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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT00604604 |
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Date of registration:
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17/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Postpartum Depression Prevention Trial
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Scientific title:
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An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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702 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00604604 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Cindy-Lee Dennis, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lawrence S. Bloomberg Faculty of Nursing, University of Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- live birth
- discharged from hospital
- <2 weeks postpartum
- scored >9 on the EPDS
- availability of a peer volunteer who speaks the potential participant's language
Exclusion Criteria:
- infant not discharged home with mother
- current use of anti-depressant or anti-psychotic medication
- prior self-reported mental illness, including prior PPD, will NOT be an exclusion
criterion
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Depression
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Intervention(s)
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Behavioral: Peer support
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Primary Outcome(s)
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Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)
[Time Frame: 12 weeks postpartum]
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Secondary Outcome(s)
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State Anxiety Inventory (STAI); UCLA Loneliness Scale; Maternal Health Service Utilization and Cost of Care Questionnaire; Peer Support Evaluation Inventory; Peer Volunteer Experience Questionnaire; Peer Volunteer Activity Log
[Time Frame: 12 and 24 weeks postpartum]
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Secondary ID(s)
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ISRCTN68337727
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MCT-66874
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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