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| [ ...Back to search results ] | [ Print-friendly version ] |
| Multiple Symptoms Study: a feasibility study of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS) |
| ISRCTN | ISRCTN63083469 |
| ClinicalTrials.gov identifier | |
| Public title | Multiple Symptoms Study: a feasibility study of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS) |
| Scientific title | Pilot randomised controlled trial of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS) |
| Acronym | MSS |
| Serial number at source | 2009/P/GP/10 |
| Study hypothesis | Feasibility study of a GP with special interest clinic to test the hypothesis that this improves outcomes for patients with multiple medically unexplained symptoms (MMUS). |
| Lay summary | |
| Ethics approval |
Added 20/01/2010:
South East Scotland Research Ethics Committee 2 gave a favourable opinion to the study on 23rd September 2009. Amendments to the protocol were approved on the 18th November 2009. |
| Study design | Pilot randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Medically unexplained symptoms/ somatisation |
| Participants - inclusion criteria |
Patients will be eligible for inclusion if they are aged 18-64 (both males and females) and meet all of the following four criteria:
1. They have been referred at least twice to hospital outpatients in the last three years. Where referral data is only available for shorter periods the number of referrals required may be reduced. 2. Their general practice electronic notes summary does not contain any of a list of diagnostic codes representing serious illness (coronary heart disease, stroke, cancer, severe mental illness) 3. Their general practice electronic notes summary contains one or more diagnostic codes potentially indicating an MUS disorder. These codes include both MUS syndromes (e.g. fibromyalgia, irritable bowel syndrome, tension headache) and specific codes for a negative investigation which is commonly carried out for symptoms (e.g. normal endoscopy) 4. Have a Patient Health Questionnaire-14 (PHQ-14) score of >9 |
| Participants - exclusion criteria |
1. They are unable to provide informed consent to participate
2. Their GP regards their participation as clinically inappropriate 3. In the opinion of their GP, they either have a serious illness (e.g. heart disease, cancer, serious mental illness) which was not picked up on the database search or have other medical diagnoses which can fully explain their PHQ-14 score 4. They have serious illness related disability (for instance receiving daily personal care or using a wheelchair) 5. They are likely to have difficulty communicating by telephone 6. They are likely to have difficulty completing the forms and questionnaires 7. They express significant suicidal thoughts (PHQ-9 question 9 scoring >1) 8. They are currently undergoing multidisciplinary rehabilitation or management (e.g. pain clinic) 9. They are currently undergoing specialist psychological treatment |
| Anticipated start date | 01/10/2009 |
| Anticipated end date | 30/04/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Phase 1: 120; Phase 2: approximately 30 |
| Interventions |
Phase 1 will consist of i) trial of search criteria to identify patients with MUSS, ii) a postal study using the symptoms checklist (PHQ 14). Patients who score 10 or more will be regarded as potential participants for the Phase 2 pilot clinic.
Phase 2 will pilot the Multiple Symptoms Clinic. This will consist of a baseline assessment and then randomisation to either the Symptoms Clinic or usual care. The Symptoms Clinic will consist of an initial one hour consultation followed up at fortnightly intervals by three further twenty minute consultations. Details of Joint Sponsor: NHS Lothian Queens Medical Research Institute Research and Development Office 47 Little France Crescent Edinburgh EH6 4TJ United Kingdom Tel: 0131 242 3300 Fax: 0131 242 3343 Email: R&DOffice@luht.scot.nhs.uk |
| Primary outcome measure(s) |
Assess feasibility of this approach for a larger efficacy trial. Patient outcomes to be evaluated include PHQ-14, PHQ- 9 (depression) GAD-7 (anxiety) and SF-12 (health status) and a single item self-rated improvement measure, the Patient Global Impression of Change (PGIC).
Primary outcomes will be measured 12 weeks after randomisation. |
| Secondary outcome measure(s) |
Follow up interviews. Patients who have been seen in the Symptoms Clinic will be invited to be interviewed, in a place of their choice or by telephone, by a member of the research team. The aim of the semi-structured interviews will be to elicit patients views on the identification process, the conduct of this pilot study and the content of the Symptoms Clinic.
Secondary outcomes/the follow up interviews will take place at the same time as the primary outcome measures or as soon as possible thereafter. |
| Sources of funding | Chief Scientist Office, the Scottish Government (UK) (ref: CZG/2/412) |
| Trial website | |
| Publications | |
| Contact name | Dr Christopher Burton |
| Address |
Centre for Population Health Sciences
University of Edinburgh 20 West Richmond Street |
| City/town | Edinburgh |
| Zip/Postcode | EH8 9DX |
| Country | United Kingdom |
| chris.burton@ed.ac.uk | |
| Sponsor | University of Edinburgh (UK) |
| Address |
Research Governance Office
Queens Medical Research Institute 47 Little France Crescent |
| City/town | Edinburgh |
| Zip/Postcode | EH6 4TJ |
| Country | United Kingdom |
| Tel | +44 (0)131 242 9461 |
| Fax | +44 (0)131 242 9447 |
| e.currie@ed.ac.uk | |
| Sponsor website: | http://www.ed.ac.uk/home |
| Date applied | 01/09/2009 |
| Last edited | 20/01/2010 |
| Date ISRCTN assigned | 08/10/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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