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

NCT ID: NCT06182137

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gambling Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Kristiana Siste

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Kevin Surya Kusuma, MD

Role: CONTACT

+6282110603921

Facility Contacts

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Kevin Surya Kusuma

Role: primary

+6282110603921

Other Identifiers

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KET-1499-2023

Identifier Type: -

Identifier Source: org_study_id

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