The Mouth Matters in Mental Health Study

NCT05545228 | Active Not Recruiting

• 2 other identifiers: IRAS304696NIHR132853
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 5

Brief Summary

To investigate the feasibility and acceptability of a link work intervention to increase planned dental care visits for patients with severe mental illness, and through this to improve their oral health.

1. 1.To understand what constitutes best practice when delivering link work around dental visiting.
2. 2.To identify what training needs exist for support workers around link work.
3. 3.To determine whether patients with SMI are willing to be randomised to a trial targeting dental visiting.
4. 4.To understand whether it is feasible to collect clinical outcome and planned dental appointment data in this population.
5. 5.To explore if, and how, patients with severe mental illness engage with a link work intervention.
6. 6.To understand the potential factors impacting (e.g. facilitators and barriers) acceptability and delivery.

Conditions

Mental Disorders, Severe

Keywords

Mental Health; Oral Health; Dentistry

Outcome Measures

Primary Outcomes (6)

• Recruitment rates - feasibility criteria

  Data on ability to recruit randomise 84 participants to target in a 7-month recruitment window. Green ≥80%. Amber 60-79%. Red ≤59%.

  7 months

• Visiting data - feasibility criteria

  Percentage of participants with available data on dental visiting via self-report or BSA data. Green ≥90%. Amber 60-89%. Red ≤59%.

  9 months

• Clinical exam - feasibility criteria

  Percentage of participants completing the dental examination. Green ≥80%. Amber 60-79%. Red: ≤59%.

  9 months

• Adherence to intervention - feasibility criteria

  Percentage of participants receiving intervention ≥1 sessions during nine month window. Green ≥80%. Amber 60-79%. Red ≤59%.

  9 months

• Intervention and trial protocol - feasibility criteria

  Qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery. This will be via qualitative interviews with service users (participants), research staff (link workers, research assistants), and key stakeholders (referrers, managers, commissioners). Audio recordings of sessions and field notes will also be analysed.

  9 months

• Safety of intervention - feasibility criteria

  Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms. The authors will discontinue the trial if the intervention or procedures elevate risk.

  9 Months

Secondary Outcomes (16)

• Brief Pain Inventory - short form

  Baseline and 9 month assessments

• Manchester Orofacial Pain Disability Scale

  Baseline and 9 month assessments

• Oral Health Impact Profile

  Baseline and 9 month assessments

• Confidence around dental visiting

  Baseline and 9 month assessments

• Rosenberg Self-esteem Scale (RSES)

  Baseline and 9 month assessments

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive treatment as usual plus a link work intervention to support access to dental services.

Behavioral: Link work intervention

Treatment as usual group

NO INTERVENTION

Participants to receive treatment as usual and will not receive the intervention.

Interventions

Link work intervention BEHAVIORAL

Intervention from a link worker to support participants to access dental services.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>18 years
• Able to provide informed consent
• Receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention Team at the point of referral
• No routine and planned dental appointment in the past 3 years. The person should not have accessed a dental service (e.g. high street dentist, special care dentist service) for routine or planned dental care in the past 3 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. The researchers do not consider emergency dental care (e.g. attendance at A\&E, dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.

You may not qualify if:

• Inpatient status on a psychiatric or secure ward. The researchers will allow participants in supported living to take part as long as they are in receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention for Psychosis Service
• 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). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and the referrer in approximately 1 month's time (or a time period agreed in collaboration with the individual) to determine if the risk has subsided to a point where they are now eligible.
• Enrolled in a dental trial

Sponsors & Collaborators

• Lancaster University: lead

Study Sites (5)

Pennine Care NHS Foundation Trust

Ashton-under-Lyne, Great Manchester, OL6 7SR, United Kingdom

Location

Greater Manchester Mental Health NHS Foundation Trust

Manchester, Great Manchester, M25 3BL, United Kingdom

Location

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

Lancaster University

Lancaster, Lancashire, LA1 4YW, United Kingdom

Location

Lancashire and South Cumbria NHS Foundation Trust

Preston, Lancashire, PR2 8DW, United Kingdom

Location

Related Publications (2)

• Palmier-Claus J, Morris A, French P, Griffiths R, Aggarwal VR, Berry K, Gkioni E, Harris R, Laverty L, Lobban F, Procter S, Kerry E, Newens C, Mupinga P, Golby R, Valemis K, Oakes L, Fazekas F, Perry A, Shiers D, Lodge C, Hilton C, Dawber A, Elliott E, Lunat F, Burnside G. A Link Work Intervention to Facilitate Dental Visiting in People With Severe Mental Illness: A Two-Arm, Multi-Site, Assessor Blind, Randomised Feasibility Trial With Dental Record Linkage. Community Dent Oral Epidemiol. 2025 Oct;53(5):580-586. doi: 10.1111/cdoe.70002. Epub 2025 Aug 4.

  PMID: 40755121 DERIVED

• Hilton C, Morris A, Burnside G, Harris R, Aggarwal VR, Procter S, Griffiths R, French P, Laverty L, Lobban F, Berry K, Shiers D, Golby R, Fazekas F, Valemis K, Perry A, Newens C, Kerry E, Mupinga P, Gkioni E, Lodge C, Dawber A, Elliott E, Lunat F, Palmier-Claus J. A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper. Pilot Feasibility Stud. 2023 Sep 8;9(1):157. doi: 10.1186/s40814-023-01383-2.

  PMID: 37684682 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Jasper Palmier-Claus, PhD, DClinPsy

  Lancaster University

  PRINCIPAL INVESTIGATOR

• Rebecca Harris, BDS, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A feasibility single-blinded randomised controlled trial

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 19, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)