Clinical trial NCT00604604: Postpartum Depression Prevention Trial
Official title: An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-01-30
Enrollment: 702
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to evaluate the effect of peer (mother-to-mother) support on the prevention of postpartum depression among mothers identified as high-risk.

Detailed description: Many new mothers from diverse cultures experience postpartum depression (PPD), a serious form of maternal morbidity with well documented health consequences for the mother, child, and family. While the cause of PPD remains unclear, research consistently demonstrates the importance of psychosocial variables. The purpose of this randomized controlled trial is to evaluate the effect of peer (mother-to-mother) support on the prevention of PPD among mothers identified as high-risk. Public health nurses using the Edinburgh Postnatal Depression Scale (EPDS) screened mothers who were less than 2 weeks postpartum in the regions of Toronto, Peel, Halton, York, Windsor, Sudbury, and Ottawa. Eligible and consenting mothers were randomized to either a control group (usual postpartum care) or experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session). Diverse study outcomes, including depressive symptomatology and health service utilization, were assessed at 12 and 24 weeks postpartum. The results from this trial will make substantive contributions in six areas: (1) develop the body of knowledge concerning the effectiveness of peer support in the prevention of PPD among at-risk mothers; (2) advance our understanding of the advantages and disadvantages of using peer volunteers as a complementary form of health care; (3) provide an economic evaluation of a peer support intervention; (4) offer a detailed analysis of peer support interactions including supportive functions provided, types of relationships developed, and health benefits perceived; (5) investigate the utility of screening at-risk mothers using the EPDS in general public health nursing practice; and (6) present valuable information regarding PPD among a multicultural Canadian population.

Eligibility criteria: 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

Primary outcomes:
measure: Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 12 weeks postpartum
Secondary outcomes:
measure: 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
timeFrame: 12 and 24 weeks postpartum
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Peel Health Department
state: Ontario
city: Oakville
country: Canada
facility: Halton Region Health Department
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Public Health
state: Ontario
city: Richmond Hill
country: Canada
facility: York Region Health Services
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury & District Health Unit
state: Ontario
city: Toronto
country: Canada
facility: Toronto Public Health
state: Ontario
city: Windsor
country: Canada
facility: Windsor Essex County Health Unit
state: Ontario
Study officials:
affiliation: Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
name: Cindy-Lee Dennis, PhD
role: PRINCIPAL_INVESTIGATOR
References: