Mental Health IssueNCT06459128
Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Outcomes: AI-Enabled App vs PDF Workbook
A study testing Limbic Care and Digital Workbook in people with Mental Health Issue, run by Limbic Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Limbic Care and Digital Workbook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2024to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently undergoing mental health therapy
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Symptom Reduction: AI-Enabled App vs PDF Workbook
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:
- Do people using the app experience greater reductions in anxiety and depression symptoms compared to those using the workbook?
- 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.
Read the detailed description
Motivation
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
- Mental Health Issue
- Being tested
- Limbic Care, Digital Workbook
- Keywords
- ai, llm, cbt, cognitive behavioural therapy, cognitive behavioral therapy, artificial intelligence, large language model, app, cbt-i, homework, limbic, worksheets, workbook, cbt intervention
- Medical subject headings
- Color Vision Defects, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limbic CareDevice
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 WorkbookDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| AI-Enabled Mobile Application (Limbic Care) | Experimental | 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. Receives: Device: Limbic Care |
| Digital Workbook (PDF) | Active comparator | 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. Receives: Device: Digital Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GAD-7 (Anxiety)
The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item self-report questionnaire used to screen for and measure the severity of generalized anxiety disorder (GAD).
Measured: Baseline to Week 6, and weekly (from Baseline to Week 6)
Change in PHQ-9 (Depression)
The PHQ-9 (Patient Health Questionnaire-9) is a 9-item self-report screening and diagnostic tool for depression.
Measured: Baseline to Week 6, and weekly (from Baseline to Week 6)
Therapy Completion
Proportion of therapy content viewed (exercises in-app, or PDF pages viewed)
Measured: Summed across Week 1 to Week 6
Engagement Duration
Time spent in the Limbic Care application (intervention) or viewing workbook pages (control).
Measured: Summed across Week 1 to Week 6
Secondary outcomes (1)
Incidence of Adverse Health Events
Self-reported incidence of any adverse health events (physical or mental) experienced in the past week.
Measured: Summed across Week 1 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start5 Jun 2024
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limbic Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Max Rollwage, PhD, Principal investigator, Limbic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459128
- Sponsor's protocol ID
- LC-2024Q2-01
- Status last verified
- Dec 2024
- First submitted
- 10 Jun 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will not be shared with other researchers.
Publications
McFadyen J, Habicht J, Dina LM, Harper R, Hauser TU, Rollwage M. Increasing engagement with cognitive-behavioral therapy (CBT) using generative AI: a randomized controlled trial (RCT). Commun Med (Lond). 2026 Jan 15;6(1):129. doi: 10.1038/s43856-025-01321-8.
PubMed 41540194
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Symptom Reduction: AI-Enabled App vs PDF Workbook
- ClinicalTrials.gov ID
- NCT06459128
- Acronym / sponsor ID
- LC-2024Q2-01
- Conditions
- Mental Health Issue
- Keywords
- ai, llm, cbt, cognitive behavioural therapy, cognitive behavioral therapy, artificial intelligence, large language model, app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Limbic LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do people using the app experience greater reductions in anxiety and depression symptoms compared to those using the workbook?
- 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
Motivation
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Enabled Mobile Application (Limbic Care) | Experimental | Device: Limbic CareParticipants 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. |
| Digital Workbook (PDF) | Active comparator | Device: Digital WorkbookParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Currently undergoing mental health therapy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limbic CareLimbic 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. | Device | AI-Enabled Mobile Application (Limbic Care) |
| Digital WorkbookThe 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). | Device | Digital Workbook (PDF) |
Primary outcome
Change in GAD-7 (Anxiety)
Time frame: Baseline to Week 6, and weekly (from Baseline to Week 6)
The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item self-report questionnaire used to screen for and measure the severity of generalized anxiety disorder (GAD).
Change in PHQ-9 (Depression)
Time frame: Baseline to Week 6, and weekly (from Baseline to Week 6)
The PHQ-9 (Patient Health Questionnaire-9) is a 9-item self-report screening and diagnostic tool for depression.
Therapy Completion
Time frame: Summed across Week 1 to Week 6
Proportion of therapy content viewed (exercises in-app, or PDF pages viewed)
Engagement Duration
Time frame: Summed across Week 1 to Week 6
Time spent in the Limbic Care application (intervention) or viewing workbook pages (control).
1 secondary outcome
Incidence of Adverse Health Events
Time frame: Summed across Week 1 to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41540194McFadyen J, Habicht J, Dina LM, Harper R, Hauser TU, Rollwage M. Increasing engagement with cognitive-behavioral therapy (CBT) using generative AI: a randomized controlled trial (RCT). Commun Med (Lond). 2026 Jan 15;6(1):129. doi: 10.1038/s43856-025-01321-8.
- Individual participant dataSharing planned: Undecided. IPD will not be shared with other researchers.
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Rollwage, PhD principal investigator
Limbic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limbic Care and Digital Workbook in people with Mental Health Issue, run by Limbic Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GAD-7 (Anxiety) (time frame: Baseline to Week 6, and weekly (from Baseline to Week 6)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06459128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.