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ISRCTN
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ISRCTN33308608
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ClinicalTrials.gov identifier
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Public title
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A pragmatic randomised controlled trial to assess the clinical effectiveness of 'guided self-help' versus 'waiting list control' in the management of anxiety and depression in primary care. Self-Help in Anxiety and DEpression (SHADE).
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Scientific title
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Acronym
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SHADE
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Serial number at source
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N/A
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Study hypothesis
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Provision of guided self-help will produce superior clinical outcomes to waiting list management at 3-month follow-up for patients with anxiety and depression
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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 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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Anxiety/depression
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Participants - inclusion criteria
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Adult patients with anxiety/depression referred from primary care to one of three Greater Manchester psychological therapy services and currently with 3+ months remaining on the waiting list.
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Participants - exclusion criteria
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1. Under 18 years of age
2. Baseline score <14 on the Beck Depression Inventory (BDI) and <11 on anxiety scale of the Hospital Anxiety and Depression Scale (HADS)
3. Referred for therapy from source other than primary care
4. Less than 3 months remaining on therapy service waiting list
5. Poor proficiency in English (i.e. inability to complete questionnaires or read the self-help manual)
6. Active suicidal thoughts
7. Current substance misuse
8. Organic brain disease
9. Current contact with specialist mental health services
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/01/2005
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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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114
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Interventions
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Intervention group - use of a written self-help manual and up to 4 brief (15-30 minute) face-to-face facilitation sessions with a graduate assistant psychologist while on waiting list.
Waiting list control group - patients remain on waiting list, with routine support (as required) from primary care provider.
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Primary outcome measure(s)
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The Hospital Anxiety and Depression Scale (HADS) score
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Secondary outcome measure(s)
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1. Beck Depression Inventory (BDI)
2. Social Adjustment Scale (SAS)
3. Clinical Outcomes in Routine Evaluation scale (CORE)
4. Patient satisfaction and other self-report measures of the treatment process
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Sources of funding
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National Primary Care Research and Development Centre (NPCRDC) (UK) - via core funding from the Department of Health
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Trial website
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http://www.npcrdc.man.ac.uk/ResearchDetail.cfm?ID=73
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16219121
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Contact name
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Dr
Peter
Bower
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Address
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National Primary Care Research and Development Centre (NPCRDC)
5th Floor
Williamson Building
University of Manchester
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Tel
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+44 (0)161 275 7638
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Fax
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+44 (0)161 275 7600
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Email
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peter.bower@manchester.ac.uk
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Sponsor
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National Primary Care Research and Development Centre (NPCRDC) (UK)
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Address
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5th Floor
Williamson Building
University of Manchester
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Date applied
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11/04/2005
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Last edited
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14/09/2009
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Date ISRCTN assigned
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16/05/2005
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