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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorIndonesia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: rTMS and CBTExperimental treatment 1 intervention
Group B: Sham and CBTSham comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Radboud University Medical Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: