[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640968":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":68,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Sorlandet Hospital HF","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individual Metacognitive Therapy (MCT)","ACTIVE_COMPARATOR","Participants receive individual metacognitive therapy delivered by a trained clinician according to the established MCT protocol for generalized anxiety disorder. Treatment is provided weekly for 10 weeks, each session lasting approximately 45 minutes.",[13],"Behavioral: Individual Metacognitive Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group Metacognitive Therapy (g-MCT)","EXPERIMENTAL","Participants receive group-based metacognitive therapy delivered by two trained clinicians according to the established group MCT protocol for generalized anxiety disorder. Treatment is delivered in small groups of 4-6 participants meeting weekly for 10 weeks. Each session lasts approximately 90 minutes.",[19],"Behavioral: Group Metacognitive Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Individual Metacognitive Therapy","Individual metacognitive therapy (MCT) is delivered by a trained clinician following the established protocol for generalized anxiety disorder. The treatment focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and promoting flexible attentional control. Participants receive 10 weekly individual sessions, each lasting approximately 45 minutes. The intervention targets excessive worry, unhelpful coping strategies, and beliefs about the uncontrollability and danger of worry.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Group Metacognitive Therapy","Group Metacognitive Therapy (g-MCT) is delivered by two trained clinicians following the established group MCT protocol for generalized anxiety disorder. Treatment is provided in small groups of 4-6 participants and focuses on modifying maladaptive metacognitive beliefs, reducing the cognitive-attentional syndrome (CAS), and improving attentional flexibility. Participants attend 10 weekly sessions, each lasting approximately 90 minutes.",[15],[32],{"name":33,"affiliation":34,"role":35},"Gunvor Launes, MD, PhD","Sørlandet Hospital HF","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Gunvor Launes, MD Phd","CONTACT","+4747661428","Gunvor.Launes@sshf.no",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Anna Sorte Grindvik, MD","+4797771807","Anna.Sorte.Grindvik@sshf.no",[47,61],{"facility":34,"status":48,"city":49,"state":50,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Kristiansand","Agder","Norway","NO",{"type":54,"coordinates":55},"Point",[56,57],7.9956,58.14671,{"lat":57,"lon":56},[60],{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"facility":34,"status":48,"city":49,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},{"type":54,"coordinates":63},[56,57],{"lat":57,"lon":56},[66],{"name":67,"role":39,"phone":26,"phoneExt":26,"email":45},"Anna Grindvik, MD",{"type":69,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640968","group-vs-individual-metacognitive-therapy-for-generalized-anxiety-disorder-100640968",false,"NCT07579897","Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder","Generalized Anxiety Disorder: A Randomized Non-inferiority Trial Comparing Group Metacognitive Therapy With Individual Metacognitive Therapy","Inclusion Criteria:\n\nAdults with a primary diagnosis of generalized anxiety disorder (GAD). GAD-7 score ≥ 10 at screening\u002Fbaseline. Participants must endorse that they experience problems with excessive worry\n\nExclusion Criteria:\n\n1. Bipolar disorder;\n2. Psychosis;\n3. Ongoing substance abuse\u002Fdependence;\n4. Intellectual disability based on previous medical history;\n5. Eating disorder in need of medical attention;\n6. Unwillingness to refrain from anxiolytic drugs during the treatment;\n7. Current suicidal ideation with plan and intent;\n8. Taking an unstable dose of antidepressant, with recent dose-change within the last 4 weeks;\n9. Known cluster A or B personality disorder;\n10. Serious medical comorbidity (e.g.: cancer, severe renal failure)\n11. Language difficulties in need of an interpreter.","ALL","18 Years",{"count":80,"type":81},64,"ESTIMATED","INTERVENTIONAL",[84],"NA","Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients.\n\nThis randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries.\n\nThe main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care.\n\nThis will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.",[87],"Generalized Anxiety Disorder",[87,89,90,91,92,28,23,93,94,95,96,97,98,99,100,101],"GAD","Anxiety","Metacognitive Therapy","MCT","Worry","Psychotherapy","RCT","Randomized Controlled Trial","Anxiety Treatment","Group Therapy","Adult Mental Health","Cognitive Attentional Syndrome","CAS","2026-05-06",{"date":104,"type":105},"2026-05-12","ACTUAL",{"date":107,"type":105},"2026-03-27",{"date":109,"type":81},"2028-12",{"name":5,"class":6},2]