Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459128
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Brief Title:
Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Outcomes AI-Enabled App vs PDF Workbook
Sponsor:
Limbic Limited
Organization:
Limbic Limited
Study Overview
Official Title:
Comparison of Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Symptom Reduction AI-Enabled App vs PDF Workbook
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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:
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 andor depression The study will involve 500 participants who will be randomly allocated in a 32 ratio to either the intervention group Limbic Care app or the control group PDF workbook
A large cohort 2000 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 eg 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
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 andor depression The study will involve 500 participants who will be randomly allocated in a 32 ratio to either the intervention group Limbic Care app or the control group PDF workbook
A large cohort 2000 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None