Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial

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) 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.

Psychoeducation as an active ingredient for interventions for perinatal depression and anxiety in youth: a mixed-method systematic literature review and lived experience synthesis

“…where non-mental-health specialists deliver psychological interventions) may be impeded in situations where busy health workers have to take on extra tasks, training and supervision alongside their normal roles. 63 In line with the association between therapeutic alliance and mental health outcomes in young people, 64 a supportive, kind and non-judgemental therapist was identified as being a key facilitator in the delivery of psychoeducational interventions. Although there has been substantial attention given to the potential public health benefits of digital interventions and the use of self-directed (online) modes to reduce human resources and increase access to mental health at a wider population level (although none of our included studies looked at digital delivery), research has shown that some degree of human facilitation tends to increase engagement with and adherence to digital interventions.…”

Adapting an intervention of brief problem-solving therapy to improve the health of women with antenatal depressive symptoms in primary healthcare in rural Ethiopia

“…Accelerated delivery meant that each trainee delivered the intervention to one pregnant woman with depressive symptoms over a 2-week period. Barriers and challenges to the delivery of the intervention were noted, and PHC staff were approached to provide feedback and recommendations on the intervention content and delivery through qualitative methods as reported in the trial protocol [48]. Although the COVID-19 pandemic delayed the commencement of training, the course itself was designed to adhere strictly to the Ministry of Health guidelines.…”

“…This was due to concerns that PHC workers may otherwise seek to problem-solve on women's behalf. The need to emphasise this point in fidelity checks, and supervision was noted and included in the trial protocol [48].…”

“…This intervention adaptation document was part of the feasibility RCT protocol [48] (Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https:// pactr. samrc.…”

Impact of the COVID-19 pandemic on mental health care and people with mental health conditions in Ethiopia: the MASC mixed-methods study

“…The new Ethiopian Primary Healthcare Clinical Guidelines include horizontally integrated mental health care and offer potential to support scale-up but are not fully implemented (26). Efforts to expand access to psychosocial care for people with mental health conditions are also underway but have not been taken to scale (27)(28)(29)(30).…”