NCT07470437

The Mouth Matters in Mental Health Trial -2

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Lancashire and South Cumbria NHS Foundation Trust · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Link work intervention	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-07-31
• Completion: 2029-07-31
• First posted: 2026-03-13
• Last updated: 2026-03-17

Locations

5 sites across 1 country: United Kingdom