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Postpartum Depression Interpersonal Psychotherapy Trial
ISRCTN ISRCTN88987377
DOI 10.1186/ISRCTN88987377
ClinicalTrials.gov identifier
EudraCT number
Public title Postpartum Depression Interpersonal Psychotherapy Trial
Scientific title A randomised controlled trial to evaluate the effectiveness of telephone-based interpersonal psychotherapy for the treatment of postpartum depression
Acronym N/A
Serial number at source MCT-82332
Study hypothesis As of 12/06/2009 this record has been updated to include amendments to the protocol. These amendments can be found in the relevant field under the above update date. All protocol changes have been approved by the relevant ethics boards.

Primary question:
What is the effect of telephone-based Interpersonal Psychotherapy (IPT) by trained nurses on Postpartum Depression (PPD) at 12 weeks post-randomisation (i.e., immediately post-treatment for mothers in the intervention group)?

Amended as of 12/06/2009:
The following secondary question has been amended:
4. Attachment at 12, 24, and 36 weeks post-randomisation?
The following secondary question has been added:
6. Relationship quality and adjustment at 12, 24, and 36 weeks post-randomisation?

Secondary questions:
What is the effect of telephone-based IPT by trained nurses on:
1. PPD at 24 and 36 weeks post-randomisation (i.e., 12 and 24 weeks post-treatment for mothers in the intervention group)?
2. Depressive symptomatology at 12, 24, and 36 weeks post-randomisation?
3. Anxiety at 12, 24, and 36 weeks post-randomisation?
4. Social functioning at 12, 24, and 36 weeks post-randomisation?
5. Health service utilisation from randomisation to 36 weeks post-randomisation?

Other research questions:
1. What are the cost implications of IPT versus usual care, from a societal perspective?
2. What are mothersí evaluations of their IPT experience?
3. What are nursesí evaluations of their experience in providing IPT?
4. What are nursesí reports of the type and intensity of their IPT activities?

As of 04/10/2011, the anticipated end date for this trial has been extended from 30/09/2010 to 28/02/2013.
Lay summary Lay summary under review 2
Ethics approval Approval received from:
1. Health Sciences 1 Research Ethics Board of the University of Toronto (Canada) on the 13 July 2006 (ref: 17788)
2. The Huron Country Health Unit (Canada) on the 12th October, 2006

Added on 12/06/2009:
3. Health Sciences 1 Research Ethics Board of the University of Toronto (Canada) renewal granted on the 8th August 2007, Expiry: July 12, 2008 (ref: 20766)
4. Health Sciences 1 Research Ethics Board of the University of Toronto (Canada) renewal granted on the 15th August 2008, Expiry: July 12, 2009 (ref: 22629)
Study design Multicentre, two-arm, randomised parallel trial with study investigator, caregiver, outcome assessor, and data analyst blinding
Countries of recruitment Canada
Disease/condition/study domain Postpartum depression
Participants - inclusion criteria 1. Live birth
2. Infant discharged from hospital
3. Mother between two and 24 weeks postpartum
4. Clinical diagnosis of major depression using the Structured Clinical Interview for Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV)
5. Understands spoken English
Participants - exclusion criteria Amended as of 12/06/2009:
The following point was amended to:
4. Chronic depression (episode length greater than 2 years)
The following point was added:
5. Current or past manic depression

Initial information at time of registration:
1. Current use of antidepressant medication
2. Currently receiving any form of psychotherapy administered by a trained professional
3. Active suicidal or self-harm thoughts
4. Chronic depression (episode length greater than 2.5 years)
Anticipated start date 01/09/2007
Anticipated end date 28/02/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 240
Interventions Amended as of 12/06/2009:
Interpersonal psychotherapy: one-hour session of telephone-based interpersonal psychotherapy every week for 12 weeks (i.e., or a maximum of 16 sessions for up to 16 weeks per participant)
Standard care: what is usually provided by the health region for mothers identified with depressive symptomatology.

Initial information at time of registration:
Interpersonal psychotherapy: one-hour session of telephone-based interpersonal psychotherapy every week for 12 weeks beginning within 48 to 72 hours of trial randomisation.
Standard care: what is usually provided by the health region for mothers identified with depressive symptomatology.

Contact for public queries:
Melissa Jovellanos
University of Toronto (Canada)
Lawrence S. Bloomberg Faculty of Nursing
130-155 College Street
Toronto, ON
M5T 1P8
Canada
Tel: +1 416 946 0929
Fax: +1 416 946 8681
Email: melissa.jovellanos@utoronto.ca
Primary outcome measure(s) Postpartum depression: 12 weeks post-randomisation (immediately post-treatment for mothers in the intervention group).
Secondary outcome measure(s) Amended as of 12/06/2009:
The following point was amended to:
4. Attachment measured with the Experiences in Close Relationships-Revised (self-report measure): 12, 24, and 36 weeks post-randomisation
The following point was added:
6. Relationship quality and adjustment with the Dyadic Adjustment Scale (self-report measure): 12, 24, and 36 weeks post-randomisation

Initial information at time of registration:
1. Postpartum depression (clinical diagnostic interview): 24 and 36 weeks post-randomisation (i.e., 12 and 24 weeks post-treatment for mothers in the intervention group
2. Depressive symptomatology (self-report measure): 12, 24, and 36 weeks post-randomisation
3. Anxiety measured with the Spielberger State-Anxiety Inventory (self report measure): 12, 24, and 36 weeks post-randomisation
4. Social functioning measured with the Social Adjustment Scale-Self Report (self report measure): 12, 24, and 36 weeks post-randomisation
5. Health service utilisation measured with a slightly modified version of the Health Service Utilisation and Cost of Care Questionnaire (self-report measure): from randomisation to 36 weeks post-randomisation
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82332)
Trial website
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22515528
Contact name Dr  Cindy-Lee Elizabeth  Dennis
  Address University of Toronto (Canada)
Lawrence S. Bloomberg Faculty of Nursing
130-155 College Street
Toronto
  City/town Ontario
  Zip/Postcode M5T 1P8
  Country Canada
  Tel +1 416 946 8608
  Fax +1 416 978 8222
  Email cindylee.dennis@utoronto.ca
Sponsor University of Toronto (Canada)
  Address 27 King's College Circle
Toronto
  City/town Ontario
  Zip/Postcode M5S 1A1
  Country Canada
  Tel +1 416 978 2163
  Fax +1 416 971 2010
  Email audrey.cheung@utoronto.ca
  Sponsor website: http://www.utoronto.ca/
Date applied 30/03/2007
Last edited 07/11/2012
Date ISRCTN assigned 30/03/2007
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