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

NCT06989125 | Recruiting

• 3 other identifiers: 1-10-72-145-24DLK-2308_0022023-4552
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gambling Disorder

Keywords

Gambling Disorder treatment; Internet-based treatment; Cognitive behavioral therapy; Non-inferiority trial; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Secondary Outcomes (7)

• Change in Gambling Symptoms past week as Assessed by Gambling Symptom Assessment Scale (G-SAS)

  Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)

• Change in Self-reported Gambling Net Loss past week as assessed by a single item

  Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)

• Overall health improvement

  Post (week 12/18, clinician rating), 3 month FU (week 24/30, participant and clinician rating)

• Change in Symptoms of anxiety, depression, and psychological distress as Assessed by th SCL-90

  Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)

• Change in Overall Quality of Life and General Health Satisfaction as Assessed by the WHOQoL

  Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)

Other Outcomes (10)

• Gambling Motives as Assessed by the Gambling Motives Questionnaire-Financial (GMQ-F)

  Baseline

• Gambling pathway subtype as Assessed by the Gambling Pathways Questionnaire, GPQ

  Baseline

• Change in Maladaptive Gambling Cognitions as Assessed by the Gambling-Related Cognitions Scale

  Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)

Study Arms (2)

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"

Behavioral: Internet-based cognitive behavioral therapy

Synchronous cognitive behavioral therapy (sCBT)

ACTIVE COMPARATOR

Participants in this arm receive traditional synchronous cognitive behavioral therapy, face-to-face or via video-connection

Behavioral: Synchronous cognitive behavioral therapy

Interventions

Internet-based cognitive behavioral therapy BEHAVIORAL

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. 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.

Also known as: SpilleFri

Internet-based cognitive behavioral therapy ("SpilleFri")

Synchronous cognitive behavioral therapy BEHAVIORAL

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.

Also known as: Face-to-face CBT

Synchronous cognitive behavioral therapy (sCBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Central Study Contacts

Anna W Stenbro, Master's degree in Psychology

CONTACT

+4541622166; anna.stenbro@rm.dk

Lisbeth Frostholm, Professor

CONTACT

+4522618875; lisbeth.frostholm@aarhus.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: May 25, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)