NCT06459128Completed
Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Outcomes: AI-Enabled App vs PDF Workbook
Comparison of Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Symptom Reduction: AI-Enabled App vs PDF Workbook
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 540 (actual)
- First submitted
- 10 Jun 2024
- Start date
- Jun 2024
- Primary completion date
- Jul 2024
- Lead sponsor
- Limbic Limited
- NCT number
- NCT06459128
What you commit to
- Study type: Interventional
- Participants enrolled: 540
- From Jun 2024 to the primary completion date, Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently undergoing mental health therapy
- Changed psychotropic medication in the past 8 weeks (this includes starting/stopping medication or increasing/decreasing dosage)
- Use recreational drugs more frequently than once per week
Other
- Self-identify as being at risk of harming themselves or others
- Have used the Limbic app before
- Consume \>= 10 alcohol units per week
Who the study is looking for
- Has a personal smartphone with Internet access with an accepted operating system: iOS (any) or Android (10 or later)
- Has a GAD-7 score \>= 8 OR a PHQ-9 score \>= 10 (indicating anxiety and/or depression symptoms above a clinical threshold, according to NHS Talking Therapies guidelines)
- US resident
- Fluent in English
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Limbic Limited Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.