Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) for Gambling Disorder

NCT06598501 | Not Yet Recruiting

• 1 other identifier: 34/IV/KS/05/2023
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

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 (1)

rTMS and CBT

EXPERIMENTAL

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)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

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 18-70 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 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

Sponsors & Collaborators

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

Related Publications (1)

• Siste K, Sen LT, Murtani BJ, Hanafi E, Kusuma KS, Aryani A, Schellekens A, van Eijndhoven P, Dalhuisen I, Biemans T. Utilizing repetitive transcranial magnetic stimulation in the management of gambling disorder in Indonesia: protocol for a pilot and feasibility study. Front Psychiatry. 2025 Sep 5;16:1658195. doi: 10.3389/fpsyt.2025.1658195. eCollection 2025.

  PMID: 40980053 DERIVED

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

CONTACT

+6282110603921; kevinsurya97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: September 14, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share