Mental Disorders, SevereNCT05545228
The Mouth Matters in Mental Health Study
A study testing Link work intervention in people with Mental Disorders, Severe, run by Lancaster University at 5 sites in United Kingdom.
Trial summary
To investigate the feasibility and acceptability of a link work intervention to increase planned dental care visits for patients with severe mental illness, and through this to improve their oral health. 1. To understand what constitutes best practice when delivering link work around dental visiting. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- Link work intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 1 Sep 2022to Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged >18 years
- Able to provide informed consent
- Receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention Team at the point of referral
- No routine and planned dental appointment in the past 3 years. The person should not have accessed a dental service (e.g. high street dentist, special care dentist service) for routine or planned dental care in the past 3 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. The researchers do not consider emergency dental care (e.g. attendance at A\&E, dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
Who cannot join
- Inpatient status on a psychiatric or secure ward. The researchers will allow participants in supported living to take part as long as they are in receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention for Psychosis Service
- 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). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and the referrer in approximately 1 month's time (or a time period agreed in collaboration with the individual) to determine if the risk has subsided to a point where they are now eligible.
- Enrolled in a dental trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Pennine Care NHS Foundation Trust
Ashton-under-Lyne, Great Manchester, OL6 7SR
Lancaster University
Lancaster, Lancashire, LA1 4YW
Greater Manchester Mental Health NHS Foundation Trust
Manchester, Great Manchester, M25 3BL
University of Manchester
Manchester, Greater Manchester, M13 9PL
Lancashire and South Cumbria NHS Foundation Trust
Preston, Lancashire, PR2 8DW
About this study
Official title: A Randomised Feasibility Trial of an Intervention Using Mental Health Support Workers as Link Workers to Improve Dental Visiting in People With Severe Mental Illness: The Mouth in Mind Study
To investigate the feasibility and acceptability of a link work intervention to increase planned dental care visits for patients with severe mental illness, and through this to improve their oral health.
- To understand what constitutes best practice when delivering link work around dental visiting.
- To identify what training needs exist for support workers around link work.
- To determine whether patients with SMI are willing to be randomised to a trial targeting dental visiting.
- To understand whether it is feasible to collect clinical outcome and planned dental appointment data in this population.
- To explore if, and how, patients with severe mental illness engage with a link work intervention.
- To understand the potential factors impacting (e.g. facilitators and barriers) acceptability and delivery.
Read the detailed description
Background and study aims
Severe mental ill health (SMI) affects around 1% of the population. It includes depression, psychosis, and bipolar disorder. People with experience of SMI are more likely to have problems with their teeth and gums. This includes more missing, filled, and decayed teeth than people without SMI. Having poor oral health can impact a lot of everyday activities like eating, speaking and smiling. It can affect how patients see themselves and their mental health.
Dentists can treat many early teeth and gum problems. However, very few people with SMI attend regular dental appointments. Instead, they are more likely to seek help when in crisis and invasive treatments are the only option. Accessing a dentist for people with SMI can be difficult for lots of reasons. People can feel helpless, fearful, or unmotivated to attend. They can have difficulty booking, planning, and getting to appointments. They may struggle to pay for or access free dental care. Unfortunately, existing dental initiatives have not addressed the barriers facing this group. They do not help people with SMI to attend the dentist.
The investigators want to help people with SMI to access dental care. The study will use mental health support workers who are already working in the National Health Service (NHS). They will link people receiving care from mental health teams with dental services. The support workers will help people to book, plan, and attend regular dental appointments. They will support patients to apply for financial support. People call this type of support link work. Research has indicated that link work can increase dental visits in people who might not normally attend. Mental health support workers already do link work for other appointments. Link work has been used to help other vulnerable groups of people (e.g. children) around dental care. However, this will be the first use of link work to help people with SMI to attend the dentist.
Who can participate?
People with a severe mental health difficulties currently accessing secondary care mental health services at the point of referral (e.g. community mental health team, early intervention for psychosis service), but who have not had a routine dental appointment in the past three years.
What does the study involve?
