Evaluate Treatment Outcomes For AI-Enabled Information Collection Tool For Clinical Assessments In Mental Healthcare

In the proposed study, the investigators aim to test an AI-prototype which adaptively collects information about a patient's mental health symptoms at the time of referral in order to support and facilitate the clinical assessment.

Study Overview

• Status: Recruiting
• Conditions: Mental Health Issue
• Intervention / Treatment: Diagnostic test: Standard Limbic Access pathway; Diagnostic test: Limbic Access with AI pathway

Detailed Description

In the proposed study, the investigators aim to test an AI-prototype which adaptively collects information about a patient's mental health symptoms at the time of referral in order to support and facilitate the clinical assessment.

The AI-system consists of a machine learning model which produces a probabilistic prediction about a patient's most likely presenting problems (ranking different diagnoses based on their probability) based on standard referral information collected through Limbic Access (e.g. free-text description of the patient's symptoms, GAD-7 & PHQ-9 etc). Based on the ML prediction, up to two additional anxiety disorder specific measures (ADSM) will be administered in order to collect additional insights about the specific mental health symptoms experienced by the patient (i.e. tailored to the specific patient). The collected ADSM scores will be attached to the final referral information in order to support and facilitate the clinical assessment and ultimately improve the diagnosis process while saving clinical time. For this trial, the AI-model will only function as a support tool for the clinical assessment by collecting additional data ahead of time.

Specifically, the investigators are interested in evaluating whether the AI supported information collection improves treatment outcomes, reliability of clinical assessment, reduces waiting and assessment times as well as reduces treatment drop out rates.

• Study Type: Interventional
• Enrollment (Anticipated): 5400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Max Rollwage; Email: max@limbic.ai

Study Locations

• United Kingdom
  • Gosforth, United Kingdom, NE13 9BA
    • Recruiting
    • Insight Healthcare
    • Contact: Mona Stylianou; Phone Number: 0300 029 3000; Email: mona.stylianou@InsightHealthcare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant meets minimum age requirements for the service
• Participant's registered GP is within the IAPT CCG catchment area

Exclusion Criteria:

• Participants who are in crisis (defined by requiring urgent care or being at an urgent risk of harm)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Limbic Access; In this arm, participants will refer through the standard pathway of Limbic Access. During this process patients provide the minimal required information (e.g. demographic information) as well as some basic information about their experienced mental health symptoms (e.g. PHQ-9 & GAD-7). This information is attached to the referral provided to the clinician before the clinical assessment.	Diagnostic test: Standard Limbic Access pathway; Relevant information for clinical referral (e.g. demographics) and basic clinical information (e.g. PHQ-9 & Gad-7 scores) are collected during the self-referral process which is then attached to the referral notes in order to facilitate the clinical assessment conducted by the clinician.
Experimental: Limbic Access with AI; In this arm, provide all information as in the standard Limbic Access pathway. Based on this information a machine-learning model is used to predict the most likely presenting problem, based on which up to two additional anxiety specific measures are administered in order to collect more tailored information about the patients' experienced mental health symptoms. All the information is attached to the referral provided to the clinician before the clinical assessment.	Diagnostic test: Limbic Access with AI pathway; The same information as in the Limbic Access pathway is collected. However, additional information (i.e. disorder specific questionnaires) are collected for the most likely problem descriptors based on the ML-model predictions. All information is attached to the referral in order to facilitate the clinical assessment conducted by the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline depression score to after treatment	The primary outcome will be defined as reliable and clinically significant improvement in clinical scores after treatment. Hereby, the investigators will test for changes in depression scores using Patient Health Questionnaire-9 (PHQ-9: posttreatment scores <10 and improved by ≥6 points). PHQ-9 includes 9 questions scored between 0 and 3, with higher scores indicating more severe depression.	The definition of reliable and clinically significant improvement is based on a comparison of pre-treatment (at time of referral, on the day of consenting) and post-treatment (assessed at point of discharge, an average of 5 months) clinical score.
Change from baseline anxiety score to after treatment	The primary outcome will be defined as reliable and clinically significant improvement in clinical scores after treatment. Hereby, we will test for changes in anxiety scores using Generalised Anxiety Disorder Assessment (GAD-7: posttreatment scores <8 and improved by ≥4 points).GAD-7 includes 7 questions scored between 0 and 3, with higher scores indicating more severe anxiety.	The definition of reliable and clinically significant improvement is based on a comparison of pre-treatment (at time of referral, on the day of consenting) and post-treatment (assessed at point of discharge, an average of 5 months) clinical score.
Change in diagnosis	Improved diagnosis will be measured as the correspondence between the diagnosis at the initial clinic assessment and the diagnosis at the end of treatment. During treatment in IAPT the diagnoses will be continuously assessed during the course of treatment in order to step the treatment up or down if needed. The agreement of diagnoses at these two time points will be coded as a binary variable ("agreement" versus "disagreement"). The investigators will measure the percentage of patients for which the diagnosis at clinical assessment corresponds to the diagnoses at the end of treatment as a measure for the reliability for the initial diagnosis	The agreement score will be based on a comparison of diagnosis at the initial assessment (before first treatment session) and the diagnoses at the end of treatment (assessed at point of discharge, an average of 5 months from referral).
Clinical assessment times	Improved clinical efficiency will be indicated by reduced assessment times, measured by the average time per clinical assessment (in minutes).	This measure will be available after the clinical assessment (up to average of 1 month from consenting).
Waiting times for assessment	Patient waiting times for assessment will be measured as the time between the date of self-referral and the date of the clinical assessment.	This measure will be available after the clinical assessment (up to average of 1 month from consenting).
Waiting times for treatment	Patient waiting times for treatment will be measured as the time between the date of assessment and the date of the first treatment session	This measure will be available after the start of treatment (up to average of 4 month from consenting).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral Dropout Rates	Patient referral dropout will be measured as any individual who consented to participate in the study, but did not complete all requested clinical information during the referral process.	During chatbot interaction (day 1)
Assessment Dropout Rates	Clinical assessment dropout will be measured as any cancellation or "Did Not Attend" event for patients who successfully had a clinical assessment slot (eg. time and date) organised. The treatment cohort (Limbic Access with AI pathway) will be evaluated against a cohort of patients going through limbic Access' standard pathway across the same services and over the same time window as the study will be used for comparison.	At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)
Treatment Dropout Rates	Treatment dropout will be measured using a "dropout" label which is added to a patient's file in the service's patient management system by the treating clinician when a dropout event occurs. The treatment cohort (Limbic Access +AI pathway) will be evaluated against a cohort of patients going through limbic Access' standard pathway across the same services and over the same time window as the study will be used for comparison.	At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement rate between the probabilistic model prediction (in the Limbic Access +AI pathway) and the clinical diagnosis.	Kappa for each diagnosis will be calculated as agreement score between the model prediction and the diagnosis at clinical assessment.	The diagnosis of the clinician will be assessed at time of the clinical assessment (assessed up to 1 month).
Bias in the predictive power of the model with regards to particular patient demographics	Percentage of agreement between model prediction and clinical diagnosis for different demographic groups	Demographic data is captured at the point of referral on the day that participants gives their consent.

Collaborators and Investigators

• Sponsor: Limbic Limited
• Collaborators: Insight Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): July 10, 2023
• Study Completion (Anticipated): April 10, 2024

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Limbic-303303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No