RecruitingNot Applicable

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

Denmark150 participantsStarted 2025-02-24

Plain-language summary

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 months after end-of-treatment. In 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. Participants will: * Engage in nine structured modules of either internet-based CBT or sCBT * Complete self-reported questionnaires on gambling severity and secondary symptoms at eight time points * Have the option for up to three additional support sessions with a psychologist

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)

Timeframe: Baseline, 12 weeks/18 weeks (post treatment SpilleFri/sCBT), 24 weeks/30 weeks (3 month FU SpilleFri/sCBT), 64 weeks/70 weeks (12 month FU SpilleFri/sCBT)

Trial details

NCT IDNCT06989125

SponsorAarhus University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Anna W Stenbro, Master's degree in Psychology

+4541622166 anna.stenbro@rm.dk