Scottish Neurological Symptoms Study 2: Symptom Management Research Trial in Neurology

ISRCTN	ISRCTN47705219
DOI	https://doi.org/10.1186/ISRCTN47705219
Protocol serial number	MRC 68076
Sponsor	Edinburgh University (UK)
Funder	Medical Research Council (UK) (ref: 68076)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Michael Sharpe
Scientific

University of Edinburgh Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom

Phone	+44 (0)131 5376672
Email	michael.sharpe@ed.ac.uk

Primary study design	Interventional
Study design	Two-arm two-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SNSS2: SMaRT Neurology
Study objectives	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(s)	Ethics approval received from the Scotland A Committee on 27/10/2005 (ref: 05/MRE00/96)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Patients' self-rated global health improvement as measured on Clinical Global Improvement (CGI) scales at 3 months.
Key secondary outcome measure(s)	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
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	130
Key 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.
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	31/05/2006

University of Edinburgh Division of Psychiatry

Edinburgh
EH10 5HF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/08/2011		Yes	No