Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06989125

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

Led by Aarhus University Hospital · Updated on 2025-05-25

150

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

Sponsors

A

Aarhus University Hospital

Lead Sponsor

U

University of Aarhus

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fulfil diagnostic criteria for Gambling Disorder (DSM-5)
  • Score 4 points or more on the National Opinion Research Centre Screen for Gambling Problems (NODS)
  • Able to read, write, and speak Danish
  • Have IT skills and access to the internet and a computer, smartphone, and/or tablet
Not Eligible

You will not qualify if you...

  • Severe untreated comorbid somatic disease, cognitive deficits, severe trauma, or psychiatric disorders that prevent treatment engagement or benefit
  • Unwilling to participate in internet-delivered or face-to-face cognitive behavioural therapy
  • Do not provide informed consent
  • At risk of suicide with clear intent or plans
  • Previously received treatment via or had access to the SpilleFri platform
  • Seeking treatment as part of an imminent legal case
  • Gambling behavior limited to stock trading or cryptocurrency buying/selling
  • Highly unstable social circumstances that may prevent treatment engagement (e.g., homelessness)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark, Denmark, 8000

Actively Recruiting

Loading map...

Research Team

A

Anna W Stenbro, Master's degree in Psychology

CONTACT

L

Lisbeth Frostholm, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here