Anxiety and Fear-Related Disorders
Conditions
Keywords
Anxiety, Neuronavigated, iTBS, Accelerated
Brief summary
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.
Interventions
Magpro X100, Axilium Cobot, Localite Camera
Sponsors
National University Hospital, Singapore
National University of Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male/ female aged ≥ 21 years and ≤ 70 years * Diagnosis of an anxiety-related disorder as validated by the MINI (Specifically, the types of anxiety-related disorders are: generalized anxiety disorder; panic disorderl social anxiety disorder; obsessive compulsive disorder; post-traumatic stress disorder; agoraphobia; anxiety disorder due to another medical condition; other specified anxiety disorders; and unspecified anxiety disorder.) * Non-response to adequate trial (4 weeks) of at least two anxiety medication as verified by the study clinician, or psychotherapy for anxiety * BAI score of 16 or above * Able to give informed consent * Able to understand English
Exclusion criteria
* DSM-5 psychotic disorder * Significant personality disorder which may hinder the progress of this study * Drug or alcohol abuse or dependency (preceding 3 months) * Rapid clinical response required, e.g., high suicide risk * Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy * Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pumps or any other electronic implants/ devices * Tattoos containing derromagnetic ink or permanent piercings * Currently wearing dental braces * Pregnancy * Unsuitable for MRI or TMS for any other reasons * With recent TMS or ECT treatment within the past 3 months * Currently on multiple stimulant medications (2 or more) * Participant does not have the capacity to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory (BAI) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
| Penn State Worry Questionnaire (PSWQ) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
| Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
| Hamilton Anxiety Rating Scale (HAM-A) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
| Inventory of Depression and Anxiety Symptoms-II (IDAS-II) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
| Sheehan Disability Scale (SDS) | Baseline, immediately post-treatment, 1-month and 3-months post-intervention. | 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. |
Countries
Singapore
Contacts
CONTACTPhern Chern Tor, MBBS
Outcome results
None listed