Browsing by Subject "Psychological interventions"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Open Access
    Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial
    (2021-01-30) Bitew, Tesera; Keynejad, Roxanne; Myers, Bronwyn; Honikman, Simone; Medhin, Girmay; Girma, Fikirte; Howard, Louise; Sorsdahl, Katherine; Hanlon, Charlotte
    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 .
  • Thumbnail Image
    Item
    Open Access
    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: protocol for a randomised controlled feasibility trial
    (2020-06-01) Keynejad, Roxanne C; Bitew, Tesera; Sorsdahl, Katherine; Myers, Bronwyn; Honikman, Simone; Medhin, Girmay; Deyessa, Negussie; Sevdalis, Nick; Tol, Wietse A; Howard, Louise; Hanlon, Charlotte
    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.