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NCT Number: NCT07081061

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

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Mental Health Issue Mental Health Wellness 2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BetterHelp

Other

Use program as needed for 16 weeks

Primary outcomes

  1. Recruitment

    Time frame: 90 days

    Recruitment rates for study participation

  2. Adherence

    Time frame: 90 days

    Adherence rates to study procedures

Secondary outcomes

  1. GAD-7

    Time frame: 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.

  2. PHQ-9

    Time frame: 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.

Other outcomes

  1. Workplace Productivity

    Time frame: Baseline, 45 days, 90 days

    Workplace productivity will be measured by the Work Productivity and Activity Impairment Questionnaire (WPAI) and reported for both groups.

  2. Sleep

    Time frame: Baseline, 45 days, 90 days

    Sleep quality will be measured by the Jenkins Sleep Scale (JSS-4) and reported for both groups.

  3. Stress

    Time frame: Baseline, 45 days, 90 days

    Stress levels will be measured by the Perceived Stress Scale (PSS-10) and reported for both groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Mindy Hong, PhD

CONTACT

[email protected]

615-498-8308

Mona Barman, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Teladoc Health

Industry

Collaborators

  • BetterHelp

Registry information

Official study title

A Feasibility Randomized Controlled Trial Evaluating the Effectiveness of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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