At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Symptom Reduction: AI-Enabled App vs PDF Workbook
In Brief
A clinical study evaluating Limbic Care and Digital Workbook for Mental Health Issue. Completed, enrolled 540 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to compare two different ways of delivering cognitive behavioral therapy (CBT) materials to people with symptoms of anxiety and depression. The main questions it aims to answer are: 1. Do people using the app experience greater reductions in anxiety and depression symptoms compared to those using the workbook? 2. Does the personalization offered by the app increase engagement with CBT materials compared to the workbook? Participants will be given access to either the Limbic Care app or an equivalent PDF workbook and will be asked to engage with the materials for several days each week over a period of 6 weeks. Each week, participants will complete a survey about their anxiety and depression symptoms and report any new health issues and their experiences with the materials.
Study Details
Timeline
Interventions
Limbic Care is an AI-enabled smartphone application that delivers cognitive behavioral therapy (CBT) interventions and psychoeducation to users via an interactive, conversational interface using AI. Participants can choose from three "courses" (sleep, worry, and low mood) that sets the type of content they will see in the app. For each course, different interventions and psychoeducation material will appear in the "to do list" section of the app on a fixed schedule. The app also allows users to engage in open-ended conversation with the AI, which serves as an non-interventional, empathetic listener.
The digital workbook in PDF format will be provided to participants via the Internet. Participants can choose from three workbooks that each focus on a different topic: sleep, worry, and low mood. Each workbook contains psychoeducation material and CBT intervention worksheets, consisting of text, images, and response boxes to write in (if printed out).