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NCT Number: NCT06182137

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

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.

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Key information

Conditions

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

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location contact

Kevin Surya Kusuma

CONTACT

+6282110603921

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    Gambling Urge Scale (GUS), Indonesian version, with minimum score of 0 and maximum score of 42. Lower score indicates a better outcome.

  4. 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

    Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome.

Secondary outcomes

  1. 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

    Creyos (formerly Cambridge Brain Sciences, CBS), measures 12 domains of cognitive function with the subject results compared with their respective average age results in percentile. A higher percentile is a better outcome.

  2. Improvement in depression symptoms

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

    Beck Depression Inventory-II (BDI II), measures severity of depression symptoms, with minimum score of 0 and maximum score of 63. Interpretation: (1) minimal (0-13), (2) mild (14-19), (3) moderate (20-28), and (4) severe (29-63). Lower score indicates a better outcome.

  3. 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

    20-item Self-Reporting Questionnaire (SRQ-20), Indonesian version, measures non-specific psychological distress. Score range 0-20, with scores >10 classified as mental distress. Lower score indicates a better outcome.

  4. 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

    Clinical Global Impression (CGI), measure overall severity of illness and improvement observed by the clinician. Lower score indicates a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Surya Kusuma, MD

CONTACT

[email protected]

+6282110603921

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Radboud University Medical Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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