Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BetterHelp.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety, Mental Health Issue, Mental Health Wellness 2. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Feasibility Randomized Controlled Trial Evaluating the Effectiveness of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
Overview
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.
Interventions
- Other BetterHelp
Use program as needed for 16 weeks
Primary outcome measures
- Recruitment [Time frame: 90 days]
- Adherence [Time frame: 90 days]
Secondary outcome measures (2)
- GAD-7 [Time frame: Baseline, 45 days, 90 days]
- PHQ-9 [Time frame: Baseline, 45 days, 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07081061 · BH2294015