based CBT intervention tailored for children with BII phobia and co-occurring somatic illness. The program includes a home-based training kit with medical materials to support frequent and realistic exposure between clinic sessions. Clinical experience suggests the intervention improves fear responses and increases medical treatment adherence, but it has not yet been formally evaluated.\n\nThis study aims to evaluate the feasibility and effectiveness of this novel CBT intervention for children and adolescents with disabling BII phobia and chronic somatic conditions.",[56,57],"Blood Injury Phobia","Injection Fear",[59,60,61],"Phobia exposure","CBT","Needle exposure practice kit for home use","NOT_YET_RECRUITING","2025-08-12",{"date":65,"type":66},"2025-08-15","ACTUAL",{"date":68,"type":50},"2025-09-01",{"date":70,"type":50},"2027-12-31",{"name":5,"class":6}]