Multiple Symptoms Study: a feasibility study of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS)

ISRCTN	ISRCTN63083469
DOI	https://doi.org/10.1186/ISRCTN63083469
Secondary identifying numbers	2009/P/GP/10

Submission date: 01/09/2009
Registration date: 08/10/2009
Last edited: 27/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christopher Burton
Scientific

Centre for Population Health Sciences
University of Edinburgh
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom

Email	chris.burton@ed.ac.uk

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Pilot randomised controlled trial of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS)
Study acronym	MSS
Study objectives	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).
Ethics approval(s)	Added 20/01/2010: South East Scotland Research Ethics Committee 2 gave a favourable opinion to the study on 23/09/2009. Amendments to the protocol were approved on the 18/11/2009.
Health condition(s) or problem(s) studied	Medically unexplained symptoms/ somatisation
Intervention	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
Intervention type	Other
Primary outcome measure	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 measures	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.
Overall study start date	01/10/2009
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	Both
Target number of participants	Phase 1: 120; Phase 2: approximately 30
Key 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
Key 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
Date of first enrolment	01/10/2009
Date of final enrolment	30/04/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Centre for Population Health Sciences

Edinburgh
EH8 9DX
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

Research Governance Office
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH6 4TJ
Scotland
United Kingdom

Phone	+44 (0)131 242 9461
Email	e.currie@ed.ac.uk
Website	http://www.ed.ac.uk/home
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

Chief Scientist Office, the Scottish Government (UK) (ref: CZG/2/412)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/02/2012		Yes	No