Postpartum Depression Prevention Trial

Postpartum Depression Clinical Trial

Official title:

An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604604
• Other study ID #: MCT-66874
• Secondary ID: ISRCTN68337727
• Status: Completed
• Phase: N/A
• First received: January 17, 2008
• Last updated: June 2, 2015
• Start date: August 2004
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University of Toronto
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
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	Sudbury & District Health Unit	Sudbury	Ontario
Canada	Toronto Public Health	Toronto	Ontario
Canada	Windsor Essex County Health Unit	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)		12 weeks postpartum	No
Secondary	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		12 and 24 weeks postpartum	No