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CompletedNo phase

Generalized Anxiety Therapy Effectiveness

Key facts

Who runs it
Big Health Inc.
Where
Boston, United StatesSee the site
Trial code
Status
Completed
People taking part
351 people enrolled
Started
6 Mar 2023
Ended
28 Feb 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • digital CBT
  • Psychoeducation
Record updated
5 April 2024

Who can take part

Age
22 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Moderate or greater suicide risk

Where in United States

  • Boston UniversityBoston, United States

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Digital CBTTreatment being tested

    digitally-delivered CBT for anxiety accessed via mobile app

  • PsychoeducationExisting treatment, for comparison

    psychoeducation delivered via digital written materials

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
Publications
Record updated
5 April 2024