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Not yet recruiting NCT06598501

Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) for Gambling Disorder

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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) in the Management of Gambling Disorder in Indonesia: a Pilot and Feasibility Study

Overview

Treatment options for gambling disorder (GD) remain limited, with no pharmacotherapy proven effective. As of date, cognitive behavioral therapy (CBT) is the preferred therapy for GD, but the improvements often require months to show, highlighting the need for a more comprehensive therapy. Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment modality in alleviating craving. Studies have shown potential benefit of combining both CBT and rTMS in substance addiction, but not in GD. Thus, this study aims to determine the feasibility and efficacy of rTMS and CBT combination therapy in the management of GD in Indonesia.

Interventions

  • Device Repetitive Transcranial Magnetic Stimulation (rTMS)
    an open arm study of 10 gambling disorder subjects will be conducted to determine the efficacy and feasibility of a multimodalistic therapy of rTMS and Cognitive Behavioral Therapy (CBT) for gambling disorder in Indonesia.

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 18-70 years old
  • Subjects who understand Bahasa Indonesia
  • Subjects who agree to participate and receive treatment

Exclusion criteria

  • Subjects with history of psychotic disorder and personality disorder according to ICD-11
  • Subjects with severe neurological disorder comorbidities, which cause seizure or loss of consciousness
  • Subjects with intellectual disability
  • Subjects with history of neurostimulation
  • Subjects with history of medical implant
  • Subjects currently or expecting pregnancy
  • Subjects fulfilling diagnostic criteria of substance use disorder 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
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Siste K, Sen LT, Murtani BJ, Hanafi E, Kusuma KS, Aryani A, Schellekens A, van Eijndhoven P, Dalhuisen I, Biemans T. Utilizing repetitive transcranial magnetic stimulation in the management of gambling disorder in Indonesia: protocol for a pilot and feasibility study. Front Psychiatry. 2025 Sep 5;16:1658195. doi: 10.3389/fpsyt.2025.1658195. eCollection 2025. PMID 40980053

Identifiers

NCT: NCT06598501 · 34/IV/KS/05/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