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Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder

RecruitingNAAges 18 Years - anyAllAarhus University Hospital
NCT06989125 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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? The 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). The 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 mo

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📋 Eligibility rules (as published)
Inclusion Criteria: To be included patients should: * fulfil diagnostic criteria for GD (DSM-5). * score 4 points or more on the National Opinion Research Centre Screen for Gambling Problems (NODS). * be able to read, write, and speak Danish. * have IT skills and access to the internet and a computer, smartphone, and/or tablet. Exclusion Criteria: Patients are excluded from participation if they: * present with severe comorbid somatic disease, cognitive deficits, severe trauma, and/or psychiatric disorder (e.g. depression, bipolar disorder, substance abuse, ADHD) that is insufficiently treated at the time of assessment and/or is evaluated to constitute a barrier for engaging in or benefitting from treatment. * are not willing to engage in internet-delivered treatment or face-to-face cognitive behavioural therapy. * do not provide informed consent. * are in risk of suicide (indicated by clear intent and/or plans). * have previously received treatment via or had access to the SpilleFri platform. * seek treatment as part of an imminent legal case. * only fulfil diagnostic criteria for Gambling Disorder in relation to behaviour such as stock trading or buying and selling cryptocurrency. * present with highly unstable social circumstances, which are considered to potentially pose a barrier to engaging in treatment (e.g., homelessness).
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What it tests

  • Internet-based cognitive behavioral therapy
  • Synchronous cognitive behavioral therapy
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Where

1 site
Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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