An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Gambling Disorder, sponsored by Indonesia University. Not yet recruiting. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 10 is below the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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During 5 weeks of therapy, the subjects will undergo 12 CBT sessions (30-40 minutes) combined with 15 rTMS procedures (20 minutes).
Device: Repetitive 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.
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.
Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
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.
Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
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.
Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Improvement in gambling related cognitive distortions
Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome.
Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
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.
Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
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.
Time frame: Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention
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.
Time frame: Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention
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.
Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.
Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 2 months is below that.
Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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