TY - JOUR
T1 - Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia
T2 - Protocol for a randomised controlled feasibility trial
AU - Keynejad, Roxanne C.
AU - Bitew, Tesera
AU - Sorsdahl, Katherine
AU - Myers, Bronwyn
AU - Honikman, Simone
AU - Medhin, Girmay
AU - Deyessa, Negussie
AU - Sevdalis, Nick
AU - Tol, Wietse A.
AU - Hanlon, Charlotte
AU - Hanlon, Charlotte
AU - Howard, Louise
N1 - Funding Information:
RCK, CH, LH and NS are supported by the National Institute of Health Research (NIHR) Global Health Research Unit on Health System Strengthening in sub-Saharan Africa (ASSET), King’s College London (GHRU 16/136/54) using UK aid from the UK Government. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. RCK is supported by a King’s Institute of Psychiatry, Psychology & Neuroscience Clinician Investigator Scholarship for her PhD. CH and KS receive additional support from AMARI as part of the DELTAS Africa Initiative (DEL-1501) funded by the Wellcome Trust. LH is in receipt of an NIHR Senior Investigator award. TB receives support from AMARI as part of the DELTAS Africa Initiative (DEL-1501) funded by the Wellcome Trust as part of his post-doctoral work. BM is supported through jointly funded research grant funding from the Department for International Development, the Economic and Social Research Council, and Wellcome Trust (MR/M014290/1; MR/M011464/1) as well as the South African Medical Research Council. SH is supported by research grant funding from Bill and Melinda Gates Foundation OPP1179252 through her contribution to the Kilkari Impact Evaluation Project in India. The research of NS is supported by the NIHR Applied Research Collaboration (ARC) South London at King’s College Hospital NHS Foundation Trust. NS is a member of King’s Improvement Science, which offers co-funding to the NIHR ARC South London and comprises a specialist team of improvement scientists and senior researchers based at King’s College London. Its work is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), Guy’s and St Thomas’ Charity and the Maudsley Charity. The research of NS is supported by the ASPIRES research programme in LMICs (Antibiotic use across Surgical Pathways—Investigating, Redesigning and Evaluating Systems), funded by the Economic and Social Research Council. RCK had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funders played no role in the study design, data collection, data analysis, data interpretation, or report writing.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Background: In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal 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 controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial. Methods: Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes. Discussion: Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings. Trial registration: Pan-African clinical trials registry: PACTR202002513482084. Prospectively registered on 13 December 2019.
AB - Background: In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal 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 controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial. Methods: Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes. Discussion: Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings. Trial registration: Pan-African clinical trials registry: PACTR202002513482084. Prospectively registered on 13 December 2019.
KW - Feasibility studies
KW - Global mental health
KW - Implementation research
KW - Intimate partner violence
KW - Low- and middle-income countries
KW - Perinatal mental health
KW - Pregnancy
KW - Psychological interventions
KW - Task sharing
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U2 - 10.1186/s13063-020-04331-0
DO - 10.1186/s13063-020-04331-0
M3 - Article
C2 - 32487250
AN - SCOPUS:85085910050
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 454
ER -