Effectiveness of peer support for the prevention of postpartum depression

ISRCTN	ISRCTN68337727
DOI	https://doi.org/10.1186/ISRCTN68337727
ClinicalTrials.gov (NCT)	NCT00604604
Protocol serial number	MCT 66874
Sponsor	University of Toronto (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 66874)

Submission date: 19/07/2004
Registration date: 22/07/2004
Last edited: 20/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Cindy-Lee Dennis
Scientific

University of Toronto
Lawrence S. Bloomberg Faculty of Nursing
155 College Street, Suite 130
Toronto, ON
M5T 1P8
Canada

Phone	+1 416 946 8608
Email	cindylee.dennis@utoronto.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial to evaluate the effectiveness of peer (mother-to-mother) support for the prevention of postpartum depression
Study objectives	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(s)	Approval received from the University of Toronto research ethics board and other participating sites in the summer of 2004.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	700
Key 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
Key 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.
Date of first enrolment	01/07/2004
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Canada

Study participating centre

University of Toronto

Toronto, ON
M5T 1P8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2009		Yes	No
Results article	results	17/04/2014		Yes	No