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Psychological interventions for postnatal depression - randomised controlled trial and economic evaluation
ISRCTN ISRCTN92195776
ClinicalTrials.gov identifier
Public title Psychological interventions for postnatal depression - randomised controlled trial and economic evaluation
Scientific title
Acronym PONDER
Serial number at source HTA 99/33/51
Study hypothesis 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.
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mental and behavioural disorders: Depression, anxiety, neuroses; Pregnancy and childbirth: Childbirth
Participants - inclusion criteria Women with live babies who will remain with their GP for 4 months
Participants - exclusion criteria Unable to give informed consent
Anticipated start date 01/04/2003
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 4000 women from 93 General Practices
Interventions Non-directive counselling (NDC) v Cognitive Behavioural-type Counselling (CBC) delivered by Health Visitors in their usual clinical setting v standard care
Primary outcome measure(s) 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
Secondary outcome measure(s) Not provided at time of registration.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications
Contact name Ms  Jane  Morrell
  Address School of Health & Related Research
University of Sheffield
12 Victoria Road
Broomhall
  City/town Sheffield
  Zip/Postcode S10 2DL
  Country United Kingdom
  Tel +44 (0)114 249 2500
  Fax +44 (0)114 272 4095
  Email morrello@blueyonder.co.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 25/01/2008
Date ISRCTN assigned 25/04/2003
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