Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

Sponsor
Limbic Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05678764
Collaborator
(none)
300,000
34.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Conversational Information Collection Tool

Study Design

Study Type:
Observational
Anticipated Enrollment :
300000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of a Conversational Information Collection Tool to Access Talk Therapy
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline depression score to after treatment [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.]

    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.

  2. Change from baseline anxiety score to after treatment [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]

    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.

  3. Clinical assessment times [This measure will be available after the clinical assessment (up to average of 1 month from consenting).]

    Improved clinical efficiency will be indicated by reduced assessment times, measured by the average time per clinical assessment (in minutes).

Secondary Outcome Measures

  1. Waiting times [This measure will be available after the clinical assessment (up to average of 1 month from consenting).]

    Patient waiting times for treatment will be measured as the time between the date of (self-referral) and the date of the clinical assessment.

  2. Referral Dropout Rates [During Information Collection Tool interaction (day 1)]

    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.

  3. Assessment Dropout Rates [At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)]

    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.

  4. Treatment Dropout Rates [At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Limbic Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Limbic Limited
ClinicalTrials.gov Identifier:
NCT05678764
Other Study ID Numbers:
  • 112233
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 10, 2023