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

NCT05016050 | Completed FDA Device

• 1 other identifier: HPY-HPDT-DA-013-RWE-01
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Generalized Anxiety Disorder

Keywords

depression; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• PHQ-9

  Through study completion, average of 14 months

• GAD-7

  Through study completion, average of 14 months

Study Arms (1)

Digital therapeutic

EXPERIMENTAL

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

Device: HPDT-DA-013

Interventions

HPDT-DA-013 DEVICE

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

Digital therapeutic

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Happify Inc.: lead

Study Sites (1)

Happify Health (Remote)

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Roger Vilardaga, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: August 9, 2021
• Primary Completion: March 16, 2023
• Study Completion: April 14, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)