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.: PACTR202002513482084 Date registered: 13/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intimate partner violence (IPV)-focused problem solving therapy (PST) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: randomised feasibility trial
Official scientific title Intimate partner violence (IPV)-focused problem solving therapy (PST) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: randomised feasibility trial
Brief summary describing the background and objectives of the trial Lifetime prevalence of intimate partner violence (IPV) exposure among women in rural Ethiopia is 72%; it is most prevalent during pregnancy. Adversely affecting women’s physical and mental health, IPV also increases the risk of child mortality associated with maternal depression, making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal common mental disorders (depression and anxiety) to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised feasibility trial and process evaluation will compare brief problem-solving therapy (PST) adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care, to determine the feasibility and acceptability of a future, fully-powered randomised controlled trial.
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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 06/04/2020
Actual trial start date
Anticipated date of last follow up 07/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Problem solving therapy adapted for women experiencing intimate partner violence 4x fortnightly sessions Up to 1 hour Brief problem-solving therapy adapted for the Ethiopian context, further adapted for women experiencing intimate partner violence. Sessions will comprise psychoeducation, problem categorisation, problem solving skills and reviewing of homework tasks. 25
Control Group Enhanced usual care Once 10 minutes A single contact providing information about sources of support. 25 Active-Treatment of Control Group
Experimental Group Standard Problem solving therapy 4x fortnightly sessions Up to 1 hour Brief problem-solving therapy adapted for the Ethiopian context, to address perinatal depression. Sessions will comprise psychoeducation, problem categorisation, problem solving skills and reviewing of homework tasks. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Amharic-speaking women. • Aged 16 years or over. • Between 12 and 34 weeks’ gestation of pregnancy. • Intending to reside in the study area for the duration of the study. • Scoring 5 or more on PHQ-9, with functional impairment (10th question). • Reporting IPV in the past year (in a current or previous relationship), during screening. • Consenting to participate, including to attend four sessions of PST-IPV or PST, if randomised to a treatment arm. Women who: • Are acutely unwell. • Require emergency treatment. • Are identified by the ANC provider during pre-screening as having possible psychotic symptoms. • Are unable to understand the interview (e.g. diagnosed with severe intellectual disability or dementia, or unable to speak Amharic). • Expect to move away from the study area before the study is completed, will be excluded from this study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 44 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 25/01/2019 Psychiatry Nursing and Midwifery subcommittee of Kings College London Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
5.9 Waterloo Bridge Wing, Waterloo Road London 111111 United Kingdom
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 22/07/2019 Addis Ababa University College of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
College of Health Sciences Addis Ababa 111111 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression symptoms on PHQ9 Baseline and 9 weeks followup
Secondary Outcome Past month intimate partner violence Baseline and 9 weeks followup
Secondary Outcome Trauma symptoms on PCL-5 Baseline and 9 weeks followup
Secondary Outcome Anxiety symptoms on GAD7 Baseline and 9 weeks followup
Secondary Outcome Disability on WHODAS 2.0 Baseline and 9 weeks followup
Secondary Outcome Attitudes towards gender roles on WHO Attitudes Towards Gender Roles questionnaire Baseline and 9 week followup
Secondary Outcome Self-efficacy on adapted Amharic self-efficacy scale Baseline and 9 week followup
Secondary Outcome Mastery on Amharic multicultural mastery scale Baseline and 9 weeks followup
Secondary Outcome Perceived social support on Oslo social support scale Baseline and 9 weeks followup
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Ababa University College of Health Sciences Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health Research NIHR London United Kingdom
Kings College London Waterloo Road London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University College of Health Sciences Addis Ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr Tesera Bitew College of Health Sciences, Addis Ababa University Addis Ababa Ethiopia
Professor Katherine Sorsdahl Alan J Flisher Centre for Publilc Mental Health, Department of Psychiatry and Mental Health, University of Cape Town Cape Town South Africa
Professor Bronywyn Myers Alcohol Tobacco and Other Drug Use Research Unit, South African Medical Research Council, South Africa and Department of Psychiatry and Mental Health, University of Cape Town Cape Town South Africa
Associate Professor Simone Honikman Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town Cape Town South Africa
Dr Girmay Medhin Aklilu-Lemma Institute of Pathobiology, Addis Ababa University Addis Ababa Ethiopia
Dr Negussie Deyessa College of Health Sciences, Addis Ababa University Addis Ababa Ethiopia
Professor Nick Sevdalis Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, Kings College London London United Kingdom
Associate Professor Wietse A Tol Bloomberg School of Public Health, Johns Hopkins University Baltimore United States of America
Professor Louise Howard Section of Womens Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, Kings College London London United Kingdom
Dr Charlotte Hanlon Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, Kings College London and World Health Organization Collaborating Centre for Mental Health Research and Capacity-Building, Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roxanne Keynejad roxanne.1.keynejad@kcl.ac.uk +442078480047 PO31 David Goldberg Building, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park
City Postal code Country Position/Affiliation
London United Kingdom Clinical Research Training Fellow
Role Name Email Phone Street address
Public Enquiries Roxanne Keynejad roxanne.1.keynejad@kcl.ac.uk +442078480047 As above
City Postal code Country Position/Affiliation
London United Kingdom Clinical Research Training Fellow
Role Name Email Phone Street address
Scientific Enquiries Roxanne Keynejad roxanne.1.keynejad@kcl.ac.uk +442078480047 As above
City Postal code Country Position/Affiliation
London United Kingdom Clinical Research Training Fellow
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 URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 31/01/2020 Alternate email for PhD supervisor added. Principal Investigator, Roxanne, Keynejad, Dr., roxanne.1.keynejad@kcl.ac.uk, , +442078480047, PO31 David Goldberg Building, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park, London, , United Kingdom, Clinical Research Training Fellow Principal Investigator, Roxanne, Keynejad, Dr., roxanne.1.keynejad@kcl.ac.uk, charlotte.hanlon@kcl.ac.uk, +442078480047, PO31 David Goldberg Building, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park, London, , United Kingdom, Clinical Research Training Fellow
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 31/01/2020 Alternate email for PhD supervisor added. Public Enquiries, Roxanne , Keynejad, Dr., roxanne.1.keynejad@kcl.ac.uk, , +442078480047, As above, London, , United Kingdom, Clinical Research Training Fellow Public Enquiries, Roxanne , Keynejad, Dr., roxanne.1.keynejad@kcl.ac.uk, charlotte.hanlon@kcl.ac.uk, +442078480047, As above, London, , United Kingdom, Clinical Research Training Fellow
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 31/01/2020 Alternate email for PhD supervisor added. Scientific Enquiries, Roxanne, Keynejad, Dr., roxanne.1.keynejad@kcl.ac.uk, , +442078480047, As above, London, , United Kingdom, Clinical Research Training Fellow Scientific Enquiries, Roxanne, Keynejad, Dr., roxanne.1.keynejad@kcl.ac.uk, charlotte.hanlon@kcl.ac.uk, +442078480047, As above, London, , United Kingdom, Clinical Research Training Fellow
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 31/01/2020 Additional information requested by PACTR. No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 31/01/2020 Additional information requested by PACTR. 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 31/01/2020 Additional information requested by PACTR. 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 31/01/2020 Additional information requested by PACTR. 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 31/01/2020 Additional information requested by PACTR. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report