The goal of this clinical trial is to learn if treatment with the BTL-699-2 device (non-invasive repetitive transcranial magnetic stimulation) can decrease anxiety symptoms in adults (aged 22 years and older) diagnosed with Generalized Anxiety Disorder (GAD). The main questions it aims to answer are: Does the accelerated treatment protocol using the BTL-699-2 device reduce self-reported anxiety symptoms (as measured by the GAD-7 scale) 3 months after the final treatment? What are the safety and side effects associated with the use of the BTL-699-2 device during this accelerated protocol? Researchers will compare the active treatment group (Group A, receiving stimulation intensity of up to 70% of the individual's motor threshold) to a sham control group (Group B, receiving an inactive stimulation intensity of 5% of their motor threshold) to see if the active brain stimulation works to treat Generalized Anxiety Disorder. Participants will: * Attend a screening/baseline visit to confirm GAD diagnosis (using the MINI diagnostic interview), review medical history, and establish their individual motor threshold. * Complete 8 study treatment visits scheduled twice weekly (2 to 4 days apart) over approximately 4 weeks. Each visit will consist of two consecutive 19-minute treatment sessions delivered at least 15 minutes apart (for a total of 16 treatments). * Complete self-reported and clinician-reported questionnaires assessing anxiety (GAD-7, HAM-A), depressive symptoms (PHQ-9), well-being (WEMWBS), suicidal risk (CSSRS), clinical improvement (CGI-I, PGI-I), and treatment comfort/satisfaction (TCQ, SSQ) at designated baseline, treatment, and follow-up visits. * Undergo a urine pregnancy test at baseline and once weekly (every other treatment visit) if they are women of childbearing potential. * Attend 2 follow-up visits scheduled at 1 month and 3 months after the final treatment to evaluate long-term outcomes and safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Participants will receive sixteen transcranial magnetic stimulation treatment sessions during 8 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 80% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
Participants will receive sixteen transcranial magnetic stimulation treatment sessions during 8 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 5% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
Aria Integrative Health
Denver, Colorado, United States
RECRUITINGThe Study by AC
Chicago, Illinois, United States
RECRUITINGCady Wellness Institute
Newburgh, Indiana, United States
RECRUITINGEvaluation of the change in self-reported anxiety symptoms 3 months post-treatment.
Evaluation of the change in self-reported anxiety symptoms based on the Generalized Anxiety Disorder Assessment (GAD-7). The GAD-7 baseline score will be compared to the 3-month follow-up score. The 3-month score change will be compared between the active and sham groups. Subjects rate seven symptoms based on their frequency over the preceding two-week period. Each item is scored from 0 (not at all) to 3 (nearly every day), resulting in a total score range of 0 to 21, with higher scores indicating greater anxiety severity.
Time frame: Baseline and 3 months
Evaluation of the change in self-reported depressive symptoms.
The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 3-month follow-up score. The total score from this 9-item questionnaire ranges from 0 to 27, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.
Time frame: baseline and 3 monhts
Evaluation of the change in clinician-reported anxiety symptoms.
Change in the score obtained from Hamilton Anxiety Rating Scale (HAM-A). It consists of 14 items, each defined by a series of symptoms, measuring both psychic anxiety and somatic anxiety. Each item is scored from 0 (not present) to 4 (very severe), with a total score of 0 to 56. Higher scores indicate greater anxiety severity.
Time frame: baseline and 3 months
Evaluation of clinician's impression of improvement.
Change in the score obtained from the Clinical Global Impression - Improvements questionnaire (CGI-I). The CGI-I is a 7-point scale (1= very much improved, 7= very much worse), using which the clinician assesses how much the subject's condition has improved or worsened relative to the baseline state before the treatments. Lower scores indicate greater outcomes.
Time frame: baseline and 3 months
Evaluation of the self-reported impression of improvement
Change in the score obtained from the Patient Global Impression - Improvement (PGI-I). PGI-I is a 7-point scale (1= very much better, 7= very much worse), used to assess the subject's perceived change of their condition relative to the baseline state before the treatments. Lower scores indicate greater outcomes.
Time frame: baseline and 3 months
Evaluation of the change in mental well-being
The change in the score obtained from the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). The score ranges from 14 to 70, with higher scores indicating greater mental well-being and quality of life.
Time frame: Baseline and 3 months
Evaluation of Subject Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction Questionnaire. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicates better outcomes.
Time frame: last treatment and both follow-ups
Evaluation of Therapy Comfort
Therapy Comfort questionnaire consists of two questions and will be used for evaluating the comfort and pain during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. The first question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicates higher therapy comfort. The second question includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.
Time frame: Last Treatment
Evaluation of the safety of the treatment
The occurrence of adverse events will be followed throughout the whole study and evaluated.
Time frame: from baseline to 3-months follow-up
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