Participants will be randomly allocated to receiving treatment as usual or treatment as usual plus the link work intervention. This will be decided by chance. The investigators will measure how often people in both groups visit the dentist. They will also assess the state of their teeth and gums. They will collect this data when people come into the study and after nine months. The authors will offer interviews to patients and staff involved in the trial to understand how they found their involvement.
What are the possible benefits and risks of participating?
The intervention aims to support people to access dental services. However, it is currently untested, which is the reason for doing the research.
When is the study starting and how long it is expected to run for?
Recruitment for the trial is starting in September 2022 and will run for seven months. The whole project is scheduled to finish in April 2024.
Who is funding the study?
The National Institute of Health Research (NIHR) Health and Social Care Delivery Research (HS\&DR) scheme are funding the project.
- Conditions
- Mental Disorders, Severe
- Being tested
- Link work intervention
- Keywords
- Mental Health, Oral Health, Dentistry
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Link work interventionBehavioural
Intervention from a link worker to support participants to access dental services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive treatment as usual plus a link work intervention to support access to dental services. Receives: Behavioral: Link work intervention |
| Treatment as usual group | No intervention | Participants to receive treatment as usual and will not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates - feasibility criteria
Data on ability to recruit randomise 84 participants to target in a 7-month recruitment window. Green ≥80%. Amber 60-79%. Red ≤59%.
Measured: 7 months
Visiting data - feasibility criteria
Percentage of participants with available data on dental visiting via self-report or BSA data. Green ≥90%. Amber 60-89%. Red ≤59%.
Measured: 9 months
Clinical exam - feasibility criteria
Percentage of participants completing the dental examination. Green ≥80%. Amber 60-79%. Red: ≤59%.
Measured: 9 months
Adherence to intervention - feasibility criteria
Percentage of participants receiving intervention ≥1 sessions during nine month window. Green ≥80%. Amber 60-79%. Red ≤59%.
Measured: 9 months
Intervention and trial protocol - feasibility criteria
Qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery. This will be via qualitative interviews with service users (participants), research staff (link workers, research assistants), and key stakeholders (referrers, managers, commissioners). Audio recordings of sessions and field notes will also be analysed.
Measured: 9 months
Safety of intervention - feasibility criteria
Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms. The authors will discontinue the trial if the intervention or procedures elevate risk.
Measured: 9 Months
Secondary outcomes (16)
Brief Pain Inventory - short form
A questionnaire to assess orofacial pain.
Measured: Baseline and 9 month assessments
Manchester Orofacial Pain Disability Scale
Pain related disability
Measured: Baseline and 9 month assessments
Oral Health Impact Profile
Oral health related quality of life
Measured: Baseline and 9 month assessments
Confidence around dental visiting
Item asking about confidence in visiting the dentist. "How confident are you that you will be able to attend a dental appointment?" (1, no confident; 7, very confident)
Measured: Baseline and 9 month assessments
Rosenberg Self-esteem Scale (RSES)
Assessing self-esteem
Measured: Baseline and 9 month assessments
Modified Dental Anxiety Scale
Assessing dental anxiety
Measured: Baseline and 9 month assessments
Patient Health Questionnaire (PHQ)
Assessing depression
Measured: Baseline and 9 month assessments
EuroQol 5 Dimension (EQ-5D-5L)
Assessing quality of life
Measured: Baseline and 9 month assessments
The number of eligible participants able to access free or subsidised dental care
Assessing ability to successfully access free or subsidised dental care collected via the business services authority and self-report.
Measured: Baseline and 9 month assessments
The number of planned dental appointments attended
The research team will record and report the number of routine dental appointments attended, recorded by both the business services authority and self-report.
Measured: Baseline and 9 month assessments
Oral health self-management - tooth brushing, mouth wash, and flossing
'How often do you brush your teeth nowadays?' (ordinal five-point scale); 'How long do you brush your teeth for nowadays?' (ordinal five-point scale); 'How often do you clean between your teeth (inter-dental cleaning with floss, inter-dental brushes, tooth picks)?' (ordinal five-point scale); and 'Do you use a fluoride mouth-wash?' (binary)
Measured: Baseline and 9 month assessments
Self reported attendance at a planned dental appointment
The research team will ask people the following 'Have you attended a dental service since the baseline assessment (nine months ago)? This would include a routine appointment with a dentist or special care dentistry service. It could also include a planned appointment at a dental hospital. However, it would not include an emergency dental appointment.'. Participants will also be asked to provide the dates and times of dental appointments. This outcome will be coded as whether the person has or has not accessed a planned dental appointment via self-report.
