Gambling Disorder
Conditions
Brief summary
Treatment options for gambling disorder (GD) remain limited, with no pharmacotherapy proven effective. As of date, cognitive behavioral therapy (CBT) is the preferred therapy for GD, but the improvements often require months to show, highlighting the need for a more comprehensive therapy. Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment modality in alleviating craving. Studies have shown potential benefit of combining both CBT and rTMS in substance addiction, but not in GD. Thus, this study aims to determine the feasibility and efficacy of rTMS and CBT combination therapy in the management of GD in Indonesia.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
an open arm study of 10 gambling disorder subjects will be conducted to determine the efficacy and feasibility of a multimodalistic therapy of rTMS and Cognitive Behavioral Therapy (CBT) for gambling disorder in Indonesia.
Sponsors
Radboud University Medical Center
Indonesia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with pathological gambling (SOGS score ≥ 5) * Subjects aged 18-70 years old * Subjects who understand Bahasa Indonesia * Subjects who agree to participate and receive treatment
Exclusion criteria
* Subjects with history of psychotic disorder and personality disorder according to ICD-11 * Subjects with severe neurological disorder comorbidities, which cause seizure or loss of consciousness * Subjects with intellectual disability * Subjects with history of neurostimulation * Subjects with history of medical implant * Subjects currently or expecting pregnancy * Subjects fulfilling diagnostic criteria of substance use disorder in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
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. |
Contacts
Primary ContactKevin Surya Kusuma
Outcome results
None listed