Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial.
Antenatal depression
Low- and middle-income countries
Perinatal mental health; Ethiopia
Problem solving therapy
Psychological interventions
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
30 Jan 2021
30 Jan 2021
Historique:
received:
11
08
2020
accepted:
08
01
2021
entrez:
30
1
2021
pubmed:
31
1
2021
medline:
31
1
2021
Statut:
epublish
Résumé
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. Design: A randomised, controlled, feasibility trial and mixed method process evaluation. 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 10 Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks. enhanced usual care (EUC). 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. 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. 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. 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 .
Sections du résumé
BACKGROUND
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
METHODS
Design: A randomised, controlled, feasibility trial and mixed method process evaluation.
PARTICIPANTS
METHODS
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 10
INTERVENTION
METHODS
Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks.
CONTROL
METHODS
enhanced usual care (EUC).
SAMPLE SIZE
METHODS
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
RESULTS
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
CONCLUSIONS
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
BACKGROUND
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 .
Identifiants
pubmed: 33514447
doi: 10.1186/s40814-021-00773-8
pii: 10.1186/s40814-021-00773-8
pmc: PMC7846490
doi:
Types de publication
Journal Article
Langues
eng
Pagination
35Subventions
Organisme : Medical Research Council
ID : MR/M014290/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/R018464/1
Pays : United Kingdom
Organisme : Welcome Trust through Deltas Africa Initiative
ID : DEL-15-01
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