Measured: 9 months
Business services authority recorded attendance at a planned dental appointment
NHS England collects information on visiting behaviour via the Business Services Authority. The research team will gain participants consent to extract this data, which the researchers will then match to the participants research data. The business services authority will be used to collect data on whether a planned care appointment has taken place. This data will only pick up National Health Service, and not private, dental appointments. This outcome will be coded as whether the person has or has not accessed a planned dental appointment via the business services authority data.
Measured: 9 months
Number of decayed, missing, or filled teeth (DMFT) via dental examination
An examination for dental caries in permanent teeth will involve examining 32 teeth (i.e. all permanent teeth including wisdom teeth) with a metallic periodontal probe (Community Periodontal Index (CPI) probe) and a plane mouth mirror.
Measured: Baseline and 9 months
Pulpal involvement, ulceration due to trauma, fistula, and abscess (PUFA) via dental examination
The PUFA score per person is calculated in the same cumulative way as for the DMFT and represents the number of teeth that meet the PUFA diagnostic criteria. Thus, for an adult in our study the score can range from 0 to 32 PUFA.
Measured: Baseline and 9 months
Modified Plaque Score via dental examination
The locally derived system involves assessing six teeth representative of the entire dentition, for the worst plaque score on each tooth surface from visual examination and, where necessary, the use of a probe to detect the presence of plaque. These six teeth are the UL4 UL1 UR6 LL6 LR1 LR4. Each surface; Interproximal, buccal and lingual or palatal of the six teeth should be viewed in turn and the highest level of visible plaque on each surface should be scored '2'.
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2024
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Disorders, SevereStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A feasibility single-blinded randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper Palmier-Claus, Lancaster University
- Investigators
- Jasper Palmier-Claus, PhD, DClinPsy, Principal investigator, Lancaster UniversityRebecca Harris, BDS, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545228
- Sponsor's protocol ID
- IRAS304696
- Other IDs
- NIHR132853
- Status last verified
- May 2024
- First submitted
- 8 Sep 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palmier-Claus J, Morris A, French P, Griffiths R, Aggarwal VR, Berry K, Gkioni E, Harris R, Laverty L, Lobban F, Procter S, Kerry E, Newens C, Mupinga P, Golby R, Valemis K, Oakes L, Fazekas F, Perry A, Shiers D, Lodge C, Hilton C, Dawber A, Elliott E, Lunat F, Burnside G. A Link Work Intervention to Facilitate Dental Visiting in People With Severe Mental Illness: A Two-Arm, Multi-Site, Assessor Blind, Randomised Feasibility Trial With Dental Record Linkage. Community Dent Oral Epidemiol. 2025 Oct;53(5):580-586. doi: 10.1111/cdoe.70002. Epub 2025 Aug 4.
PubMed 40755121Hilton C, Morris A, Burnside G, Harris R, Aggarwal VR, Procter S, Griffiths R, French P, Laverty L, Lobban F, Berry K, Shiers D, Golby R, Fazekas F, Valemis K, Perry A, Newens C, Kerry E, Mupinga P, Gkioni E, Lodge C, Dawber A, Elliott E, Lunat F, Palmier-Claus J. A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper. Pilot Feasibility Stud. 2023 Sep 8;9(1):157. doi: 10.1186/s40814-023-01383-2.
PubMed 37684682
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Trial of an Intervention Using Mental Health Support Workers as Link Workers to Improve Dental Visiting in People With Severe Mental Illness: The Mouth in Mind Study
- ClinicalTrials.gov ID
- NCT05545228
- Acronym / sponsor ID
- IRAS304696
- Conditions
- Mental Disorders, Severe
- Keywords
- Mental Health, Oral Health, Dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 19 Sep 2022 (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.
To investigate the feasibility and acceptability of a link work intervention to increase planned dental care visits for patients with severe mental illness, and through this to improve their oral health.
