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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2023-04-14

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder Generalized Anxiety Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital therapeutic

Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks.

Group Type EXPERIMENTAL

HPDT-DA-013

Intervention Type DEVICE

Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).

Interventions

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HPDT-DA-013

Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No