NCT05016050

Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)

A Real-World Evidence, Single-Arm, Open-Label Study Evaluating the Safety and Efficacy of HPDT-DA-013 Digital Therapeutic in the Treatment of Major Depressive Disorder(MDD)and Generalized Anxiety Disorder(GAD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Happify Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Major Depressive Disorder
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DEVICE	HPDT-DA-013	Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).

Timeline

• Start date: 2021-08-09
• Primary completion: 2023-03-16
• Completion: 2023-04-14
• First posted: 2021-08-23
• Last updated: 2023-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study