Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
A Feasibility Randomized Controlled Trial Evaluating the Effectiveness of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
1 other identifier
interventional
86
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJuly 23, 2025
July 1, 2025
2 months
July 15, 2025
July 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Recruitment
Recruitment rates for study participation
90 days
Adherence
Adherence rates to study procedures
90 days
Secondary Outcomes (2)
GAD-7
Baseline, 45 days, 90 days
PHQ-9
Baseline, 45 days, 90 days
Other Outcomes (3)
Workplace Productivity
Baseline, 45 days, 90 days
Sleep
Baseline, 45 days, 90 days
Stress
Baseline, 45 days, 90 days
Study Arms (2)
Intervention
EXPERIMENTALParticipants enrolled in a digital mental health platform, which provided access to licensed therapists, group therapy sessions, and a library of educational articles.
Control
NO INTERVENTIONParticipants were not enrolled in a digital mental health platform, but continued their standard routine or care as needed.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teladoc Healthlead
- BetterHelpcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mindy Hong, PhD
Teladoc Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2025
First Posted
July 23, 2025
Study Start
August 1, 2025
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share