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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63083469
Enrollment
120
Registered
2009-10-08
Start date
2009-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medically unexplained symptoms/ somatisation Mental and Behavioural Disorders Somatoform disorders

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 potentia

Sponsors

University of Edinburgh (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026