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.: PACTR202008712234907 Date of Approval: 18/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia
Official scientific title Feasibility of brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled trial
Brief summary describing the background and objectives of the trial Depression in the antenatal period affects approximately 16% of women in low- and middle-income countries (LMICs), with adverse impacts on the woman and the unborn child. Improved detection and treatment of antenatal depression is hypothesized to improve maternal and perinatal outcomes. The aims of this study are: (1) to examine the feasibility of procedures for a future fully powered efficacy trial of contextually adapted brief Problem Solving Therapy (PST) for antenatal depression in rural Ethiopia, and (2) to investigate the acceptability, fidelity and feasibility of delivery of PST in routine antenatal care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2020
Actual trial start date
Anticipated date of last follow up 14/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Brief Problem Solving Therapy for women with antenatal depressinon A 45 minutes, four Problems Solving sessions over a maximum of 8 weeks A maximum of 8 weeks Problem Solving Therapy (PST) was considered a good fit with the problem-oriented nature of presentations of psycho-social distress in primary care, the association of perinatal depression with maladaptive problem-solving and poor coping and the simplicity of the therapeutic model for a low literacy population. PST that focuses on improving a person’s ability to cope with problems and stressful life experiences). In meta analyses, PST has been found to be as efficacious for treatment of depression as other psychological therapies in comparison to no treatment. There is evidence of effectiveness and acceptability of PST in clinical populations with relatively low levels of education. However, there has been limited use of PST for perinatal depression in rural, low-income country settings. 2
Control Group Enhanced usual care usual antenatal care and information about general support for a maximum of 8 weeks The Federal Ministry of Health in Ethiopia has prepared evidence-aligned guidelines on how to care for mental health problems in primary health care and maternal care settings. According to the guideline, primary healthcare staff are expected to detect mental health problems and to provide basic mental healthcare (non-specific psychosocial care for all and supervised prescription of antidepressant medication depending on severity). All healthcare providers participating in the trial will have been trained in the World Health Organisation’s mhGAP for a minimum of five days, as per the mental health scale-up plans of the Federal Ministry of Health. women in EUC group will also receive information about general sources of support. 2 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) endorsing elevated and disabling depression symptoms (scoring 5 or more on the locally validated Patient Health Questionnaire (PHQ-9) (45) and endorse impaired functioning on the 10th PHQ-9 item); (2) being between 12 and 34 weeks gestation; (3) aged 16 years and above, as this is the age at which married adolescent women become legally autonomous in Ethiopia; (4) are planning to live in the study area for at least six months; (5) speak Amharic (the official regional language). (1) present with acute medical illness or evidence of severe mental illness; or (2) other comorbid medical conditions such as hypertension or renal disease or diabetes; (3) endorse the 9th item of the PHQ-9 indicating risk of suicide and scoring more than 17 on the Mini International Neuropsychiatric Interview (MINI) (4) require emergency treatment; (5) have a condition that impairs their capacity to understand the interview (e.g. diagnosed with severe intellectual disability or dementia). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 45 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 10/07/2019 Addis Ababa University College of Health Science IRB
Ethics Committee Address
Street address City Postal code Country
Addis Ababa University, college of Health Sciences, IRB, Addis Ababa Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean change in PHQ-9 score using locally validated Amharic version of the PHQ-9. PHQ-9 is a DSM based screening tool for depression that is widely used in Low and middle income countries. Its good psychometric characteristic also make most preferable in these settings. assessed at nine weeks from recruitment and 4-6 weeks after after childbirth
Secondary Outcome functional status (Change in WHODAS score) 9 weeks after intervention and 4-6 weeks after childbirth
Secondary Outcome anxiety as assessed by using GAD-7 9 weeks after recruitment and weeks after childbirth
Secondary Outcome intimate partner violence as assessed by WHO multi-country study questions assessed at nine week follow up and weeks after childbirth
Secondary Outcome self-reported information on delivery setting, prolonged labour, sepsis, unsafe abortion 4-6 weeks after childbirth
Secondary Outcome perinatal mortality (stillbirth and neonatal mortality) 4-6 weeks after childbirth
Secondary Outcome time of onset of breast-feeding 4-6 weeks after childbirth
Secondary Outcome child health (maternal report of diarrhoea, fever and refusal to breast feed) 4-6 weeks after childbirth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bui District Hospital Southern Nationalities and Nations Peoples Region, Guragie Zone, Sodo District Bui Ethiopia
Kibet Primary Health Center Southeren Nations, Nationalities and peoples region, Gurage Zone Worabe Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Welcome Trust through Deltas Africa Initiative AESA Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University Addis Ababa Addis ABaba 0178 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Roxanne Keynejad Kings College London London United Kingdom
Bronwyn Myers Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council and Department of Psychiatry Cape Town South Africa
Simone Honikman University of Cape Town Cape Town South Africa
Girmay Medhin Aklilu Lemma Institute of Pathobiology, Addis Ababa University Addis Ababa Ethiopia
Fikirte Girma Addis Ababa University Addis Ababa Ethiopia
Louise Howard Kings College London London United Kingdom
Katherine Sorsdahl University of Cape Town Cape Town South Africa
Charlotte Hanlon University of Cape Town Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tesera Bitew tesera2016@gmail.com +251911173656 Amhara Regional State, Debre Markos University, Insititue of Educational and Behavioral Sciences, Department of Psychology, Debre Markos
City Postal code Country Position/Affiliation
Debre Markos Ethiopia Assistant Professor
Role Name Email Phone Street address
Public Enquiries Charlotte Hanlon charlotte.hanlon@kcl.ac.uk +251912803374 Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Associate Professor Addis Ababa University
Role Name Email Phone Street address
Scientific Enquiries Eshcolewyne Fekadu escochgt@gmail.com +251911836322 Addis Ababa University, college of health Sciences, Department of Psychiatry, Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Trial Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The minimum dataset used to calculate the study findings will be included with the study’s resultant outcome-reporting manuscript as a supplementary file. Additional datasets generated during this study will be available from the corresponding author upon reasonable request. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The minimum dataset used to calculate the study findings will be included with the study’s resultant outcome-reporting manuscript as a supplementary file. Additional datasets generated during this study will be available from the corresponding author upon reasonable request. Researchers may request access to study data from the principal investigator for secondary data analysis for relevant research purposes by email correspondence. Decisions about data sharing will be made by the principal investigator in conjunction with PhD supervisors. Decisions will be based on the research justification for the request, subject to safe data sharing and storage processes.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 18/08/2020 it is psychological intervention for antenatal depression Other Interventions Treatment: Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 18/08/2020 some delay may be expected depending on COVIV-19 emergency state 14 Sep 2020 01 Oct 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 18/08/2020 some delay may be expected depending on COVIV-19 emergency state 31 Dec 2020 14 Jan 2021
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 18/08/2020 IPD statement was nor reported earlier and requested to include No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/08/2020 requested to include The minimum dataset used to calculate the study findings will be included with the study’s resultant outcome-reporting manuscript as a supplementary file. Additional datasets generated during this study will be available from the corresponding author upon reasonable request.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 18/08/2020 requested to include The minimum dataset used to calculate the study findings will be included with the study’s resultant outcome-reporting manuscript as a supplementary file. Additional datasets generated during this study will be available from the corresponding author upon reasonable request.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 18/08/2020 requested to include Researchers may request access to study data from the principal investigator for secondary data analysis for relevant research purposes by email correspondence. Decisions about data sharing will be made by the principal investigator in conjunction with PhD supervisors. Decisions will be based on the research justification for the request, subject to safe data sharing and storage processes.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 18/08/2020 requested to include Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report