Condition category
Mental and Behavioural Disorders
Date applied
01/09/2009
Date assigned
08/10/2009
Last edited
27/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Burton

ORCID ID

Contact details

Centre for Population Health Sciences
University of Edinburgh
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom
chris.burton@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009/P/GP/10

Study information

Scientific title

Pilot randomised controlled trial of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS)

Acronym

MSS

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).

Ethics approval

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.

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2009

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Phase 1: 120; Phase 2: approximately 30

Participant 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

Recruitment start date

01/10/2009

Recruitment end date

30/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Population Health Sciences
Edinburgh
EH8 9DX
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

Research Governance Office
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH6 4TJ
United Kingdom
+44 (0)131 242 9461
e.currie@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk/home

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22327629

Publication citations

  1. Results

    Burton C, Weller D, Marsden W, Worth A, Sharpe M, A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial., BMJ Open, 2012, 2, e000513, doi: 10.1136/bmjopen-2011-000513.

Additional files

Editorial Notes