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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201303000485383 Date registered: 2013/01/16
TRIAL DESCRIPTION
Public title Developing a screening tool for postnatal Depression in Zimbabwe
Official scientific title Validation of the Edinburgh Postnatal Depression Scale in Zimbabwe
Brief summary describing the background
and objectives of the trial
After validating the Edinburgh Postnatal depression scale EPDS) we screened mothers attending the six week postnatal clinic in Harare. mothers scoring above the cutoff score were enrolled after written consent was obtained, into either group problem solving therapy delivered by a trained peer counsel or enhanced usual care delivered by a clinic nurse. Outcome measure was the EPDS score after 6-8 weeks .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Treatment
Anticipated trial start date 2006-08-16
Actual trial start date 2006-08-30
Anticipated date of last follow up 2007-06-27
Actual date of last follow up 2007-03-14
Anticipated target sample size (number of participants) 48   
Actual target sample size (number of participants) 38   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
nil known Medical Research Council of Zimbabwe

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Single group: all participants receive same intervention throughout study Randomised randomization using computer generated random numbers sealed opaque envelopes Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group health education for mothers six sessions each session 45-60minutes Cognitive behaviour 17 Active
Experimental group Group Problem solving therapy 6 sessions 45 minutes per session cognitive behaviour therapy based 21

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
adult mothers aged over 16 attending local clinic for 6 week postnatal visit who reside in district and give written consent non-resident of district, refusal to give written consent, critically ill 16 Years 55 Years Female

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2006/06/22 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Mazoe Street Harare P.O.Box CY 573 Zimbabwe

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Edinburgh Postnatal Depression Scale score after 6-8 weeks At 6 weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chitungwiza Clinics Chitungwiza town Chitungwiza P.O.Chitungwiza tow Zimbabwe

FUNDING SOURCES
Name of source Street address City Postal code Country
Community Medicine department Mazoe street Harare CY 23 Zimbabwe

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Zimbabwe Mazoe Street Harare CY 23 Zimbabwe University

COLLABORATORS
Name Street address City Postal code Country
Walter Mangezi Mazoe Street Harare CY 23 Zimbabwe

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Prof Simbarashe Rusakaniko srusakaniko@gmail.com 2634791445
Street address City Postal code Country Position / Affiliation
Mazowe street Harare CY 23 Zimbabwe Professor
Role Name Email Phone Fax
Principal Investigator Dr Dixon Chibanda dichi@zol.co.zw 263712204107 2634703565
Street address City Postal code Country Position / Affiliation
24 Frank Johnson, Eastlea Harare CY 105 Zimbabwe Psychiatrist
Role Name Email Phone Fax
Public Enquiries Dr Walter Mangezi wmangezi@yahoo.co.uk 00263712606560
Street address City Postal code Country Position / Affiliation
Mzowe street Harare CY 23 Zimbabwe Psychiatrist