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.: PACTR201410000876178 Date of Approval: 25/08/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Friendship Bench Project
Official scientific title A cluster randomised controlled trial of a brief psychological intervention for common mental disorders delivered by lay health workers
Brief summary describing the background and objectives of the trial Common mental disorders (CMD) are highly prevalant among people utilizing primary health care facilities in Zimbabwe. There is a big treatment gap for CMD in Zimbabwe. In 2011 we successfuly piloted a brief psychological intervention based on problem solving therapy in harare, Zimbabwe. However, this was not a controlled trial. This study will test efficacy and cost effectiveness of this brief psychological intervention delivered by lay health workers over a 6 month period. The intervention will consist of 6 sessions of problem solving therapy delivered over a 4-6 week period followed by a peer support group delivered over an 8 week period. The study will be carried out in 24 clinics (clusters).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Common mental disorders,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/09/2014
Actual trial start date 01/09/2014
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 30/06/2015
Anticipated target sample size (number of participants) 580
Actual target sample size (number of participants) 573
Recruitment status Completed
Publication URL http://ijmhs.biomedcentral.com/articles/10.1186/s13033-015-0013-y
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Restricted randomisation (cluster randomised trial) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Problem solving therapy 4-6 sessions 4-6 weeks brief psychological intervention based on problem solving and peer group support 24 Active-Treatment of Control Group
Control Group Enhanced usual care As frequent as needed 6 weeks with additional follow up at clinic level if needed Psycho-education on common mental disorders, what causes them and the kind of assistance they can get from the local clinic and tertiary facilities 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age above 18, residing in the area, attending local clinic, SSQ score of 9 or above pregnancy in last trimester or post delivery of less than 3 months. Physically unwell according to clinic nurse in-charge 18 Year(s) 100 Year(s) Both
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 30/06/2014 Medical research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazoe street Harare Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SSQ at 6 months 6 months
Secondary Outcome PHQ-9 at 6 months (binary) 6 months
Secondary Outcome GAD-7 6 month
Secondary Outcome WHO-DAS 6 months
Secondary Outcome EQ-5D 6 months
Secondary Outcome PHQ-9 symptoms 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Belvedere Clinic (Control) Belvedere Suburb Harare Zimbabwe
Kuwadzana Poly (Intervention) Kuwadzana Suburb Harare Zimbabwe
Glen View Poly (Intervention) Glen View Suburb Harare Zimbabwe
Glen Norah Satellite (Intervention) Glen Norah Suburb Harare Zimbabwe
Glen View Satellite (Intervention) Glen View Suburb Harare Zimbabwe
WaterFalls satellite (Intervention) WaterFalls Suburb Harare Zimbabwe
Warren Park ( Intervention) Warren Park Suburb Harare Zimbabwe
Hatfield (Control) Hatfield Suburb Harare Zimbabwe
Marlborough (Control) Marlborough Suburb Harare Zimbabwe
Mufakose Poly (Control) Mufakose Suburb Harare Zimbabwe
Rutsanana Poly (Control) Rutsanana Suburb Harare Zimbabwe
Mount Pleasant (Control) Mount Pleasant Suburb Harare Zimbabwe
Budiriro (Control) Budiriro Suburb Harare Zimbabwe
Western Triangle (Intervention) Western Triangle Suburb Harare Zimbabwe
High fields (Control) Highfields Suburb Harare Zimbabwe
Dzivaresekwa Poly (Control) Dzivaresekwa Suburb Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada 101 College Street Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zimbabwe Aids Project tongogarar Harare C678 Zimbabwe University
COLLABORATORS
Name Street address City Postal code Country
Melanie Abas Institute of Psychiatry, De Crespigny Park London SE5 8AF United Kingdom
Helen Weiss LSHTM, Keppel Street London WC1E 7HT United Kingdom
Ricardo Araya LSHTM, Keppel Street London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dixon Chibanda dichi@zol.co.zw +263712204107 24 Frank Johnson Ave
City Postal code Country Position/Affiliation
Harare Zimbabwe Principle investigator
Role Name Email Phone Street address
Public Enquiries Epiphania Munetsi emunetsi2005@yahoo.co.uk 263772376205 92 Prince Edward Street
City Postal code Country Position/Affiliation
Harare CY105 Causeway Zimbabwe Public Enquiries/ Project Coordinator
Role Name Email Phone Street address
Scientific Enquiries Dixon Chibanda dichi@zol.co.zw +263712204107 24 Frank Jhonson Ave
City Postal code Country Position/Affiliation
Harare Zimbabwe Principle Investigator
REPORTING
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