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

Sponsor

Happify Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05016050

Collaborator

(none)

750

Enrollment

Location

Arm

31.7

Anticipated Duration (Months)

23.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Generalized Anxiety Disorder	Device: HPDT-DA-013	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Aug 9, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9) [baseline to end of treatment (8-10 weeks)]
A 9-item self-report measure to assess symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7) [baseline to end of treatment (8-10 weeks)]
A 7-item self-report measure to assess symptoms of anxiety

Secondary Outcome Measures

PHQ-9 [Through study completion, average of 14 months]
A 9-item self-report measure to assess symptoms of depression
GAD-7 [Through study completion, average of 14 months]
A 7-item self-report measure to assess symptoms of anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.