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
351 participants
INTERVENTIONAL
2023-03-06
2024-02-28
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
DOUBLE
Study Groups
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Digital CBT
digitally-delivered CBT for anxiety accessed via mobile app
digital CBT
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
Psychoeducation
psychoeducation delivered via digital written materials
Psychoeducation
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.
Interventions
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digital CBT
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
Psychoeducation
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.
Eligibility Criteria
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Inclusion Criteria
* Score ≥15 on the 7-item Generalized Anxiety Disorder questionnaire (GAD-7)
* Diagnosis of GAD
* Current resident of the USA
* Oral and written fluency in English
* Regular access to the internet via a mobile or tablet device using Android ( 8 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, or current OCD
* Past 12 months alcohol or substance use disorder of moderate or greater severity
* Moderate or greater suicide risk
* 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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Boston University
OTHER
Big Health Inc.
INDUSTRY
Responsible Party
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Locations
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Boston University
Boston, Massachusetts, United States
Countries
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Other Identifiers
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BH-D-01
Identifier Type: -
Identifier Source: org_study_id
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