The Mouth Matters in Mental Health Trial -2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLancashire and South Cumbria NHS Foundation Trust
About this 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:
1. 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. 2. The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone. 3. The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Link work intervention
BehavioralThe 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.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Treatment as usualNo intervention 0 interventions
Group B: Treatment as usual plus a link work interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Attendance at a planned care appointments
As measured by the National Health Services Business Services Authority (NHS BSA).
Time frame
From baseline to nine-month follow-up assessment.2
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
Time frame
From baseline to nine-month follow-up assessment .Secondary outcomes
1
Self-reported attendance at a planned dental appointment.
Self-report dental attendance items.
Time frame
From baseline to nine-month follow-up assessment.2
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).
Time frame
From baseline to nine-month follow-up assessment3
Confidence around dental visiting
Single item of self-efficacy around attendance. Range 1-7. A higher score indicates greater confidence around dental visiting.
Time frame
From baseline to nine-month follow-up assessment.4
Self-esteem
Rosenberg Self-Esteem Scale. Range: 0-30. A higher score indicates better self-esteem.
Time frame
From baseline to nine-month follow-up assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lancashire and South Cumbria NHS Foundation Trust
Lead sponsor
Lancaster University
Sponsor institution
Greater Manchester Mental Health NHS Foundation Trust
Collaborator
Pennine Care NHS Foundation Trust
Collaborator
Northumberland, Tyne and Wear NHS Foundation Trust
Collaborator
South London and Maudsley NHS Foundation Trust
Collaborator
Lancaster University
Collaborator
University of Liverpool
Collaborator
University of Leeds
Collaborator
University of Manchester
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov