Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Outcomes: AI-Enabled App vs PDF Workbook

NCT06459128 | Completed

• 1 other identifier: LC-2024Q2-01
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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. 1.Do people using the app experience greater reductions in anxiety and depression symptoms compared to those using the workbook?
2. 2.Does the personalization offered by the app increase engagement with CBT materials compared to the workbook?

Conditions

Mental Health Issue

Keywords

ai; llm; cbt; cognitive behavioural therapy; cognitive behavioral therapy; artificial intelligence; large language model; app; cbt-i; homework; limbic; worksheets; workbook; cbt intervention

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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)

  Summed across Week 1 to Week 6

• Engagement Duration

  Time spent in the Limbic Care application (intervention) or viewing workbook pages (control).

  Summed across Week 1 to Week 6

Secondary Outcomes (1)

• Incidence of Adverse Health Events

  Summed across Week 1 to Week 6

Other Outcomes (5)

• Change in WSAS (Wellbeing)

  Baseline to Week 6, and weekly (from Baseline to Week 6)

• Satisfaction and Acceptability

  Weekly, from Week 1 to Week 6

• Utility and Effectiveness

  Weekly, from Week 1 to Week 6

Study Arms (2)

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.

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.

Device: Digital Workbook

Interventions

Limbic Care DEVICE

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.

AI-Enabled Mobile Application (Limbic Care)

Digital Workbook DEVICE

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).

Digital Workbook (PDF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limbic Limited: lead

Study Sites (1)

Limbic Limited

London, Greater London, EC1V 2NX, United Kingdom

Location

Related Publications (1)

• 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. doi: 10.1038/s43856-025-01321-8. Online ahead of print.

  PMID: 41540194 DERIVED

MeSH Terms

Conditions

Color Vision Defects; Alzheimer Disease

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Max Rollwage, PhD

  Limbic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: June 5, 2024
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

GB (1)