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Postpartum Depression Prevention Trial

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Peer support
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peel Health Department
  • Halton Region Health Department
  • Ottawa Public Health
  • York Region Health Services
  • Sudbury & District Health Unit
  • Toronto Public Health
  • Windsor Essex County Health Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Control group (usual postpartum care)

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

Outcomes

Primary Outcome Measures

Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2008
Last Updated
June 2, 2015
Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00604604
Brief Title
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

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
702 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Control group (usual postpartum care)
Arm Title
2
Arm Type
Experimental
Arm Description
Experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session)
Intervention Type
Behavioral
Intervention Name(s)
Peer support
Other Intervention Name(s)
Mother-to-mother support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
12 weeks postpartum
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy-Lee Dennis, PhD
Organizational Affiliation
Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peel Health Department
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5R 4B2
Country
Canada
Facility Name
Halton Region Health Department
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 3L1
Country
Canada
Facility Name
Ottawa Public Health
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6J8
Country
Canada
Facility Name
York Region Health Services
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 4N7
Country
Canada
Facility Name
Sudbury & District Health Unit
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 3A3
Country
Canada
Facility Name
Toronto Public Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 5V7
Country
Canada
Facility Name
Windsor Essex County Health Unit
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9J 4J8
Country
Canada

12. IPD Sharing Statement

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Postpartum Depression Prevention Trial

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