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ISRCTN
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ISRCTN92195776
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ClinicalTrials.gov identifier
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Public title
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Psychological interventions for postnatal depression - randomised controlled trial and economic evaluation
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Scientific title
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Acronym
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PONDER
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Serial number at source
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HTA 99/33/51
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Study hypothesis
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The central aim of the study is to assess the costs, effectiveness and broad impact of screening for postnatal depression alongside two counselling interventions, non-directive counselling and cognitive behavioural counselling, delivered by health visitors in their usual clinical setting. Screened women at risk of depression will be interviewed to assess symptom severity. The study will assess effectiveness according to severity, history and duration of depression. The design will reflect the practicalities of primary care service delivery and will ensure that a wide range of effects is identified. In addition, the trial will examine an important practical question, with no loss of statistical power, on the efficiency and value of face-to-face screening by health visitors, compared with postnatal screening.
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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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Mental and behavioural disorders: Depression, anxiety, neuroses; Pregnancy and childbirth: Childbirth
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Participants - inclusion criteria
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Women with live babies who will remain with their GP for 4 months
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Participants - exclusion criteria
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Unable to give informed consent
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Anticipated start date
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01/04/2003
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Anticipated end date
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31/03/2006
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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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4000 women from 93 General Practices
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Interventions
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Non-directive counselling (NDC) v Cognitive Behavioural-type Counselling (CBC) delivered by Health Visitors in their usual clinical setting v standard care
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Primary outcome measure(s)
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The efficiency and value of face-to-face screening by health visitors, compared with postnatal screening. Women's postal questionnaires, casenotes and activity data will be used to monitor changes in symptoms, health outcomes, hospital admissions, NHS service use, family well-being and infant progress to eighteen months
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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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Contact name
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Ms
Jane
Morrell
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Address
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School of Health & Related Research
University of Sheffield
12 Victoria Road
Broomhall
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City/town
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Sheffield
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Zip/Postcode
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S10 2DL
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Country
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United Kingdom
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Tel
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+44 (0)114 249 2500
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Fax
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+44 (0)114 272 4095
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Email
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morrello@blueyonder.co.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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25/01/2008
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Date ISRCTN assigned
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25/04/2003
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