Contact information
Type
Scientific
Primary contact
Prof Michael Sharpe
ORCID ID
Contact details
University of Edinburgh Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
+44 (0)131 5376672
michael.sharpe@ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC 68076
Study information
Scientific title
Acronym
SNSS2: SMaRT Neurology
Study hypothesis
Patients with neurological symptoms that are diagnosed as 'not at all' or only 'somewhat' explained by disease who receive Cognitive Behavioural Self Help treatment in addition to Optimised Usual Care, will have a 10% greater mean improvement as measured on a five point clinical global improvement scale compared to patients receiving Optimised Usual Care alone, when measured 3 months after commencement of treatment.
Ethics approval
Ethics approval received from the Scotland A Committee on 27/10/2005 (ref: 05/MRE00/96)
Study design
Two-arm two-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Medically unexplained symptoms
Intervention
1. Optimised usual care
2. Optimised usual care with the addition of four sessions of Cognitive Behavioural Self Help Therapy by use of a manual with the support of a treating nurse specialist
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Patients' self-rated global health improvement as measured on Clinical Global Improvement (CGI) scales at 3 months.
Secondary outcome measures
Patients' self rated improvement in decrease in total symptom burden, change in presenting symptoms, improvement in SF12 score, and change in Hospital Anxiety and Depression (HAD) score, Whitley score, illness beliefs and satisfaction with care
Overall trial start date
01/02/2006
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 18 years or more who are attending Glasgow or Edinburgh Neurology Centres for the first time and who are deemed by the treating neurologist to have symptoms that are 'not at all' or only 'somewhat' explained by disease.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
1. Less than 18 years of age
2. Cognitive impairment
3. Insufficient ability to read and write English
4. Serious psychiatric illness
5. Actively suicidal
6. Receiving psychiatric or psychological treatment
7. Presenting solely with chronic daily headache
8. Neurologist/researcher considers participation inappropriate to patient's needs
9. Unable to travel to attend treatment sessions
Recruitment start date
01/02/2006
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Edinburgh Division of Psychiatry
Edinburgh
EH10 5HF
United Kingdom
Sponsor information
Organisation
Edinburgh University (UK)
Sponsor details
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9253
Paul.McGuire@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: 68076)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21795652
Publication citations
-
Results
Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A, Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial., Neurology, 2011, 77, 6, 564-572, doi: 10.1212/WNL.0b013e318228c0c7.