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.: PACTR202206723109626 Date of Approval: 21/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Improving detection of depression in primary care: an interventional feasibility study
Official scientific title Improving detection of depression in primary care: an interventional feasibility study
Brief summary describing the background and objectives of the trial Most people with depression are seen at primary care. While this offers a huge opportunity for care, poor detection is a major obstacle in both high- and low-income countries. There is an urgent need to develop interventions that to tackle this obstacle. The objective of the study is to assess the feasibility and potential impact of contextually developed intervention to improve detection of depression in primary care in Ethiopia.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) IDEAS
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 19/05/2021
Actual trial start date 19/05/2021
Anticipated date of last follow up 13/06/2021
Actual Last follow-up date 13/06/2021
Anticipated target sample size (number of participants) 2000
Actual target sample size (number of participants) 1659
Recruitment status Completed
Publication URL
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training adapted for depression 4 weeks Primary Health Workers received a training adapted for depression for two weeks(1 week theoretical and 1 week practical) 388
Experimental Group Training and screening 4 weeks Primary Health Workers received a training adapted for depression for two weeks(1 week theoretical and 1 week practical). In addition, screening with feedback was used. That is patients were screened using a 4 item screening instrument for depression by triage nurses and the result was given to the PHCWs. 407
Experimental Group training screening and patient awareness enhancement 4 weeks Primary Health Workers received a training adapted for depression for two weeks(1 week theoretical and 1 week practical).Screening with feedback was also used. That is patients were screened using a 4 item screening instrument for depression by triage nurses and the result was given to the PHCWs. Moreover, patient awareness raising was included here using information leaflets and patient education. 585
Control Group standard integrated mental healthcare 4 weeks Primary healthcare workers received the standard integrated mental healthcare training using the mhGAP intervention guide 279 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For Health facilities - Having high patient flow Health Care workers -Working in the outpatient department of selected facilities Patients - Aged 18 or above - Receive treatment in the outpatient units of the selected health facilities No specific criteria Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 08/03/2018 Addis Ababa University College of Health Science Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Zambia Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Detection rate 4 weeks
Secondary Outcome Acceptability, Feasibility and Appropriateness of the interventions 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bui Primary Hospital Bui Sodo Sodo Ethiopia
Kela Health center Kela Sodo Ethiopia
Tiya Health Center Tiya Sodo Ethiopia
Wila Wila Wedesha Wila Wila Sodo Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
United kingdom Medical Research Council 58 Victoria Embankment London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University Zambia Addis Ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abebaw Wassie Abebaw.fekadu@aau.edu.et +251912894975 Zambia street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Center leader CDT Africa Addis Ababa university
Role Name Email Phone Street address
Public Enquiries Rahel Haile richina156@gmail.com +251604352 Zambia
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Senior Clinical Trials Manager
Role Name Email Phone Street address
Scientific Enquiries Abebaw Wassie abebaw.fekadu@aau.edu.et +251812894975 Zambia
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Center leader CDT Africa Addis Ababa university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary of results will be shared. IPD will be shared upon request Clinical Study Report 2 years request to IPD is open and the principal investigator of the study will decide to whom to share the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information