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: pactr.samrc.ac.za
Trial no.: PACTR201303000485383 Date of Approval: 16/01/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Infections and Infestations,Mental and Behavioural Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 16/08/2006
Actual trial start date 30/08/2006
Anticipated date of last follow up 27/06/2007
Actual Last follow-up date 14/03/2007
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 38
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
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-Treatment of Control Group
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 Age Category Minimum age Maximum 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 Year(s) 55 Year(s) 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 22/06/2006 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 Street address
Principal Investigator Dixon Chibanda dichi@zol.co.zw 263712204107 24 Frank Johnson, Eastlea
City Postal code Country Position/Affiliation
Harare CY 105 Zimbabwe Psychiatrist
Role Name Email Phone Street address
Public Enquiries Walter Mangezi wmangezi@yahoo.co.uk 00263712606560 Mzowe street
City Postal code Country Position/Affiliation
Harare CY 23 Zimbabwe Psychiatrist
Role Name Email Phone Street address
Scientific Enquiries Simbarashe Rusakaniko srusakaniko@gmail.com 2634791445 Mazowe street
City Postal code Country Position/Affiliation
Harare CY 23 Zimbabwe Professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information