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
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.
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).
Parallel
Internet-based cognitive behavioral therapy
BehavioralThe 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. Treatment 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.
Synchronous cognitive behavioral therapy
BehavioralIn 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.
Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
Measured by Danish translation of The National Opinion Research Center Screen for Gambling Problems (NODS). 17 items with a minimum score of 0 and a maximum score of 10, with higher scores meaning more servere gambling problems. Self-report measure collected through a web-based questionnaire program. For the purpose of the study, the NODS is modified to assess the last month instead of the last year.
Change in Gambling Symptoms past week as Assessed by Gambling Symptom Assessment Scale (G-SAS)
The Gambling-Symptom Assessment Scale (G-SAS) is a 12-item self-rated measure that is designed to assess gambling symptom severity and change during treatment. Each item is scored on a 4-point scale from 0-4 with 0 meaning no symptoms and 4 meaning extreme symptoms. The total maximum score is 48.
Change in Self-reported Gambling Net Loss past week as assessed by a single item
Estimated net loss past week. Single-item self-report measure collected through a web-based questionnaire program.
Overall health improvement
Measured by the 5-point clinical global improvement scale (CGI). The CGI is measured by self-report (CGI\_p) and by clinician rating (CGI\_c). 1 item assessing overall improvement or worsening on a 5-point scale with a maximum score of 5 and a minimum score of 1, with higher scores meaning a better outcome. Self-report measure collected throguh a web-based questionnaire program.
Change in Symptoms of anxiety, depression, and psychological distress as Assessed by th SCL-90
Measured by 13 relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92). All items are rated on 5point scales. Maximum and minimum scores for the items are respectively 20 and 4 for anxiety, 30 and 6 for depression, and 40 and 8 for general distress, with higher scores meaning worse outcomes, i.e. more symptoms. Self-report collected through a web-based questionnaire program.
Gambling Motives as Assessed by the Gambling Motives Questionnaire-Financial (GMQ-F)
Measured by the Gambling Motives Questionnaire-Financial (GMQ-F). The scale is condensed by selecting the two items with the highest factor loadings from each subscale, resulting in a total of 8 items. The scale assesses four primary motives for gambling: coping, enhancement, social, and financial. Each gambling motive has a maximum score of 8 and a minimum score of 2, with higher scores meaning higher degree of endorsement of the motive. Respondents are categorized based on their primary gambling motives, i.e. the gambling motive that is rated with the highest score. Self-report measure collected through a web-based questionnaire program.
Gambling pathway subtype as Assessed by the Gambling Pathways Questionnaire, GPQ
Measured by the Gambling Pathways Questionnaire (GPQ). 48 items with a maximum score of 288 and a minimum score of 48. The scale assesses etiological risk factors for problem gambling and categorizes respondents into one of three etiological subtypes, based on which of the following categories are scored the highest: Behaviorally Conditioned, Emotionally Vulnerable, and Antisocial-Impulsive. Self-report measure collected through a web-based questionnaire program
Change in Maladaptive Gambling Cognitions as Assessed by the Gambling-Related Cognitions Scale
To measure maladaptive gambling cognitions and gambling related self-efficacy, a shortened version of the Gambling-Related Cognitions Scale (GRCS; Raylu \& Oei, 2004) is used. The scale is condensed by selecting the two items with the highest factor loadings from each subscale, resulting in a total of 10 items. On each of the five subscales, maximum scores of 14 indicate servere maladaptive cognitions, and minimum scores of 2 indicate no maladaptive cognitions.
Change in Difficulties in Emotion Regulation as Assessed by the DERS-16
To measure difficulties in emotion regulation, the Difficulties in Emotion Regulation Scale (DERS-16) is used. The DERS-16 consists of 16 five-point Likert-scale items, with maximum scores of 80 indicating servere difficulties and minimum scores of 16 indicating no difficulties.
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Aarhus University Hospital
Lead sponsor
University of Aarhus
Collaborator
