PI: Melissa Watt Co-investigator: Kathleen J. Sikkema Funder: NICHD, R21, 2013-2015 (Supplementary funding by the Fistula Foundation) Partner: KCMC in Moshi, Tanzania

Obstetric fistula is a hole between the bladder and the vagina, which develops when obstructed labor is not relieved by cesarean section and results in uncontrollable leaking of urine and/or feces. The only cure for obstetric fistula is surgical repair, but many women suffer for years without treatment. Multiple studies have documented the social and psychological impact of obstetric fistula, which includes social isolation, stigma, depression, and mental health dysfunction. However, to date no intervention studies have evaluated empirically-supported therapies to assist in psychological healing among fistula patients. The proposed study aims to fill this gap by developing and pilot-testing a theoretically informed mental health intervention for women receiving surgical repair for obstetric fistula at KCMC Hospital in Moshi, Tanzania.

The study has three specific aims: 1) To develop the nurse-delivered mental health intervention, built on theories of coping and cognitive behavioral therapy, 2) To assess feasibility and acceptability of implementing the intervention in the KCMC fistula ward, considering: intervention fidelity, patient satisfaction, provider feedback and cost of delivery, 3) To assess effectiveness of the intervention by comparing immediate and short term outcomes in 30 women who receive the experimental intervention with 30 women receiving the standard of care counseling, examining differences in primary outcomes (depression, PTSD and somatic symptoms) and secondary outcomes (coping, perceived stigma, social support, social participation, efficacy to engage with providers, adherence to clinical recommendations and social reintegration).

This study is complete. The intervention development process was published in a paper in the journal Evaluation and Program Planning. There, we describe the 6-session individual-level intervention, based on principles of cognitive behavioral therapy and coping theory, that was developed for delivery by a community-health nurse. Intervention outcomes are reported in Pilot and Feasibility Studies. A nurse-delivered mental health intervention was feasible to implement as part of in-patient clinical care and regarded positively. There were sharp and meaningful improvements in mental health outcomes among participants over time, with no evidence of differences by condition.