Theta Burst Stimulation for Gambling Disorder
ConditionGambling Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTaipei City Hospital
About this trial
The goal of this clinical trial is to investigate the efficacy of theta burst stimulation in individuals with gambling disorder. The main goal is to compare the severity of gambling problems following 2 weeks of intervention between active group and sham group. Participants will be randomized into active and sham group. The severity of gambling problems are assessed by self-reported questionaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 18 and 65 years;
fulfilling at least 4 of the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of gambling disorder for at least 12-month assessed by the Structured Clinical Interview
Disqualifiers
Inability to provide informed consent or comprehend the study procedure;
A major psychiatric illness that required chronic psychotropic medication or inpatient treatment, including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features.
A current DSM-5 diagnosis of substance use disorder except nicotine use disorder or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants.
Trial design
Design model
Parallel
Treatments tested in this trial
theta burst stimulation
DeviceMagstim Rapid 2 Plus stimulator (Magstim Co., Ltd., Whitland, United Kingdom)
sham stimulation
Devicesham stimulation
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Active armExperimental treatment 1 intervention
Group B: Sham armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in gambling craving
Measured by visual analog scale, from 0-10
Time frame
Before intervention (week 0) and after intervention (week 2, 4)2
Change in gambling severity
Measured by Gambling Symptom Assessment Scale, from 0-48
Time frame
Before intervention (week 0) and after intervention (week 2, 4)Secondary outcomes
1
Change in depression severity
Measured by Beck Depression Inventory, from 0-63
Time frame
Before intervention (week 0) and after intervention (week 2, 4)2
Change in anxiety severity
Measured by Beck Anxiety Inventory, from 0-63
Time frame
Before intervention (week 0) and after intervention (week 2, 4)Sponsors and contacts
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Source ClinicalTrials.gov