Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

NCT05678764 | Completed

• 1 other identifier: 112233
• Study Type: observational
• Target: 104,874
• Locations: 1 country
• Sites: 3

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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (3)

• 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

• 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 Outcomes (4)

• Waiting times

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

• Referral Dropout Rates

  During Information Collection Tool interaction (day 1)

• Assessment Dropout Rates

  At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)

• Treatment Dropout Rates

  At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)

Study Arms (2)

Conversational Information Collection Tool Referrals

These are patients who refer to talk therapy using the novel information collection tool.

Device: Conversational Information Collection Tool

Other Referrals

These are patients who refer to talk therapy using other referral methods.

Interventions

Conversational Information Collection Tool DEVICE

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

Conversational Information Collection Tool Referrals

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Limbic Limited: lead

Study Sites (3)

Surrey and Borders Partnership NHS Foundation Trust

Leatherhead, Surrey, KT22 9AD, United Kingdom

Location

Essex Partnership University NHS Foundation Trust

Epping, United Kingdom

Location

Lincolnshire Partnership NHS Foundation Trust

Lincoln, LN1 1FS, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: June 29, 2023
• Primary Completion: June 1, 2025
• Study Completion: October 7, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

GB (3)