Mental HealthNCT07470437
The Mouth Matters in Mental Health Trial -2
A study testing Link work intervention in people with Mental Health and Oral Health Care, run by Lancashire and South Cumbria NHS Foundation Trust at 5 sites in United Kingdom.
Trial summary
This clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Oral Health Care, Psychosis
- What is being tested?
- Link work intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 1 May 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years.
- Receipt of care from community mental health or early intervention teams at the point of referral.
- No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. Emergency dental care (e.g. emergency attendance at an Accident \& Emergency Appointment or a dental hospital) is not included within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
- Able to provide informed consent as determined by trained researchers in consultation with the clinical team.
Who cannot join
- Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community.
- Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and/or the referrer in approximately one-months' time to determine if risk has subsided to a point where they are now eligible.
- Enrolled in another dental randomised controlled trial.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
Pennine Care NHS Foundation Trust
Ashton-under-Lyne, OL67SR
Prof Berry, PhD, DClinPsy, +44161 716 3000, Katherine.Berry@manchester.ac.uk
- Not yet recruiting
South London and Maudsley NHS Foundation Trust
London, SE5 8AF
Dr Onwumere, ClinPsyD, +4420 3228 6000, juliana.1.onwumere@kcl.ac.uk
- Recruiting
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M253BL
Dr Griffiths, PhD, +44161 773 9121, Robert.Griffiths-2@manchester.ac.uk
- Recruiting
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, Northumberland, NE3 3XT
Dr Cochrane, ClinPsyD, +44191 246 6800, marsha.cochrane@cntw.nhs.uk
- Recruiting
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, PR2 8DW
Dr Palmier-Claus,, PhD, DClinPsy, +441772 773498, J.Palmier-Claus@lancaster.ac.uk
About this study
Official title: A Link Work Intervention to Support Dental Visiting in People With Severe Mental Health Difficulties: The Mouth Matters in Mental Health Effectiveness and Cost-Effectiveness Trial
This clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life.
The main predictions are that:
- The link work intervention plus treatment as usual will lead to greater likelihood of attendance at a routine dental appointment, compared with treatment as usual alone.
- The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone.
- The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.
Read the detailed description
Aim: To evaluate the effectiveness and cost-effectiveness of a link work intervention to facilitate dental attendance in people with severe mental illness.
Methods: An effectiveness randomised-controlled trial with integrated cost-effectiveness analysis and process evaluation. 480 participants will be recruited from five NHS Trusts and randomised (ratio 1:1) to either treatment as usual or treatment as usual plus the link work intervention. The link work intervention will follow the manual co-developed and used in the feasibility trial. Blind research assistants will support participants to complete assessments at baseline and after nine-months. The investigators will obtain consent to access participant's dental visiting data via the Business Services Authority. The primary outcomes are i) attendance at a routine dental appointment, and ii) oral health related quality of life. Health economics analysis will assess whether the intervention is cost-effective. A qualitative process evaluation will help to understand how it works and might be implemented.
Results/conclusions: This research hopes to produce the first evidenced-based intervention for improving the oral health of people with severe mental illness. It could help to overcome inequities in dental access.
- Conditions
- Mental Health, Oral Health Care, Psychosis
- Being tested
- Link work intervention
- Keywords
- Mouth Matters, Dentistry, mental health
- Medical subject headings
- Psychological Well-Being, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Link work interventionBehavioural
The mental health link work intervention uses link workers to empower and assist people with severe mental illness currently supported by secondary care mental health services, but not dental services, to access planned dental appointments. The link work intervention in the study proposal has the following dimensions:
- Delivered by mental health support workers.
- Focused on oral health as the primary health issue.
- Setting is in secondary mental health care linking to dental care
- Primary role is navigating or bridging services.
- It builds motivation where needed and offers advocacy.
- Its builds self-efficacy and recursively through social persuasion, positive reinforcement, and positive experiences of dental visits and interacting with dental services.
- Training and supervision to link workers supports intervention delivery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Treatment as usual will include any treatments or services that the participant would normally have access to outside of the trial. For people with severe mental illness this may include support from a care coordinator, support worker, psychologist, occupational therapist, and/or psychiatrist for care around their mental health. Treatment as usual may include medication and case management. The investigators will monitor, rather than withhold, assessment and treatment for oral health in the treatment as usual arm. |
| Treatment as usual plus a link work intervention | Experimental | Participants in this arm will receive treatment as usual plus the link work intervention. This will consist of six sessions with a link worker over nine-months who will offer practical and emotional support around accessing a routine dental appointment. Receives: Behavioral: Link work intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at a planned care appointments
As measured by the National Health Services Business Services Authority (NHS BSA).
Measured: From baseline to nine-month follow-up assessment.
