Gambling Disorder
Conditions
Brief summary
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
A 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.
Sponsors
Radboud University Medical Center
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Subjects with intellectual disability * Subjects with endocrinological disorders * Subjects with contraindication during prior MR or other related procedures * Subjects who are currently or expecting pregnancy * Subjects with history of substance use in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in pathological gambling score | Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention | 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 | Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention | 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 | Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention | 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 | Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention | Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in gambling-related cognitive functions | Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention | 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 | Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention | 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 | Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention | 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 | Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention | Clinical Global Impression (CGI), measure overall severity of illness and improvement observed by the clinician. Lower score indicates a better outcome. |
Countries
Indonesia
Contacts
Primary ContactKevin Surya Kusuma, MD
Outcome results
None listed