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

Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia: A Randomized Controlled 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 60 subjects would be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and CBT for online gambling disorder.

Study Overview

• Status: Not yet recruiting
• Conditions: Gambling Disorder
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS and CBT; During 5 weeks of therapy, the subjects will undergo 12 CBT sessions combined with 15 rTMS procedures lasting about 30-60 minutes.	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.
Sham Comparator: Sham and CBT; During 5 weeks of therapy, the subjects will undergo 12 CBT sessions combined with 15 rTMS procedures (coil replaced with sham) lasting about 30-60 minutes.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling
• Other Study ID Numbers: KET-1499-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No