Clinical trial NCT06182137: Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gambling Disorder
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2023-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Improvement in pathological gambling score
timeFrame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
measure: Improvement in gambling symptoms severity
timeFrame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
measure: Improvement in gambling urge
timeFrame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
measure: Improvement in gambling related cognitive distortions
timeFrame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Secondary outcomes:
measure: Improvement in gambling-related cognitive functions
timeFrame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
measure: Improvement in depression symptoms
timeFrame: Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention
measure: Improvement in self-reported psychological distress
timeFrame: Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention
measure: Improvement of overall severity of illness
timeFrame: Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Jakarta
Study officials:
References: