Clinical trial NCT06598501: Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) for Gambling Disorder
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
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: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

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:
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