- To understand what constitutes best practice when delivering link work around dental visiting.
- To identify what training needs exist for support workers around link work.
- To determine whether patients with SMI are willing to be randomised to a trial targeting dental visiting.
- To understand whether it is feasible to collect clinical outcome and planned dental appointment data in this population.
- To explore if, and how, patients with severe mental illness engage with a link work intervention.
- To understand the potential factors impacting (e.g. facilitators and barriers) acceptability and delivery.
Detailed description
Background and study aims
Severe mental ill health (SMI) affects around 1% of the population. It includes depression, psychosis, and bipolar disorder. People with experience of SMI are more likely to have problems with their teeth and gums. This includes more missing, filled, and decayed teeth than people without SMI. Having poor oral health can impact a lot of everyday activities like eating, speaking and smiling. It can affect how patients see themselves and their mental health.
Dentists can treat many early teeth and gum problems. However, very few people with SMI attend regular dental appointments. Instead, they are more likely to seek help when in crisis and invasive treatments are the only option. Accessing a dentist for people with SMI can be difficult for lots of reasons. People can feel helpless, fearful, or unmotivated to attend. They can have difficulty booking, planning, and getting to appointments. They may struggle to pay for or access free dental care. Unfortunately, existing dental initiatives have not addressed the barriers facing this group. They do not help people with SMI to attend the dentist.
The investigators want to help people with SMI to access dental care. The study will use mental health support workers who are already working in the National Health Service (NHS). They will link people receiving care from mental health teams with dental services. The support workers will help people to book, plan, and attend regular dental appointments. They will support patients to apply for financial support. People call this type of support link work. Research has indicated that link work can increase dental visits in people who might not normally attend. Mental health support workers already do link work for other appointments. Link work has been used to help other vulnerable groups of people (e.g. children) around dental care. However, this will be the first use of link work to help people with SMI to attend the dentist.
Who can participate?
People with a severe mental health difficulties currently accessing secondary care mental health services at the point of referral (e.g. community mental health team, early intervention for psychosis service), but who have not had a routine dental appointment in the past three years.
What does the study involve?
Participants will be randomly allocated to receiving treatment as usual or treatment as usual plus the link work intervention. This will be decided by chance. The investigators will measure how often people in both groups visit the dentist. They will also assess the state of their teeth and gums. They will collect this data when people come into the study and after nine months. The authors will offer interviews to patients and staff involved in the trial to understand how they found their involvement.
What are the possible benefits and risks of participating?
The intervention aims to support people to access dental services. However, it is currently untested, which is the reason for doing the research.
When is the study starting and how long it is expected to run for?
Recruitment for the trial is starting in September 2022 and will run for seven months. The whole project is scheduled to finish in April 2024.
Who is funding the study?
The National Institute of Health Research (NIHR) Health and Social Care Delivery Research (HS\&DR) scheme are funding the project.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A feasibility single-blinded randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Link work interventionParticipants will receive treatment as usual plus a link work intervention to support access to dental services. |
| Treatment as usual group | No intervention | –Participants to receive treatment as usual and will not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >18 years
- Able to provide informed consent
- Receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention Team at the point of referral
- No routine and planned dental appointment in the past 3 years. The person should not have accessed a dental service (e.g. high street dentist, special care dentist service) for routine or planned dental care in the past 3 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. The researchers do not consider emergency dental care (e.g. attendance at A\&E, dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
Key exclusion criteria (3 listed)
- Inpatient status on a psychiatric or secure ward. The researchers will allow participants in supported living to take part as long as they are in receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention for Psychosis Service
- 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). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and the referrer in approximately 1 month's time (or a time period agreed in collaboration with the individual) to determine if the risk has subsided to a point where they are now eligible.
- Enrolled in a dental 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 interventionIntervention from a link worker to support participants to access dental services. | Behavioural | Intervention group |
Primary outcome
Recruitment rates - feasibility criteria
Time frame: 7 months
Data on ability to recruit randomise 84 participants to target in a 7-month recruitment window. Green ≥80%. Amber 60-79%. Red ≤59%.
