Participants with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. After the treatment period, participants will be followed monthly for 12 months.
This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
367
Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).
Happify Health (Remote)
New York, New York, United States
Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure to assess symptoms of depression
Time frame: baseline to end of treatment (8-10 weeks)
Generalized Anxiety Disorder-7 (GAD-7)
A 7-item self-report measure to assess symptoms of anxiety
Time frame: baseline to end of treatment (8-10 weeks)
PHQ-9
A 9-item self-report measure to assess symptoms of depression
Time frame: Through study completion, average of 14 months
GAD-7
A 7-item self-report measure to assess symptoms of anxiety
Time frame: Through study completion, average of 14 months
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