Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania
Condition: Other Obstetric Trauma OS
MeSH terms: Fistula
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a mental health intervention for obstetric
      fistula patients in Tanzania improves 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).
    

Detailed description: 
      Obstetric fistula is a hole between the bladder or rectum 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. Multiple studies
      have documented the social and psychological impact of obstetric fistula, which includes
      social isolation, stigma, depression, and mental health dysfunction. The surgical repair
      setting can be a window of opportunity to address the accumulated mental health distress of
      living with a fistula. 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). The proposed
      research directly responds to the needs specified by NIH because it expands the "evidence
      base for improving social outcomes" of women with obstetric fistula and develops a
      "sustainable intervention" that complements existing local care (PA-11-143). At the
      completion of this study, it is our expectation that we will have a structured intervention
      curriculum and supportive preliminary data to inform an R01 application to conduct a
      multi-site evaluation of the intervention, which, if effective, can be disseminated to
      fistula repair clinics internationally.
    

Intervention name(s): Mental health treatment
Intervention type(s): Behavioral
Intervention description(s): 6 sessions of individual mental health counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstetric fistula; Mental health; Tanzania