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Not yet recruitingNCT06182137Updated Sep 19, 2024

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

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Gambling Disorder, sponsored by Indonesia University. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gambling Disorder

Browse trials for

03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 128 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

  • Sham comparator
    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

  • DeviceRepetitive 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Improvement in gambling related cognitive distortions

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

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

Secondary outcomes

  1. Improvement in gambling-related cognitive functions

    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.

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

  2. Improvement in depression symptoms

    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.

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

  3. Improvement in self-reported psychological distress

    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.

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

  4. Improvement of overall severity of illness

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

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

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2024; primary completion for Jun 2025, 6 months later.

Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 6 months is below that.

Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2023
First posted
Dec 26, 2023
StartEst.
Dec 2024
Primary completionEst.
Jun 2025
CompletionEst.
Dec 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06182137
Responsible party
Kristiana Siste (Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University, Indonesia University) — Principal investigator
First posted
Dec 26, 2023
Start date
Dec 2024 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Kevin Surya Kusuma, MD
Contact
kevinsurya97@gmail.com
+6282110603921

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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