Depression, Anxiety, Mental Health Issue, Mental Health Wellness 2
Conditions
Brief summary
A digital mental health intervention (BetterHelp, Mountain View, CA) provides users with access to online therapy care for treatment of depression and anxiety. This feasibility randomized controlled trial compares clinical outcomes of an intervention group, who will enroll in the digital mental health platform, to a control group.
Interventions
OTHERBetterHelp
Use program as needed for 16 weeks
Sponsors
Teladoc Health
BetterHelp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Has moderate or severe baseline anxiety or depression, as defined by GAD-7 ≥ 10 or PHQ-9 ≥ 10, respectively * Based in the US * Fluent in the English language * Has an email account to receive and complete online surveys * Has access to a smartphone, tablet or computer * Able to understand and provide informed consent
Exclusion criteria
* Pregnant or plan on becoming pregnant in the next 6 months * Has no or mild baseline anxiety or depression, as defined by GAD-7 \< 10 and PHQ-9 \< 10, respectively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 90 days | Recruitment rates for study participation |
| Adherence | 90 days | Adherence rates to study procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GAD-7 | Baseline, 45 days, 90 days | Anxiety will be measured by the Generalized Anxiety Disorder Scale (GAD-7), ranging from 0 (no anxiety) to 21 (severe anxiety). The percentage of participants who achieved a minimal clinically important difference (MCID) of 4 points or more will also be reported for each group, as based on literature. |
| PHQ-9 | Baseline, 45 days, 90 days | Depression will be measured by the Patient Health Questionnaire (PHQ-9), ranging from 0 (no depression) to 27 (severe depression). The percentage of participants who achieved a minimal clinically important difference (MCID) of 5 points or more will also be reported for each group, as based on literature. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMindy Hong, PhD, MSPH
BetterHelp
Outcome results
None listed