Mental Health IssueNCT05678764
Evaluation of a Conversational Information Collection Tool to Access Talk Therapy
An observational study of Mental Health Issue, run by Limbic Limited at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Conversational Information Collection Tool
- Type of treatment
- Medical device
- How many people
- 104,874 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 29 Jun 2023to 7 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who refer to the talk therapy services that use the conversational information collection tool.
Who may be able to join
- Participant meets minimum age requirements for the talk therapy service Participant's registered GP is within the talk therapy service's CCG catchment area
Who cannot join
- Participants who are in crisis (defined by requiring urgent care or being at an urgent risk of harm)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Essex Partnership University NHS Foundation Trust
Epping
Surrey and Borders Partnership NHS Foundation Trust
Leatherhead, Surrey, KT22 9AD
Lincolnshire Partnership NHS Foundation Trust
Lincoln, LN1 1FS
About this study
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
- Being tested
- Conversational Information Collection Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational Information Collection ToolDevice
Conversational Information Collection Tool that facilitates the self-referral to talk therapy.
| Study group | Role | What they receive |
|---|---|---|
| Conversational Information Collection Tool Referrals | These are patients who refer to talk therapy using the novel information collection tool. Receives: Device: Conversational Information Collection Tool | |
| Other Referrals | These are patients who refer to talk therapy using other referral methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: This measure will be available after the clinical assessment (up to average of 1 month from consenting).
Secondary outcomes (4)
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.
Measured: This measure will be available after the clinical assessment (up to average of 1 month from consenting).
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.
Measured: During Information Collection Tool interaction (day 1)
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.
Measured: 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.
Measured: At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start29 Jun 2023
- Primary completion1 Jun 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104,874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limbic Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678764
- Sponsor's protocol ID
- 112233
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Fully anonymised data might be shared as part of the publication process.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Conversational Information Collection Tool to Access Talk Therapy
- ClinicalTrials.gov ID
- NCT05678764
- Acronym / sponsor ID
- 112233
- Conditions
- Mental Health Issue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104,874 participants (actual)
- Lead sponsor
- Limbic LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversational Information Collection Tool Referrals | – | Device: Conversational Information Collection ToolThese are patients who refer to talk therapy using the novel information collection tool. |
| Other Referrals | – | –These are patients who refer to talk therapy using other referral methods. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who refer to the talk therapy services that use the conversational information collection tool.
Key inclusion criteria (1 listed)
- Participant meets minimum age requirements for the talk therapy service Participant's registered GP is within the talk therapy service's CCG catchment area
Key exclusion criteria (1 listed)
- Participants who are in crisis (defined by requiring urgent care or being at an urgent risk of harm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversational Information Collection ToolConversational Information Collection Tool that facilitates the self-referral to talk therapy. | Device | Conversational Information Collection Tool Referrals |
Primary outcome
Change from baseline depression score to after treatment
Time frame: 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.
Change from baseline anxiety score to after treatment
Time frame: 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.
Clinical assessment times
Time frame: 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).
4 secondary outcomes
Waiting times
Time frame: This measure will be available after the clinical assessment (up to average of 1 month from consenting).
Referral Dropout Rates
Time frame: During Information Collection Tool interaction (day 1)
Assessment Dropout Rates
Time frame: At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)
Treatment Dropout Rates
Time frame: At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided. Fully anonymised data might be shared as part of the publication process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue, run by Limbic Limited at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depression score to after treatment (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.