Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Outcomes: AI-Enabled App vs PDF Workbook
NCT Number: NCT06459128
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue
Interventions: DEVICE: Limbic Care|DEVICE: Digital Workbook
Sponsor: Limbic Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-21
Completion Date: 2024-07-17
Locations: Limbic Limited, London, Greater London, EC1V 2NX, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Incidence of Adverse Health Events, Self-reported incidence of any adverse health events (physical or mental) experienced in the past week., Summed across Week 1 to Week 6
Other Outcome Measures: Change in WSAS (Wellbeing), The Work and Social Adjustment Scale (WSAS) is a 5-item self-report measure used to assess the degree of functional impairment attributable to an identified problem or disorder (for this study, participants were asked to consider their problems more generally)., Baseline to Week 6, and weekly (from Baseline to Week 6)|Satisfaction and Acceptability, Self-report ratings on custom Likert scales for perceived usability, satisfaction, and acceptability of the assigned materials, Weekly, from Week 1 to Week 6|Utility and Effectiveness, Self-report ratings on custom Likert scales for the perceived usefulness, comprehension, personalization, and sense of accomplishment related to the assigned materials, Weekly, from Week 1 to Week 6|Motivation, Self-report ratings on custom Likert scales for how motivated participants were to engage with the assigned materials, how much they would recommend the materials, and their reported engagement with the materials., Weekly, from Week 1 to Week 6|Change in MSQ (Sleep), The Mini Sleep Questionnaire (MSQ) is a 10-question self-report instrument designed to screen for excessive daytime sleepiness (EDS) and sleep disorders., Baseline to Week 6, and weekly (from Baseline to Week 6)