Condition category
Mental and Behavioural Disorders
Date applied
19/07/2004
Date assigned
22/07/2004
Last edited
20/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cindy-Lee Dennis

ORCID ID

Contact details

University of Toronto
Lawrence S. Bloomberg Faculty of Nursing
155 College Street
Suite 130
Toronto
ON
M5T 1P8
Canada
+1 416 946 8608
cindylee.dennis@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00604604

Protocol/serial number

MCT 66874

Study information

Scientific title

A randomised controlled trial to evaluate the effectiveness of peer (mother-to-mother) support for the prevention of postpartum depression

Acronym

Study hypothesis

Among mothers at-risk for Post-Partum Depression (PPD) (Edinburgh Postnatal Depression Scale [EPDS] score more than nine), what is the effect of peer support on PPD at 12 weeks postpartum?

Ethics approval

Approval received from the University of Toronto research ethics board and other participating sites in the summer of 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Postpartum Depression

Intervention

Mothers allocated to the peer support group will have access to all of the standard community postpartum services in addition to receiving 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 will be initiated within 48 to 72 hours of trial randomisation and then as frequently as the dyad deems necessary.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Postpartum Depression (PPD), as diagnosed by the Structured Clinical Interview (SCID-I) for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) at 12 weeks postpartum.

Secondary outcome measures

1. PPD, as diagnosed by the SCID-I, at 24 weeks postpartum
2. Depressive symptomatology, as measured by the EPDS, at 12 and 24 weeks postpartum
3. Anxiety, as measured by the Spielberger State-Anxiety Inventory, at 12 and 24 weeks postpartum
4. Loneliness, as measured by the short-version University of California, Los Angeles (UCLA) Loneliness Scale, at 12 and 24 weeks postpartum
5. Health Service Utilisation, as measured by a modified version of the Health Service Utilisation and Cost of Care Questionnaire, at 12 and 24 weeks postpartum

Overall trial start date

01/07/2004

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Live birth
2. Aged 18 - 49 years old, female
2. Discharged from hospital
3. Less than two weeks postpartum
4. Scored more than nine on the EPDS
5. Availability of a peer volunteer who speaks the potential participant's language

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

700

Participant exclusion criteria

1. Infant not discharged home with mother
2. Current use of anti-depressant or anti-psychotic medication

A prior self-reported mental illness, including prior PPD, will not be an exclusion criterion.

Recruitment start date

01/07/2004

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Canada

Trial participating centre

University of Toronto
Toronto, ON
M5T 1P8
Canada

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

27 King's College Circle
Toronto
Ontario
M5S 1A1
Canada
+1 416 978 2163
audrey.cheung@utoronto.ca

Sponsor type

University/education

Website

http://www.utoronto.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 66874)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19147637
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24742217

Publication citations

  1. Results

    Dennis CL, Hodnett E, Kenton L, Weston J, Zupancic J, Stewart DE, Kiss A, Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial., BMJ, 2009, 338, a3064.

  2. Results

    Dennis CL, The process of developing and implementing a telephone-based peer support program for postpartum depression: evidence from two randomized controlled trials, Trials, 2014, 15, 131, doi: 10.1186/1745-6215-15-131.

Additional files

Editorial Notes