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

NCT ID: NCT06598501

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS and CBT

During 5 weeks of therapy, the subjects will undergo 12 CBT sessions (30-40 minutes) combined with 15 rTMS procedures (20 minutes).

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Kristiana Siste

Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kevin Surya Kusuma

Role: CONTACT

kevinsurya97@gmail.com

+6282110603921

References

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.

Reference Type: DERIVED

PMID: 40980053 (View on PubMed)

Other Identifiers

34/IV/KS/05/2023

Identifier Type: -

Identifier Source: org_study_id