This proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Magpro X100, Axilium Cobot, Localite Camera
National University Hospital, Singapore
Singapore, Singapore
Beck Anxiety Inventory (BAI)
The primary outcome will be the response rate as defined as ≥50% reduction from baseline BAI scores pre- and post-iTBS treatment. BAI is an ordinal self-report scale measuring physical and cognitive anxiety symptoms ranging from 0-63. Higher scores mean worse outcome.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Beck Depression Inventory (BDI)
Change in BDI scores pre- and post-iTBS treatment. BDI is an ordinal self-report scale measuring depressive symptoms ranging from 0-63. Higher scores mean worse outcome.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Penn State Worry Questionnaire (PSWQ)
Change in PSWQ scores pre- and post-iTBS treatment. PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80. Scores depend on whether the item is worded positively or negatively.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)
Change in Mini-MASQ scores pre- and post-iTBS treatment. The Mini-MASQ is an orginal self-report scale measuring symptoms of anxiety and depression. Scores depend on whether the item is worded positively or negatively.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Hamilton Anxiety Rating Scale (HAM-A)
Change in HAM-A scores pre- and post-iTBS treatment. HAM-A is an ordinal clinician-rated scale measuring severity of psychic and somatic anxiety, ranging from 0-56. Higher scores mean a worse outcome.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
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Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
Change in IDAS-II scores pre- and post-iTBS treatment. IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symptoms ranging from 99-495. Higher scores mean worse outcome.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
Sheehan Disability Scale (SDS)
Change in SDS scores pre- and post-iTBS treatment. SDS is an ordinal self-report scale measuring how symptoms affect functional imapirment across work/ school, social life, and family/ home responsibilities, ranging from 0-10 for each domain. Higher scores mean a worse outcome.
Time frame: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.