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

NCT ID: NCT07081061

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Depression, Anxiety Mental Health Issue Mental Health Wellness 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

BetterHelp

Intervention Type OTHER

Use program as needed for 16 weeks

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BetterHelp

Use program as needed for 16 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BetterHelp

UNKNOWN

Sponsor Role collaborator

Teladoc Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mindy Hong, PhD

Role: PRINCIPAL_INVESTIGATOR

Teladoc Health

Central Contacts

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Mindy Hong, PhD

Role: CONTACT

615-498-8308

Mona Barman, PhD

Role: CONTACT

Other Identifiers

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BH2294015

Identifier Type: -

Identifier Source: org_study_id

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