Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania
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).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania|
- Depression symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]Self-report, measured by Center for Epidemiological Studies Depression Scale (CES-D)
- PTSD symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]Self-report, measured by the PTSD Checklist, civilian version
- Somatic symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]Self report, measured by the Bradford Somatic Inventory
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Mental health treatment
Participants will receive twice-weekly exposure to 6 sessions of individual mental health treatment in a private room. Sessions will follow the intervention manual and be delivered by a full-time nurse facilitator who has a counseling background and receives supervision by a trained therapist.
Behavioral: Mental health treatment
6 sessions of individual mental health counseling.
No Intervention: Standard of Care
Participants in the control condition will receive counseling that is the current standard of care for fistula patients at KCMC.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934075
|Kilimanjaro Christian Medical Center||Recruiting|
|Contact: Gileard Masenga, MD +255754465424 firstname.lastname@example.org|
|Principal Investigator: Gileard Masenga, MD|
|Principal Investigator:||Melissa Watt, PhD||Duke University|