Postpartum Depression Prevention Trial

NCT ID: NCT00604604

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 702 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2007-04-30

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.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Control group (usual postpartum care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session)

Group Type: EXPERIMENTAL

Peer support

Intervention Type: BEHAVIORAL

Mothers allocated to the peer support group had access to all of the standard community postpartum services in addition to having received 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 with a new mother was initiated within 48 to 72 hours of trial enrolment and then as frequently as the dyad deemed necessary; a minimum of four contacts were required.

Interventions

Peer support

Mothers allocated to the peer support group had access to all of the standard community postpartum services in addition to having received 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 with a new mother was initiated within 48 to 72 hours of trial enrolment and then as frequently as the dyad deemed necessary; a minimum of four contacts were required.

Intervention Type: BEHAVIORAL

Other Intervention Names

Mother-to-mother support

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto

Principal Investigators

Cindy-Lee Dennis, PhD

Role: PRINCIPAL_INVESTIGATOR

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto

Locations

Sudbury & District Health Unit

Greater Sudbury, Ontario, Canada

Peel Health Department

Mississauga, Ontario, Canada

Halton Region Health Department

Oakville, Ontario, Canada

Ottawa Public Health

Ottawa, Ontario, Canada

York Region Health Services

Richmond Hill, Ontario, Canada

Toronto Public Health

Toronto, Ontario, Canada

Windsor Essex County Health Unit

Windsor, Ontario, Canada

Countries

Canada

Other Identifiers

ISRCTN68337727

Identifier Type: -

Identifier Source: secondary_id

MCT-66874

Identifier Type: -

Identifier Source: org_study_id