Frontlight ResearchEarly access
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