Depression, AnxietyNCT07081061
Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
A study testing BetterHelp in people with Depression, Anxiety and Mental Health Issue, run by Teladoc Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Mental Health Issue, Mental Health Wellness 2
- What is being tested?
- BetterHelp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Randomized Controlled Trial Evaluating the Effectiveness 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.
- Being tested
- BetterHelp
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetterHelpOther
Use program as needed for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants enrolled in a digital mental health platform, which provided access to licensed therapists, group therapy sessions, and a library of educational articles. Receives: Other: BetterHelp |
| Control | No intervention | Participants were not enrolled in a digital mental health platform, but continued their standard routine or care as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rates for study participation
Measured: 90 days
Adherence
Adherence rates to study procedures
Measured: 90 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 45 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start6 Oct 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teladoc Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BetterHelp
- Responsible party
- Sponsor
- Investigators
- Mindy Hong, PhD, MSPH, Principal investigator, BetterHelp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081061
- Sponsor's protocol ID
- BH2294015
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized Controlled Trial Evaluating the Effectiveness of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
- ClinicalTrials.gov ID
- NCT07081061
- Acronym / sponsor ID
- BH2294015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Teladoc HealthIndustry (pharma, biotech, devices)
- Collaborators
- BetterHelp
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: BetterHelpParticipants enrolled in a digital mental health platform, which provided access to licensed therapists, group therapy sessions, and a library of educational articles. |
| Control | No intervention | –Participants were not enrolled in a digital mental health platform, but continued their standard routine or care as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetterHelpUse program as needed for 16 weeks | Other | Intervention |
Primary outcome
Recruitment
Time frame: 90 days
Recruitment rates for study participation
Adherence
Time frame: 90 days
Adherence rates to study procedures
2 secondary outcomes
GAD-7
Time frame: Baseline, 45 days, 90 days
PHQ-9
Time frame: Baseline, 45 days, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mindy Hong, PhD, MSPH principal investigator
BetterHelp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BetterHelp in people with Depression, Anxiety and Mental Health Issue, run by Teladoc Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.