Generalized Anxiety Disorder, Major Depressive Disorder
Conditions
Keywords
depression, anxiety
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.
Interventions
DEVICEHPDT-DA-013
Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).
Sponsors
Happify Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed