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

Primary Purpose

Major Depressive Disorder, Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPDT-DA-013
Sponsored by
Happify Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, anxiety

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Happify Health (Remote)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digital therapeutic

Arm Description

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

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure to assess symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7)
A 7-item self-report measure to assess symptoms of anxiety

Secondary Outcome Measures

PHQ-9
A 9-item self-report measure to assess symptoms of depression
GAD-7
A 7-item self-report measure to assess symptoms of anxiety

Full Information

First Posted
August 16, 2021
Last Updated
May 31, 2023
Sponsor
Happify Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05016050
Brief Title
Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Happify Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Generalized Anxiety Disorder
Keywords
depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital therapeutic
Arm Type
Experimental
Arm Description
Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks.
Intervention Type
Device
Intervention Name(s)
HPDT-DA-013
Intervention Description
Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
A 9-item self-report measure to assess symptoms of depression
Time Frame
baseline to end of treatment (8-10 weeks)
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
A 7-item self-report measure to assess symptoms of anxiety
Time Frame
baseline to end of treatment (8-10 weeks)
Secondary Outcome Measure Information:
Title
PHQ-9
Description
A 9-item self-report measure to assess symptoms of depression
Time Frame
Through study completion, average of 14 months
Title
GAD-7
Description
A 7-item self-report measure to assess symptoms of anxiety
Time Frame
Through study completion, average of 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 22 years or older at the time of screening Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration Currently residing in the United States Key Exclusion Criteria: Risk of suicide or has attempted suicide within 24 months of the screening visit Moderate to severe substance use disorder Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder Currently pregnant or planning to become pregnant during the treatment period Note: Other protocol-defined inclusion/exclusion criteria applied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Vilardaga, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Happify Health (Remote)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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