Generalized Anxiety Therapy Effectiveness (GATE)

Big Health

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Other: Psychoeducation; Device: digital CBT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05748652

BH-D-01

Details and patient eligibility

About

This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.

Full description

This study aims to examine the effectiveness of app-based digital CBT for anxiety compared to psychoeducation in individuals with a diagnosis of Generalized Anxiety Disorder. The primary outcomes are anxiety symptom reduction and remission after 10 weeks.

Enrollment: 351 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥22 years old
• 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

• 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)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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351 participants in 2 patient groups

Digital CBT

Experimental group

Description:

digitally-delivered CBT for anxiety accessed via mobile app

Treatment:

Device: digital CBT

Psychoeducation

Active Comparator group

Description:

psychoeducation delivered via digital written materials

Treatment:

Other: Psychoeducation