The Mouth Matters in Mental Health Trial -2

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.

Conditions

• Mental Health
• Oral Health Care
• Psychosis

Interventions

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.

Sponsors & Collaborators

• Greater Manchester Mental Health NHS Foundation Trust

  collaborator OTHER

• Pennine Care NHS Foundation Trust

  collaborator OTHER_GOV

• Northumberland, Tyne and Wear NHS Foundation Trust

  collaborator OTHER

• South London and Maudsley NHS Foundation Trust

  collaborator OTHER

• Lancaster University

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• King's College London

  collaborator OTHER

• Lancashire and South Cumbria NHS Foundation Trust

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2029-07-31

Completion

2029-07-31

Countries

• United Kingdom

Study Locations