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)

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Major Depressive Disorder
• Intervention / Treatment: Device: HPDT-DA-013

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.

• Study Type: Interventional
• Enrollment (Actual): 367
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Happify Health (Remote)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults 22 years or older at the time of screening
2. Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder
3. Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration
4. Currently residing in the United States

Key Exclusion Criteria:

1. Risk of suicide or has attempted suicide within 24 months of the screening visit
2. Moderate to severe substance use disorder
3. Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder
4. Currently pregnant or planning to become pregnant during the treatment period

Note: Other protocol-defined inclusion/exclusion criteria applied.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital therapeutic; Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks.	Device: HPDT-DA-013; Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	A 9-item self-report measure to assess symptoms of depression	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	baseline to end of treatment (8-10 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9	A 9-item self-report measure to assess symptoms of depression	Through study completion, average of 14 months
GAD-7	A 7-item self-report measure to assess symptoms of anxiety	Through study completion, average of 14 months

Collaborators and Investigators

• Sponsor: Happify Inc.
• Investigators: Principal Investigator: Roger Vilardaga, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: depression; anxiety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID Numbers: HPY-HPDT-DA-013-RWE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes