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Antidepressant drug therapy vs a community-based psychosocial intervention for the treatment of moderate postnatal depression: a pragmatic randomised controlled trial
ISRCTN ISRCTN16479417
DOI 10.1186/ISRCTN16479417
ClinicalTrials.gov identifier
EudraCT number
Public title Antidepressant drug therapy vs a community-based psychosocial intervention for the treatment of moderate postnatal depression: a pragmatic randomised controlled trial
Scientific title
Acronym RESPOND
Serial number at source HTA 02/07/04
Study hypothesis The study proposes to compare the effectiveness and cost-effectiveness of antidepressant drug therapy versus a community-based psychosocial intervention (Health Visitor delivered non-directive counselling) in the treatment of moderate postnatal depression.

Protocol can be found at: http://www.hta.ac.uk/protocols/200200070004.pdf
More details can be found at: http://www.hta.ac.uk/1373

Please note that, as of 11 January 2008, the anticipated start and end dates of this trail have been updated from 1 March 2004 and 30 September 2007 to 1 June 2004 and 30 April 2008, respectively.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration.
Study design Two arm multi-centre pragmatic randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Postnatal depression
Participants - inclusion criteria Women with post natal depression up to 3 months post natal
Participants - exclusion criteria Not provided at time of registration.
Anticipated start date 01/06/2004
Anticipated end date 30/04/2008
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration.
Interventions A two arm multi-centre pragmatic randomised controlled trial, with randomisation at the level of the individual woman. Women who reach the threshold for inclusion (EPDS>12, CIS-R>11) at 8 weeks will be randomised to either antidepressants or a 4 week waiting list for counselling. Women who do not respond to the allocated therapy in their group will be offered the opportunity to either switch or combined therapies after the primary outcome has been measured (4 weeks for antidepressants, 18 weeks for counselling) Thus the research design allows women to receive both antidepressants and psychological therapy is required.
Primary outcome measure(s) The primary outcome measure is the EPDS at 4 weeks, 18 weeks and 44 weeks. In addition, the trial will use the SF-36 as a generic measure of functional quality of life, the EQ5D for economic analysis, the MAMA for parenting skills and attitudes towards the baby, the GRIMS for the quality of the marital relationship. The trial will ask partners to complete the GHQ12 the PAPA and the GRIMS. At 12 months we will assess the family milieu using the HOME and the child's development using the Bayley scales.
Secondary outcome measure(s) Not provided at time of registration.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20860888
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21812968
Contact name Prof  Deborah  Sharp
  Address Academic Unit of primary care
University of Bristol
  City/town Bristol
  Zip/Postcode BS8 2AA
  Country United Kingdom
  Tel +44 (0)117 3313812
  Fax +44 (0)117 3313813
  Email debbie.sharp@bris.ac.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 16/09/2003
Last edited 08/08/2011
Date ISRCTN assigned 16/09/2003
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