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Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05678764
Enrollment
104874
Registered
2023-01-10
Start date
2023-06-29
Completion date
2025-10-07
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue

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.

Interventions

DEVICEConversational Information Collection Tool

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

Sponsors

Limbic Limited
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline depression score to after treatmentThe 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.
Change from baseline anxiety score to after treatmentThe 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 scoreThe 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.
Clinical assessment timesThis 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

MeasureTime frameDescription
Waiting timesThis 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.
Treatment Dropout RatesAt 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.
Referral Dropout RatesDuring 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.
Assessment Dropout RatesAt 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026