Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Device: Conversational Information Collection Tool

• Study Type: Observational
• Enrollment (Actual): 104874

Contacts and Locations

Study Locations

• United Kingdom
  • Epping, United Kingdom
    • Essex Partnership University NHS Foundation Trust
  • Lincoln, United Kingdom, LN1 1FS
    • Lincolnshire Partnership NHS Foundation Trust
  • Surrey
    • Leatherhead, Surrey, United Kingdom, KT22 9AD
      • Surrey and Borders Partnership NHS Foundation Trust

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients who refer to the talk therapy services that use the conversational information collection tool.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conversational Information Collection Tool Referrals; These are patients who refer to talk therapy using the novel information collection tool.	Device: Conversational Information Collection Tool; Conversational Information Collection Tool that facilitates the self-referral to talk therapy.
Other Referrals; These are patients who refer to talk therapy using other referral methods.

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.
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).
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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)
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)

Collaborators and Investigators

• Sponsor: Limbic Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): October 7, 2025

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 112233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Fully anonymised data might be shared as part of the publication process.

Drug and device information, study documents

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