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

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

Interventions

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. 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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Aarhus

  collaborator OTHER

• Aarhus University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-24

Primary Completion

2027-01-31

Completion

2027-06-30

Countries

• Denmark

Study Locations