The Mouth Matters in Mental Health Trial –2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares treatment as usual with and without a link work intervention for adults with severe mental illness. It will recruit 480 participants from five NHS Trusts and follow them for nine months, measuring dental attendance and oral health-related quality of life, plus cost-effectiveness. A qualitative process evaluation will explore how the intervention works and how it could be implemented in real-world settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Lancashire & South Cumbria NHS Foundation Trust
  Preston, Lancashire, United Kingdom Recruiting
• Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
  Newcastle upon Tyne, Northumberland, United Kingdom Recruiting
• Pennine Care NHS Foundation Trust
  Ashton-under-Lyne, United Kingdom Recruiting
• Greater Manchester Mental Health NHS Foundation Trust
  Manchester, United Kingdom Recruiting
• South London and Maudsley NHS Foundation Trust
  London, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Dr Palmier-Claus, PhD, DClinPsy
• Email: J.Palmier-Claus@lancaster.ac.uk
• Phone: +44 1772 773500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.