Postpartum Depression Prevention Trial - Full Text View

Sponsors and Collaborators:	University of Toronto Canadian Institutes of Health Research (CIHR)
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00604604

Purpose

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.

Condition	Intervention
Postpartum Depression	Behavioral: Peer support

MedlinePlus related topics: Depression Postpartum Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title:	An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression

Further study details as provided by University of Toronto:

Primary Outcome Measures:

Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 12 weeks postpartum ] [ Designated as safety issue: No ]

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 [ Time Frame: 12 and 24 weeks postpartum ] [ Designated as safety issue: No ]

Enrollment:	702
Study Start Date:	August 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Control group (usual postpartum care)	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.
2: Experimental Experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session)	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.

Arms

Assigned Interventions

1: No Intervention

Control group (usual postpartum care)

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.

2: Experimental

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

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.

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

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604604

Locations

Canada, Ontario
Toronto Public Health
Toronto, Ontario, Canada, M2N 5V7
Peel Health Department
Mississauga, Ontario, Canada, L5R 4B2
Halton Region Health Department
Oakville, Ontario, Canada, L6M 3L1
Ottawa Public Health
Ottawa, Ontario, Canada, K2G 6J8
Windsor Essex County Health Unit
Windsor, Ontario, Canada, N9J 4J8
Sudbury & District Health Unit
Sudbury, Ontario, Canada, P3E 3A3
York Region Health Services
Richmond Hill, Ontario, Canada, L4B 4N7

Sponsors and Collaborators

University of Toronto

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Cindy-Lee Dennis, PhD

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto

More Information

Responsible Party:	Lawrence S. Bloomberg Faculty of Nursing, University of Toronto ( Dr. Cindy-Lee Dennis )
Study ID Numbers:	MCT-66874, ISRCTN68337727
Study First Received:	January 17, 2008
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00604604
Health Authority:	Canada: University of Toronto

Study placed in the following topic categories:

Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 14, 2009