To evaluate the superiority of cognitive behavioral therapy using the Aurora® digital medical device + conventional drug treatment, compared to conventional drug treatment alone, in reducing anxiety symptoms, as assessed by the change in the GAD-7 scale at 12 weeks of treatment, relative to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks
81 patients using conventional pharmacological treatment for 12 weeks
Servicios Especializados En Ensayos Clinicos, Seec, Sc
Mexico City, Mexico City, Mexico
RECRUITINGGAD-7 scale
Changes in the initial versus final GAD-7 scale in both treatment arms. Values 0 to 21 points. A decrease in the GAD 7 scale signifies patient improvement
Time frame: 12 weeks
Penn State Worry Questionnaire (PSWQ)
Change From Baseline in the Penn State Worry Questionnaire (PSWQ) in week 4, 8 and 12. Changes in the initial versus final PSWQ scale in both treatment arms. Values 16 to 80 points. A decrease in the PSWQ scale signifies patient improvement.
Time frame: 4, 8 and 12 weeks
PHQ-9 (Patient Health Questionnaire-9)
Change From Baseline in PHQ-9 (Patient Health Questionnaire-9) in week 4, 8 and 12 . Changes in the initial versus final PHQ-9 scale in both treatment arms. Values 0 to 27 points. A decrease in the PHQ-9 scale signifies patient improvement.
Time frame: 4, 8 and 12 weeks
Adverse event
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 12 weeks
Adverse incident
Number of Participants With Treatment-Related Incident Events as Assessed
Time frame: 12 weeks
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