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Not yet recruiting NCT06182137

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

No phase Interventional Gambling Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS).
Who it may be relevant to
Registry conditions: Gambling Disorder. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia: A Randomized Controlled Trial

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Improvement in pathological gambling score [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention]
Secondary outcome measures (4)
  • Improvement in gambling-related cognitive functions [Time frame: 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 [Time frame: Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention]
  • Improvement in self-reported psychological distress [Time frame: Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention]
  • Improvement of overall severity of illness [Time frame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Universitas Indonesia — Jakarta Pusat

Identifiers

NCT: NCT06182137 · KET-1499-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