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

Teladoc Health86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Depression, Anxiety Mental Health Issue Mental Health Wellness 2

Interventions

BetterHelpOTHER

Use program as needed for 16 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

BetterHelp

San Jose, California, United States

Outcomes

Primary Outcomes

Recruitment

Recruitment rates for study participation

Time frame: 90 days

Adherence

Adherence rates to study procedures

Time frame: 90 days

Secondary Outcomes

GAD-7

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.

Time frame: Baseline, 45 days, 90 days

PHQ-9

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.

Time frame: Baseline, 45 days, 90 days

Data from ClinicalTrials.gov

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