A nurse-delivered mental health intervention for obstetric fistula patients in Tanzania: results of a pilot randomized controlled trial

BACKGROUND: Obstetric fistula has severe psychological consequences, but no evidence-based interventions exist to improve mental health in this population. This pilot trial evaluated a psychological intervention for women receiving surgical care for obstetric fistula. METHODS: A parallel two-armed pilot RCT was conducted between 2014 and 2016. The intervention was six individual sessions, based on psychological theory and delivered by a nurse facilitator. The study was conducted at a tertiary hospital in Moshi, Tanzania. Women were eligible if they were over age 18 and admitted to the hospital for surgical repair of an obstetric fistula. Sixty participants were randomized to the intervention or standard of care. Surveys were completed at baseline, post-treatment (before discharge), and 3 months following discharge. Standardized scales measured depression, anxiety, traumatic stress, and self-esteem. Feasibility of an RCT was assessed by participation and retention. Feasibility and acceptability of the intervention were assessed by fidelity, attendance, and participant ratings. Potential efficacy was assessed by exploratory linear regression and clinical significance analysis. RESULTS: Eighty-five percent met criteria for mental health dysfunction at enrollment. All eligible patients enrolled, with retention 100% post and 73% at 3 months. Participants rated the intervention acceptable and beneficial. There were sharp and meaningful improvements in mental health outcomes over time, with no evidence of differences by condition. CONCLUSIONS: A nurse-delivered mental health intervention was feasible to implement as part of in-patient clinical care and regarded positively. Mental health treatment in this population is warranted given high level of distress at presentation to care. TRIAL REGISTRATION: ClinicalTrials.Gov NCT01934075.