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Purpose

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

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Digital CBT 		digitally-delivered CBT for anxiety accessed via mobile app
  • Device: digital CBT
    An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
Active Comparator
Psychoeducation 		psychoeducation delivered via digital written materials
  • Other: Psychoeducation
    Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.

More Details

Status
Completed
Sponsor
Big Health Inc.

Study Contact

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.