Oral health related quality of life
Oral Health Impact Profile - 14 item version (OHIP-14), range: 0-56, higher scores indicate worse oral health related quality of life
Measured: From baseline to nine-month follow-up assessment .
Secondary outcomes (14)
Self-reported attendance at a planned dental appointment.
Self-report dental attendance items.
Measured: From baseline to nine-month follow-up assessment.
Orofacial pain & disability
Manchester Orofacial Pain Disability Scale. Two binary outcomes plus scale. Range: 0-52. Higher scores indicates greater pain (binary) / help seeking (binary) / pain related disability (scale).
Measured: From baseline to nine-month follow-up assessment
Confidence around dental visiting
Single item of self-efficacy around attendance. Range 1-7. A higher score indicates greater confidence around dental visiting.
Measured: From baseline to nine-month follow-up assessment.
Self-esteem
Rosenberg Self-Esteem Scale. Range: 0-30. A higher score indicates better self-esteem.
Measured: From baseline to nine-month follow-up assessment
Dental anxiety
Modified Dental Anxiety Scale. Range: 5-25. A higher score indicates greater levels of dental anxiety.
Measured: From baseline to nine-month follow-up assessment.
General anxiety
Generalised Anxiety Disorder Questionnaire. Range: 0-21. A higher score indicates greater levels of anxiety.
Measured: From baseline to nine-month follow-up assessment .
Depression
Patient Health Questionnaire - 9 items. Range 0-27. A higher score indicates greater levels of depression.
Measured: From baseline to nine-month follow-up assessment.
The number of planned dental appointments attended
Recorded via the National Health Service Business Services Authority.
Measured: From baseline to nine-month follow-up assessment.
Self-reported access to free/subsidised dental care.
Self-report items
Measured: From baseline to nine-month follow-up assessment.
Exemption status for dental care
As recorded by the National Health Service Business Services Authority
Measured: From baseline to nine-month follow-up assessment.
Completion of a course of dental treatment
As record via the National Health Service Business Services Authority.
Measured: From baseline to nine-month follow-up assessment.
Self-reported utilisation of urgent or emergency dental services.
Self-report items
Measured: From baseline to nine-month follow-up assessment.
Quality adjusted life years
European Quality of Life five-dimensional questionnaire (EQ-5D-5L). Five health dimensions plus overall health score on a visual analogue scale range. Range on visual analogue scale: 0-100. A higher score indicates better health.
Measured: From baseline to nine-month follow-up assessment.
Utilization of healthcare resources
Co-designed health economics questionnaire recording utilisation of services and treatment.
Measured: From baseline to nine-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 May 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The link work intervention consists of six-sessions with a trained link worker over nine-months. The link worker will provide emotional and practical support to support the person to access a routine dental appointment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancashire and South Cumbria NHS Foundation Trust
- Sponsor type
- Research network
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust, Pennine Care NHS Foundation Trust, Northumberland, Tyne and Wear NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Lancaster University, University of Liverpool, University of Leeds, University of Manchester, King's College London
- Responsible party
- Principal investigator, Jasper Palmier-Claus, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470437
- Sponsor's protocol ID
- NIHR171340
- Other IDs
- 350197
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the trial results, the investigators will make suitable arrangements for anonymised data to be available from the research team, in line with NIHR data sharing guidance. This will be outlined in the Data Access Management Plan (DAMP) developed in the early phases of the project.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Link Work Intervention to Support Dental Visiting in People With Severe Mental Health Difficulties: The Mouth Matters in Mental Health Effectiveness and Cost-Effectiveness Trial
- ClinicalTrials.gov ID
- NCT07470437
- Acronym / sponsor ID
- NIHR171340
- Conditions
- Mental Health, Oral Health Care, Psychosis
- Keywords
- Mouth Matters, Dentistry, mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Lancashire and South Cumbria NHS Foundation TrustResearch network
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust, Pennine Care NHS Foundation Trust, Northumberland, Tyne and Wear NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Lancaster University, University of Liverpool, University of Leeds, University of Manchester, King's College London
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 13 Mar 2026 (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 clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life.
The main predictions are that:
- The link work intervention plus treatment as usual will lead to greater likelihood of attendance at a routine dental appointment, compared with treatment as usual alone.
- The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone.
- The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.
Detailed description
Aim: To evaluate the effectiveness and cost-effectiveness of a link work intervention to facilitate dental attendance in people with severe mental illness.
