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ISRCTN
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ISRCTN33231235
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ClinicalTrials.gov identifier
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Public title
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Psychological treatment in the regulation of long-term hypnotic drug use
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 95/30/02
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Study hypothesis
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In a randomised controlled trial the proposed study would evaluate the costs and consequences of using a structured "package" of psychological treatments for insomnia to promote and maintain low frequency, intermittent hypnotic drug consumption among those unwilling to discontinue their medication.
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Ethics approval
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Not provided at time of registration.
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Study design
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Pragmatic cluster randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and behavioural disorders: Other mental disorder
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Participants - inclusion criteria
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Patients aged 31-92 with chronic sleep problems who had been receiving repeat prescriptions for hypnotic drugs for at least one month
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/08/1998
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Anticipated end date
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31/07/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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209
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Interventions
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Structured package vs standard care
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Primary outcome measure(s)
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Main outcomes included: global sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI); frequency of life (as measured by the SF-36); NHS service costs; and overall cost utility. For statistical analysis all non-categorical outcomes were modelled as baseline minus follow-up change scores
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14960215
2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14960254
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Contact name
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Prof
Nigel
Mathers
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Address
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Institute of General Practice and Primary Care
University of Sheffield
Community Sciences Centre
Northern General Hospital
Herries Road
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City/town
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Sheffield
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Zip/Postcode
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S5 7AU
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Country
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United Kingdom
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Tel
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+44 (0)114 271 5922
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Fax
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+44 (0)114 242 2136
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Email
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n.mathers@sheffield.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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01/09/2009
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Date ISRCTN assigned
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25/04/2003
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