The Mouth Matters in Mental Health Trial -2

Sponsor
Lancashire and South Cumbria NHS Foundation Trust
Study ID
NCT07470437
Status
Not Yet Recruiting

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Conditions

  • Mental Health
  • Oral Health Care
  • Psychosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Link work intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Treatment as usual
    Treatment as usual will include any treatments or services that the participant would normally have access to outside of the trial. For people with severe mental illness this may include support from a care coordinator, support worker, psychologist, occupational therapist, and/or psychiatrist for care around their mental health. Treatment as usual may include medication and case management. The investigators will monitor, rather than withhold, assessment and treatment for oral health in the treatment as usual arm.
  • Experimental: Treatment as usual plus a link work intervention
    Participants in this arm will receive treatment as usual plus the link work intervention. This will consist of six sessions with a link worker over nine-months who will offer practical and emotional support around accessing a routine dental appointment.

Primary Outcome Measure

Attendance at a planned care appointments [ Time Frame: From baseline to nine-month follow-up assessment. ]

Central Contacts

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