Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania

Not Applicable

Completed

• Conditions: Other Obstetric Trauma OS
• Interventions: Behavioral: Mental health treatment

• Registration Number: NCT01934075
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study Start: 2013-09
• Study First Posted: 2013-09-04
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients at the Kilimanjaro Christian Medical Center Obstetrics-Gynecology Department, receiving surgical repair for a fistula resulting from childbirth

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Exclusion Criteria

• Impaired mental status

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mental health treatment	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.

Primary Outcome Measures

Name	Time	Method
Depression symptoms	90 days	Self-report, measured by Center for Epidemiological Studies Depression Scale (CES-D)

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms	90 days	Self-report, measured by the Beck Anxiety Inventory
PTSD symptoms	90 days	Self-report, measured by the PTSD Checklist, civilian version

Trial Locations

Locations (1)

Kilimanjaro Christian Medical Center; 🇹🇿 Moshi, Tanzania