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

NCT06182137 | Not Yet Recruiting

• 1 other identifier: KET-1499-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gambling Disorder

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• 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

• Improvement in depression symptoms

  Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention

• Improvement in self-reported psychological distress

  Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention

• 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

Study Arms (2)

rTMS and CBT

EXPERIMENTAL

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)

Sham and CBT

SHAM COMPARATOR

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)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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 and CBT; rTMS and CBT

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Gambling

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Kevin Surya Kusuma, MD

CONTACT

+6282110603921; kevinsurya97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ID (1)