Katherine Sorsdahl1, Charlotte Hanlon2,3,4, Tesera Bitew5,6, Roxanne Keynejad7, Bronwyn Myers8,9, Simone Honikman10, Girmay Medhin11, Fikirte Girma2, Louise Howard7. 1. Department of Psychiatry and Mental Health, Alan J. Fisher Centre for Public Mental Health, University of Cape Town, Cape Town, South Africa. 2. Department of Psychiatry, College of Health Sciences, School of Medicine, Addis Ababa University, Addis Ababa, Ethiopia. 3. Health Service and Population Research Department, Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. 4. Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. 5. Department of Psychology, Institute of Educational and Behavioural Sciences, Debre Markos University, Debre Markos, Ethiopia. tesera2016@gmail.com. 6. Department of Psychiatry, College of Health Sciences, School of Medicine, Addis Ababa University, Addis Ababa, Ethiopia. tesera2016@gmail.com. 7. Institute of Psychiatry, Psychology & Neuroscience, Section of Women's Mental Health, King's College London, London, UK. 8. Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Cape Town, South Africa. 9. Department of Psychiatry & Mental Health, University of Cape Town, Cape Town, South Africa. 10. Department of Psychiatry and Mental Health, Perinatal Mental Health Project, University of Cape Town, Cape Town, South Africa. 11. Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.
Abstract
BACKGROUND: Despite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. 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. METHODS: Design: A randomised, controlled, feasibility trial and mixed method process evaluation. PARTICIPANTS: Consecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: (1) disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) scoreof five or more and positive for the 10th disability item); (2) gestational age 12-34 weeks; (3) aged 16 years and above; (4) planning to live in the study area for at least 6 months; (5) no severe medical or psychiatric conditions. INTERVENTION: Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks. CONTROL: enhanced usual care (EUC). SAMPLE SIZE: n = 50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed 9 weeks after recruitment. SECONDARY OUTCOMES: anxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4-6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording of randomly selected sessions and in-depth interviews with purposively selected participants, healthcare providers and supervisors will be analysed thematically to explore the acceptability and feasibility of the trial procedures and fidelity of the delivery of PST. DISCUSSION: The findings of the study will be used to inform the design of a fully powered efficacy trial of brief PST for antenatal depression in routine care in rural Ethiopia. TRIAL REGISTRATION: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 .
RCT Entities:
BACKGROUND: Despite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. 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. METHODS: Design: A randomised, controlled, feasibility trial and mixed method process evaluation. PARTICIPANTS: Consecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: (1) disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) score of five or more and positive for the 10th disability item); (2) gestational age 12-34 weeks; (3) aged 16 years and above; (4) planning to live in the study area for at least 6 months; (5) no severe medical or psychiatric conditions. INTERVENTION: Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks. CONTROL: enhanced usual care (EUC). SAMPLE SIZE: n = 50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed 9 weeks after recruitment. SECONDARY OUTCOMES: anxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4-6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording of randomly selected sessions and in-depth interviews with purposively selected participants, healthcare providers and supervisors will be analysed thematically to explore the acceptability and feasibility of the trial procedures and fidelity of the delivery of PST. DISCUSSION: The findings of the study will be used to inform the design of a fully powered efficacy trial of brief PST for antenatal depression in routine care in rural Ethiopia. TRIAL REGISTRATION: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 .
Entities:
Keywords:
Antenatal depression; Low- and middle-income countries; Perinatal mental health; Ethiopia; Problem solving therapy; Psychological interventions
Authors: Nancy K Grote; Jeffrey A Bridge; Amelia R Gavin; Jennifer L Melville; Satish Iyengar; Wayne J Katon Journal: Arch Gen Psychiatry Date: 2010-10
Authors: Wayne J Katon; Joan E Russo; Jennifer L Melville; Jodie G Katon; Amelia R Gavin Journal: Gen Hosp Psychiatry Date: 2011-11-03 Impact factor: 3.238
Authors: Alan Stein; Rebecca M Pearson; Sherryl H Goodman; Elizabeth Rapa; Atif Rahman; Meaghan McCallum; Louise M Howard; Carmine M Pariante Journal: Lancet Date: 2014-11-14 Impact factor: 79.321