About this trial
Research has shown that cognitive-behavioral therapy (CBT) is an effective treatment for gambling disorder. Several studies had also been done to evaluate the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in addiction management, particularly in alleviating craving. A randomised controlled trial (RCT) of 30 subjects would be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and CBT for online gambling disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with pathological gambling (SOGS score ≥ 5)
Subjects aged 18-59 years old
Subjects who understand Bahasa Indonesia
Subjects who agree to participate and receive treatment
Disqualifiers
Subjects with history of psychotic disorder, personality disorder, or sleep disorder according to ICD-11
Subjects with history of neurostimulation
Subjects with history of medical implant
Subjects with history of severe neurological disorder, which causes seizure or loss of consciousness
Trial design
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceA randomised controlled trial (RCT) of 60 subjects will be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and Cognitive Behavioral Therapy (CBT) for online gambling disorder.
Treatment groups
Trial outcomes
Primary outcomes
Improvement in pathological gambling score
South Oaks Gambling Screen (SOGS), Indonesian version, with minimum score of 0 and maximum score of 20. A score of 0-2 indicates no pathological gambling; a score of 3-4 indicates problems with gambling, and a score of 5 or more indicates that the subject is a probable pathological gambler. Lower score indicates a better outcome.
Improvement in gambling symptoms severity
Gambling Symptoms Assessment Scale (G-SAS), Indonesian version, with minimum score of 0 and maximum score of 48. Interpretations: Mild (8-20), Moderate (21-30), Severe (31-40), and Extreme (41-48). Lower score indicates a better outcome.
Improvement in gambling urge
Gambling Urge Scale (GUS), Indonesian version, with minimum score of 0 and maximum score of 42. Lower score indicates a better outcome.
Improvement in gambling related cognitive distortions
Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome.
Secondary outcomes
Improvement in gambling-related cognitive functions
Creyos (formerly Cambridge Brain Sciences, CBS), measures 12 domains of cognitive function with the subject results compared with their respective average age results in percentile. A higher percentile is a better outcome.
Improvement in depression symptoms
Beck Depression Inventory-II (BDI II), measures severity of depression symptoms, with minimum score of 0 and maximum score of 63. Interpretation: (1) minimal (0-13), (2) mild (14-19), (3) moderate (20-28), and (4) severe (29-63). Lower score indicates a better outcome.
Improvement in self-reported psychological distress
20-item Self-Reporting Questionnaire (SRQ-20), Indonesian version, measures non-specific psychological distress. Score range 0-20, with scores \>10 classified as mental distress. Lower score indicates a better outcome.
Improvement of overall severity of illness
Clinical Global Impression (CGI), measure overall severity of illness and improvement observed by the clinician. Lower score indicates a better outcome.
Sponsors and contacts
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Indonesia University
Lead sponsor
Radboud University Medical Center
Collaborator
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