Methods: An effectiveness randomised-controlled trial with integrated cost-effectiveness analysis and process evaluation. 480 participants will be recruited from five NHS Trusts and randomised (ratio 1:1) to either treatment as usual or treatment as usual plus the link work intervention. The link work intervention will follow the manual co-developed and used in the feasibility trial. Blind research assistants will support participants to complete assessments at baseline and after nine-months. The investigators will obtain consent to access participant's dental visiting data via the Business Services Authority. The primary outcomes are i) attendance at a routine dental appointment, and ii) oral health related quality of life. Health economics analysis will assess whether the intervention is cost-effective. A qualitative process evaluation will help to understand how it works and might be implemented.
Results/conclusions: This research hopes to produce the first evidenced-based intervention for improving the oral health of people with severe mental illness. It could help to overcome inequities in dental access.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The link work intervention consists of six-sessions with a trained link worker over nine-months. The link worker will provide emotional and practical support to support the person to access a routine dental appointment.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Treatment as usual will include any treatments or services that the participant would normally have access to outside of the trial. For people with severe mental illness this may include support from a care coordinator, support worker, psychologist, occupational therapist, and/or psychiatrist for care around their mental health. Treatment as usual may include medication and case management. The investigators will monitor, rather than withhold, assessment and treatment for oral health in the treatment as usual arm. |
| Treatment as usual plus a link work intervention | Experimental | Behavioral: Link work interventionParticipants in this arm will receive treatment as usual plus the link work intervention. This will consist of six sessions with a link worker over nine-months who will offer practical and emotional support around accessing a routine dental appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years.
- Receipt of care from community mental health or early intervention teams at the point of referral.
- No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. Emergency dental care (e.g. emergency attendance at an Accident \& Emergency Appointment or a dental hospital) is not included within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
- Able to provide informed consent as determined by trained researchers in consultation with the clinical team.
Key exclusion criteria (3 listed)
- Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community.
- Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and/or the referrer in approximately one-months' time to determine if risk has subsided to a point where they are now eligible.
- Enrolled in another dental randomised controlled trial.
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 |
|---|---|---|
| Link work interventionThe mental health link work intervention uses link workers to empower and assist people with severe mental illness currently supported by secondary care mental health services, but not dental services, to access planned dental appointments. The link work intervention in the study proposal has the following dimensions: * Delivered by mental health support workers. * Focused on oral health as the primary health issue. * Setting is in secondary mental health care linking to dental care * Primary role is navigating or bridging services. * It builds motivation where needed and offers advocacy. * Its builds self-efficacy and recursively through social persuasion, positive reinforcement, and positive experiences of dental visits and interacting with dental services. * Training and supervision to link workers supports intervention delivery. | Behavioural | Treatment as usual plus a link work intervention |
Primary outcome
Attendance at a planned care appointments
Time frame: From baseline to nine-month follow-up assessment.
As measured by the National Health Services Business Services Authority (NHS BSA).
Oral health related quality of life
Time frame: From baseline to nine-month follow-up assessment .
Oral Health Impact Profile - 14 item version (OHIP-14), range: 0-56, higher scores indicate worse oral health related quality of life
14 secondary outcomes
Self-reported attendance at a planned dental appointment.
Time frame: From baseline to nine-month follow-up assessment.
Orofacial pain & disability
Time frame: From baseline to nine-month follow-up assessment
Confidence around dental visiting
Time frame: From baseline to nine-month follow-up assessment.
Self-esteem
Time frame: From baseline to nine-month follow-up assessment
Dental anxiety
Time frame: From baseline to nine-month follow-up assessment.
General anxiety
Time frame: From baseline to nine-month follow-up assessment .
Depression
Time frame: From baseline to nine-month follow-up assessment.
The number of planned dental appointments attended
Time frame: From baseline to nine-month follow-up assessment.
Self-reported access to free/subsidised dental care.
Time frame: From baseline to nine-month follow-up assessment.
Exemption status for dental care
Time frame: From baseline to nine-month follow-up assessment.
Completion of a course of dental treatment
Time frame: From baseline to nine-month follow-up assessment.
Self-reported utilisation of urgent or emergency dental services.
Time frame: From baseline to nine-month follow-up assessment.
Quality adjusted life years
Time frame: From baseline to nine-month follow-up assessment.
Utilization of healthcare resources
Time frame: From baseline to nine-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. Following publication of the trial results, the investigators will make suitable arrangements for anonymised data to be available from the research team, in line with NIHR data sharing guidance. This will be outlined in the Data Access Management Plan (DAMP) developed in the early phases of the project.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Link work intervention in people with Mental Health and Oral Health Care, run by Lancashire and South Cumbria NHS Foundation Trust at 5 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Palmier-Claus, PhD, DClinPsy (+44 1772 773500, J.Palmier-Claus@lancaster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at a planned care appointments (time frame: From baseline to nine-month follow-up assessment.). The study lists 2 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 27 Jul 2026.