Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

Mental Health Issue Clinical Trial

Official title:

Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678764
• Other study ID #: 112233
• Status: Recruiting
• Start date: June 29, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Limbic Limited
• Contact: Johanna Habicht
• Phone: 07444518579
• Email: johanna[@]limbic.ai
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study evaluating a conversational information collection tool to access talk therapy. The patient outcome data will be compared between people who refer to talk therapy via the conversational information collection tool and people who refer using other means.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300000
• Est. completion date: December 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Device:
• Conversational Information Collection Tool
Conversational Information Collection Tool that facilitates the self-referral to talk therapy.

Locations

Country	Name	City	State
United Kingdom	Essex Partnership University NHS Foundation Trust	Epping

Sponsors (1)

Lead Sponsor	Collaborator
Limbic Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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).
Secondary	Waiting times	Patient waiting times for treatment 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).
Secondary	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 Information Collection Tool interaction (day 1)
Secondary	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)
Secondary	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)