Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Outcomes: AI-Enabled App vs PDF Workbook
NCT ID: NCT06459128
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
540 participants
INTERVENTIONAL
2024-06-05
2024-07-17
Brief Summary
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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.
Detailed Description
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Homework is a crucial component of cognitive-behavioral therapy (CBT) as it allows patients to actively implement therapeutic techniques and skills outside of sessions, promoting long-term mental health improvements. However, patient engagement with CBT homework can be challenging due to a lack of motivation, forgetfulness, or a lack of personalization, which can hinder the overall effectiveness of the therapy and retention in a therapy program.
Design
This randomized controlled trial (RCT) aims to evaluate the efficacy, acceptability, and safety of an AI-enabled smartphone application (Limbic Care) compared to a standard digital workbook (PDF format) in delivering cognitive behavioral therapy (CBT) materials to individuals with clinically significant symptoms of anxiety and/or depression. The study will involve 500 participants, who will be randomly allocated in a 3:2 ratio to either the intervention group (Limbic Care app) or the control group (PDF workbook).
A large cohort (\~2,000 participants) will initially be screened for inclusion and exclusion criteria. Eligible participants will be invited to participate in a baseline survey (capped at 550 to account for attrition and reach a target of 500 participants for the final data collection point). This survey will measure multiple validated symptom scales (e.g., for anxiety, depression, obsessive-compulsive disorder, health anxiety disorder) and gather subjective ratings on variables such as familiarity with CBT, previous experience with mental health apps, preferences for apps vs. PDF workbooks, medication status, and more.
After the baseline survey, participants will be randomly allocated to one of the two experimental arms and invited to download the app (intervention group) or to access the PDF workbook via a weblink (control group). Over a 6-week period, participants will be asked to engage with their assigned materials (app or workbook) for a specified number of days each week. Weekly surveys will measure changes in anxiety (GAD-7) and depression (PHQ-9) symptoms, as well as any new adverse health events. Additionally, engagement metrics such as time spent using the app or viewing workbook pages will be automatically recorded.
Outcome Measures
The primary outcomes are changes in GAD-7 and PHQ-9 scores from baseline to week 6, measured weekly. We will also use engagement (operationalised as the time spent with the materials, as well as the number of exercises interacted with) as a primary outcome, with the aim of investigating whether this is a mediating factor for any effect of material format (app vs workbook) on symptom reduction.
The secondary outcome is the incidence of adverse health events, to estimate and compare the safety of each material format.
Additional outcome measures include changes in the Work and Social Adjustment Scale (WSAS), self-reported satisfaction and acceptability, perceived utility and effectiveness, motivation to engage with the materials, and changes in sleep quality (measured by the Mini Sleep Questionnaire, MSQ).
Data Analysis
Data will be analyzed using appropriate statistical methods to compare the intervention and control groups. Primary and secondary outcomes will be analyzed using repeated measures ANOVA or mixed-effects models, adjusting for baseline scores and potential confounders. Subgroup analyses will be conducted to explore the effects of demographic variables on treatment outcomes.
Ethics and Safety
The study has been approved by the UCL research ethics committee and will be conducted in accordance with the Declaration of Helsinki. Participants' safety and confidentiality will be prioritized throughout the study. Adverse events will be closely monitored, and participants will have the option to withdraw from the study at any time without penalty.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AI-Enabled Mobile Application (Limbic Care)
Participants are given access to Limbic Care, a smartphone application that uses conversational AI to deliver cognitive behavioral therapy interventions and psychoeducation, provide support through active listening, and help answer questions about the therapeutic material.
Limbic Care
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.
Digital Workbook (PDF)
Participants are provided with a link to the digital workbook (in PDF format) that can be accessed via the Internet. The workbook contains cognitive behavioral therapy interventions and psychoeducation material.
Digital Workbook
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).
Interventions
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Limbic Care
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.
Digital Workbook
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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Changed psychotropic medication in the past 8 weeks (this includes starting/stopping medication or increasing/decreasing dosage)
* Self-identify as being at risk of harming themselves or others
* Have used the Limbic app before
* Use recreational drugs more frequently than once per week
* Consume \>= 10 alcohol units per week
18 Years
ALL
Yes
Sponsors
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Limbic Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Max Rollwage, PhD
Role: PRINCIPAL_INVESTIGATOR
Limbic
Locations
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Limbic Limited
London, Greater London, United Kingdom
Countries
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Other Identifiers
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LC-2024Q2-01
Identifier Type: -
Identifier Source: org_study_id