Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety

Teladoc Health

Status: Not yet enrolling

Conditions: Depression, Anxiety; Mental Health Issue; Mental Health Wellness 2

Treatments: Other: BetterHelp

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07081061

BH2294015

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants enrolled in a digital mental health platform, which provided access to licensed therapists, group therapy sessions, and a library of educational articles.

Treatment:

Other: BetterHelp

Control

No Intervention group

Description:

Participants were not enrolled in a digital mental health platform, but continued their standard routine or care as needed.