Digital CBT + Psychoeducation for Generalized Anxiety Disorder
(GATE Trial)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Big Health Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
Research Team
Eligibility Criteria
This trial is for adults over 22 in the USA with Generalized Anxiety Disorder (GAD), who score at least 15 on the GAD-7 questionnaire, speak English, and have regular internet access via a modern mobile device. Excluded are those with certain mental health conditions like psychosis or bipolar disorder, recent CBT/ACT therapy for anxiety, unstable medication use, substance abuse issues within the last year, or sensory impairments affecting digital content use.Inclusion Criteria
You need to have a smartphone or tablet with internet access using Android 8 or higher or iOS 13 or higher.
Adults aged ≥22 years old
You have been diagnosed with generalized anxiety disorder (GAD).
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Exclusion Criteria
You have had or currently have mental health conditions like psychosis, schizophrenia, bipolar disorder, or obsessive-compulsive disorder (OCD).
You have a condition that affects your ability to think or learn, which would make it difficult for you to understand and follow the study instructions.
Must not be currently receiving or be expecting to start psychological treatment for anxiety during study participation, or have previously received Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for anxiety in the past 6-months (self-report)
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Treatment Details
Interventions
- digital CBT (Cognitive Behavioral Therapy)
- Psychoeducation (Behavioural Intervention)
Trial OverviewThe study compares two methods to treat anxiety: digital Cognitive Behavioral Therapy (CBT) and psychoeducation. Participants will be randomly assigned to one of these treatments to see which is more effective at reducing symptoms of generalized anxiety.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital CBTExperimental Treatment1 Intervention
digitally-delivered CBT for anxiety accessed via mobile app
Group II: PsychoeducationActive Control1 Intervention
psychoeducation delivered via digital written materials
Find a Clinic Near You
Who Is Running the Clinical Trial?
Big Health Inc.
Lead Sponsor
Trials
12
Recruited
139,000+
Boston University
Collaborator
Trials
494
Recruited
9,998,000+
Sophie Kornowski
Boston University
Chief Executive Officer since 2022
MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University
Dr. Patrizia Cavazzoni
Boston University
Chief Medical Officer
MD from McGill University