[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592107":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":34,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":34,"enrollmentInfo":78,"targetDuration":34,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Aarhus University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Internet-based cognitive behavioral therapy (\"SpilleFri\")","EXPERIMENTAL","Participants in this arm receive internet-based cognitive behavioral therapy via the therapist-guided online treatment platform \"SpilleFri\"",[13],"Behavioral: Internet-based cognitive behavioral therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Synchronous cognitive behavioral therapy (sCBT)","ACTIVE_COMPARATOR","Participants in this arm receive traditional synchronous cognitive behavioral therapy, face-to-face or via video-connection",[19],"Behavioral: Synchronous cognitive behavioral therapy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Internet-based cognitive behavioral therapy","The internet-based CBT treatment arm is delivered via the online treatment platform \"SpilleFri\" and consists of nine internet-delivered modules delivered over 10-12 weeks. Modules contain written assignments and multiple-choice lists, combined with psychoeducation delivered in text, illustrations, and videos. The treatment is assisted by a therapist. The therapist contact is primarily written and takes place in an embedded secured message system on the platform. Participants can use the written message function whenever they want, and the therapist will respond on a specific day each week. Further, participants are offered up to three sessions of face-to-face or video-based therapist support during the treatment, depending on their preference.\n\nTreatment is regarded as completed if the participant has worked actively (logged in to the module and filled in at least one interactive exercise) in the first 6 modules of the treatment program.",[9],[27],"SpilleFri",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Synchronous cognitive behavioral therapy","In the sCBT condition, participants receive 9 individual sessions spread over 14-20 weeks, in a 1 to 1 format with a therapist, delivered either face-to-face or via video connection, depending on the participant's preference (there may be a mix). Treatment sessions take place weekly at the start of the course. After week 4, the aim is to have sessions at least every other week to maintain continuity in treatment. Further, participants are offered up to three additional sessions that can be included on request of participant or when therapists deem it necessary. Treatment is regarded as completed if the participant has attended 6 sessions of the treatment program.",[15],[33],"Face-to-face CBT",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Anna W Stenbro, Master's degree in Psychology","CONTACT","+4541622166","anna.stenbro@rm.dk",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Lisbeth Frostholm, Professor","+4522618875","lisbeth.frostholm@aarhus.rm.dk",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":49,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Aarhus","Denmark","8000","DK",{"type":53,"coordinates":54},"Point",[55,56],10.21076,56.15674,{"lat":56,"lon":55},[59,61],{"name":60,"role":38,"phone":39,"phoneExt":34,"email":40},"Anna W Stenbro, Master's degree in Psychology,",{"name":42,"role":62,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Lisbeth Frostholm","Professor",[67],{"name":68,"class":6},"University of Aarhus","100592107","internet-based-versus-synchronous-cognitive-behavioural-therapy-for-patients-with-gambling-disorder-100592107",false,"NCT06989125","Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder","Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder: A Non-inferiority Randomized Controlled Trial","Inclusion Criteria:\n\nTo be included patients should:\n\n* fulfil diagnostic criteria for GD (DSM-5).\n* score 4 points or more on the National Opinion Research Centre Screen for Gambling Problems (NODS).\n* be able to read, write, and speak Danish.\n* have IT skills and access to the internet and a computer, smartphone, and\u002For tablet.\n\nExclusion Criteria:\n\nPatients are excluded from participation if they:\n\n* present with severe comorbid somatic disease, cognitive deficits, severe trauma, and\u002For psychiatric disorder (e.g. depression, bipolar disorder, substance abuse, ADHD) that is insufficiently treated at the time of assessment and\u002For is evaluated to constitute a barrier for engaging in or benefitting from treatment.\n* are not willing to engage in internet-delivered treatment or face-to-face cognitive behavioural therapy.\n* do not provide informed consent.\n* are in risk of suicide (indicated by clear intent and\u002For plans).\n* have previously received treatment via or had access to the SpilleFri platform.\n* seek treatment as part of an imminent legal case.\n* only fulfil diagnostic criteria for Gambling Disorder in relation to behaviour such as stock trading or buying and selling cryptocurrency.\n* present with highly unstable social circumstances, which are considered to potentially pose a barrier to engaging in treatment (e.g., homelessness).","ALL","18 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"NA","The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. The main question it aims to answer is: Is the effect of the internet-based CBT (\"SpilleFri\") non-inferior to that of synchronous CBT in reducing gambling severity?\n\nThe trial will enroll 150 patients with Gambling Disorder who will be randomized (1:1) to either the experimental condition (12 weeks' treatment with the internet-based treatment \"SpilleFri\") or the active control condition (18 weeks individual sCBT). The primary outcome measure will be based on self-reported GD severity (NODS).\n\nThe trial will be considered effective if SpilleFri is not clinically inferior (within a predefined non-inferiority margin) to sCBT in reducing GD severity at the primary endpoint three months after end-of-treatment.\n\nIn addition to evaluating the effectiveness of the treatments, the study will conduct an exploratory analysis of the impact of each condition on secondary outcomes (changes in gambling behavior, relationship quality, and symptoms of anxiety, depression, and emotional distress). Similarly, an exploratory analysis of process variables (gambling-related self-efficacy, maladaptive gambling cognitions, emotion regulation difficulties, and gambling urge) will be conducted across conditions and clinical subgroups.\n\nParticipants will:\n\n* Engage in nine structured modules of either internet-based CBT or sCBT\n* Complete self-reported questionnaires on gambling severity and secondary symptoms at eight time points\n* Have the option for up to three additional support sessions with a psychologist",[86],"Gambling Disorder",[88,89,90,91,92],"Gambling Disorder treatment","Internet-based treatment","Cognitive behavioral therapy","Non-inferiority trial","Randomized controlled trial","2025-05-16",{"date":95,"type":96},"2025-05-25","ACTUAL",{"date":98,"type":96},"2025-02-24",{"date":100,"type":80},"2027-06",{"name":5,"class":6},1]