Study Results
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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COMPLETED
NA
61 participants
INTERVENTIONAL
2023-08-31
2023-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Digital CBT
digitally-delivered CBT for depression accessed via mobile app
Digital CBT
An app-based intervention based on principles from cognitive behavioral therapy for depression.
Waitlist
Participants will wait for 5 weeks prior to receiving the intervention
Waitlist
Participants will wait for 5 weeks prior to receiving the intervention
Interventions
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Digital CBT
An app-based intervention based on principles from cognitive behavioral therapy for depression.
Waitlist
Participants will wait for 5 weeks prior to receiving the intervention
Eligibility Criteria
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Inclusion Criteria
* Score ≥10 and \<20 on the 8-item Patient Health Questionnaire (PHQ-8)
* Diagnosis of Major Depression
* Current resident of the USA
* Oral and written fluency in English
* Regular access to the internet via a mobile or tablet device using Android (5 or higher) or iOS (13 or higher)
* Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
Exclusion Criteria
* If on psychotropic medication, this must be stable for at least 60 days
* Past or present psychosis, schizophrenia, or bipolar disorder
* Moderate or greater suicide risk
* Treatment-resistant depression
* Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation
* Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
* Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities
22 Years
ALL
No
Sponsors
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Big Health Inc.
INDUSTRY
Responsible Party
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Locations
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Big Health Inc.
San Francisco, California, United States
Countries
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Other Identifiers
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BH-D-02
Identifier Type: -
Identifier Source: org_study_id
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