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ISRCTN
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ISRCTN51850035
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ClinicalTrials.gov identifier
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Public title
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A randomised, controlled, single blind pilot study to evaluate the efficacy of a mindfulness stress reduction intervention as an adjunct therapy in moderate to severe psoriasis.
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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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N0013137386
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Study hypothesis
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A randomised, controlled, single blind pilot study to evaluate the efficacy of a mindfulness stress reduction intervention as an adjunct therapy in moderate to severe psoriasis.
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Lay summary
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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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Randomised single blind 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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Psoriasis
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Participants - inclusion criteria
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Approx 50 adult psoriasis patients attending St John's Institute of Dermatology as an out-patient who have had the diagnosis of psoriasis for at least one year.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/12/2003
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Anticipated end date
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01/07/2004
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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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50
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Interventions
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Patients with moderate to severe psoriasis will be randomly assigned at a ratio of 1:1 to receive a mindfulness stress reduction audio tape or nothing (control) as an adjunct treatment to their conventional psoriasis treatment plan. The experimental group subjects will be required to listen to the tape and practice the relaxation technique 3 times a week for 8 weeks. Both groups will be seen at week 0, 4 and 8 for psoriasis severity scores, and psychological assessment scores to evaluate effect.
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Primary outcome measure(s)
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1. Psoriasis severity measured using the Psoriasis Severity Index (PASI)
2. Mental health using Hospital Anxiety and Depression Scale (HADS)
3. Mental health using Penn State Worry Questionnaire (PSWQ)
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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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Guy's and St Thomas' NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Ms
Penelope
Shirlaw
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Address
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Oral Medicine Department
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 4399
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Email
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pepe.shirlaw@gstt.sthames.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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23/09/2009
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Date ISRCTN assigned
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30/09/2004
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