Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia

Gambling Disorder Clinical Trial

Official title:

Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182137
• Other study ID #: KET-1499-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 60 subjects would be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and CBT for online gambling disorder.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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, 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

Related Conditions & MeSH terms

• Gambling
• Gambling Disorder

Intervention

Device:
• Repetitive 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Primary	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.	Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Primary	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.	Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Primary	Improvement in gambling related cognitive distortions	Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome.	Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Primary	improvement in harm caused by gambling	Victorian Gambling Screen Scale (VGS), with 3 domains: (1) enjoyment of gambling (0-12), (2) harm to partner (0-6), and harm to self (0-60). Lower score in each domain indicates a better outcome.	Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Secondary	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.	Baseline (week 0), post-intervention (week 6)
Secondary	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.	Baseline (week 0), post-intervention (week 6)
Secondary	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.	Baseline (week 0), post-intervention (week 6)