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Effectiveness of peer support for the prevention of postpartum depression
ISRCTN ISRCTN68337727
DOI 10.1186/ISRCTN68337727
ClinicalTrials.gov identifier NCT00604604
EudraCT number
Public title Effectiveness of peer support for the prevention of postpartum depression
Scientific title A randomised controlled trial to evaluate the effectiveness of peer (mother-to-mother) support for the prevention of postpartum depression
Acronym N/A
Serial number at source MCT 66874
Study hypothesis Among mothers at-risk for Post-Partum Depression (PPD) (Edinburgh Postnatal Depression Scale [EPDS] score more than nine), what is the effect of peer support on PPD at 12 weeks postpartum?
Lay summary
Ethics approval Approval received from the University of Toronto research ethics board and other participating sites in the summer of 2004.
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Postpartum Depression
Participants - inclusion criteria 1. Live birth
2. Aged 18 - 49 years old, female
2. Discharged from hospital
3. Less than two weeks postpartum
4. Scored more than nine on the EPDS
5. Availability of a peer volunteer who speaks the potential participant's language
Participants - exclusion criteria 1. Infant not discharged home with mother
2. Current use of anti-depressant or anti-psychotic medication

A prior self-reported mental illness, including prior PPD, will not be an exclusion criterion.
Anticipated start date 01/07/2004
Anticipated end date 01/05/2007
Status of trial Completed
Patient information material
Target number of participants 700
Interventions Mothers allocated to the peer support group will have access to all of the standard community postpartum services in addition to receiving telephone-based support from a peer volunteer (a mother who has previously experienced, and recovered from, postpartum depression and has participated in a 4-hour training session). Telephone contact will be initiated within 48 to 72 hours of trial randomisation and then as frequently as the dyad deems necessary.
Primary outcome measure(s) Postpartum Depression (PPD), as diagnosed by the Structured Clinical Interview (SCID-I) for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) at 12 weeks postpartum.
Secondary outcome measure(s) 1. PPD, as diagnosed by the SCID-I, at 24 weeks postpartum
2. Depressive symptomatology, as measured by the EPDS, at 12 and 24 weeks postpartum
3. Anxiety, as measured by the Spielberger State-Anxiety Inventory, at 12 and 24 weeks postpartum
4. Loneliness, as measured by the short-version University of California, Los Angeles (UCLA) Loneliness Scale, at 12 and 24 weeks postpartum
5. Health Service Utilisation, as measured by a modified version of the Health Service Utilisation and Cost of Care Questionnaire, at 12 and 24 weeks postpartum
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 66874)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19147637
Contact name Dr  Cindy-Lee  Dennis
  Address University of Toronto
Lawrence S. Bloomberg Faculty of Nursing
155 College Street, Suite 130
  City/town Toronto, ON
  Zip/Postcode M5T 1P8
  Country Canada
  Tel +1 416 946 8608
  Email cindylee.dennis@utoronto.ca
Sponsor University of Toronto (Canada)
  Address 27 King's College Circle
Toronto
  City/town Ontario
  Zip/Postcode M5S 1A1
  Country Canada
  Tel +1 416 978 2163
  Fax +1 416 971 2010
  Email audrey.cheung@utoronto.ca
  Sponsor website: http://www.utoronto.ca/
Date applied 19/07/2004
Last edited 10/06/2009
Date ISRCTN assigned 22/07/2004
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