Visiting data - feasibility criteria
Time frame: 9 months
Percentage of participants with available data on dental visiting via self-report or BSA data. Green ≥90%. Amber 60-89%. Red ≤59%.
Clinical exam - feasibility criteria
Time frame: 9 months
Percentage of participants completing the dental examination. Green ≥80%. Amber 60-79%. Red: ≤59%.
Adherence to intervention - feasibility criteria
Time frame: 9 months
Percentage of participants receiving intervention ≥1 sessions during nine month window. Green ≥80%. Amber 60-79%. Red ≤59%.
Intervention and trial protocol - feasibility criteria
Time frame: 9 months
Qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery. This will be via qualitative interviews with service users (participants), research staff (link workers, research assistants), and key stakeholders (referrers, managers, commissioners). Audio recordings of sessions and field notes will also be analysed.
Safety of intervention - feasibility criteria
Time frame: 9 Months
Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms. The authors will discontinue the trial if the intervention or procedures elevate risk.
16 secondary outcomes
Brief Pain Inventory - short form
Time frame: Baseline and 9 month assessments
Manchester Orofacial Pain Disability Scale
Time frame: Baseline and 9 month assessments
Oral Health Impact Profile
Time frame: Baseline and 9 month assessments
Confidence around dental visiting
Time frame: Baseline and 9 month assessments
Rosenberg Self-esteem Scale (RSES)
Time frame: Baseline and 9 month assessments
Modified Dental Anxiety Scale
Time frame: Baseline and 9 month assessments
Patient Health Questionnaire (PHQ)
Time frame: Baseline and 9 month assessments
EuroQol 5 Dimension (EQ-5D-5L)
Time frame: Baseline and 9 month assessments
The number of eligible participants able to access free or subsidised dental care
Time frame: Baseline and 9 month assessments
The number of planned dental appointments attended
Time frame: Baseline and 9 month assessments
Oral health self-management - tooth brushing, mouth wash, and flossing
Time frame: Baseline and 9 month assessments
Self reported attendance at a planned dental appointment
Time frame: 9 months
Business services authority recorded attendance at a planned dental appointment
Time frame: 9 months
Number of decayed, missing, or filled teeth (DMFT) via dental examination
Time frame: Baseline and 9 months
Pulpal involvement, ulceration due to trauma, fistula, and abscess (PUFA) via dental examination
Time frame: Baseline and 9 months
Modified Plaque Score via dental examination
Time frame: Baseline and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 40755121Palmier-Claus J, Morris A, French P, Griffiths R, Aggarwal VR, Berry K, Gkioni E, Harris R, Laverty L, Lobban F, Procter S, Kerry E, Newens C, Mupinga P, Golby R, Valemis K, Oakes L, Fazekas F, Perry A, Shiers D, Lodge C, Hilton C, Dawber A, Elliott E, Lunat F, Burnside G. A Link Work Intervention to Facilitate Dental Visiting in People With Severe Mental Illness: A Two-Arm, Multi-Site, Assessor Blind, Randomised Feasibility Trial With Dental Record Linkage. Community Dent Oral Epidemiol. 2025 Oct;53(5):580-586. doi: 10.1111/cdoe.70002. Epub 2025 Aug 4.
- Derived from this study: PubMed 37684682Hilton C, Morris A, Burnside G, Harris R, Aggarwal VR, Procter S, Griffiths R, French P, Laverty L, Lobban F, Berry K, Shiers D, Golby R, Fazekas F, Valemis K, Perry A, Newens C, Kerry E, Mupinga P, Gkioni E, Lodge C, Dawber A, Elliott E, Lunat F, Palmier-Claus J. A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper. Pilot Feasibility Stud. 2023 Sep 8;9(1):157. doi: 10.1186/s40814-023-01383-2.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mental Disorders, Severe
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
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.
Jasper Palmier-Claus, PhD, DClinPsy principal investigator
Lancaster University
Rebecca Harris, BDS, PhD principal investigator
University of Liverpool
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 Disorders, Severe, run by Lancaster University 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
Results are not available in the source record.
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?
Recruitment rates - feasibility criteria (time frame: 7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545228, which also lists 2 linked publications.
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 7 May 2024.