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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07081061
• Lead Sponsor: Teladoc Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-01
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment	90 days	Recruitment rates for study participation
Adherence	90 days	Adherence rates to study procedures

Secondary Outcome Measures

Name	Time	Method
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.