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Completed

NCT Number: NCT01934075

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).

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kilimanjaro Christian Medical Center

Moshi, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Impaired mental status

Treatment and study plan

Mental Health Treatment

Behavioral

6 sessions of individual mental health counseling.

Primary outcomes

  1. Depression symptoms

    Time frame: 90 days

    Self-report, measured by Center for Epidemiological Studies Depression Scale (CES-D)

Secondary outcomes

  1. PTSD symptoms

    Time frame: 90 days

    Self-report, measured by the PTSD Checklist, civilian version

  2. Anxiety symptoms

    Time frame: 90 days

    Self-report, measured by the Beck Anxiety Inventory

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kilimanjaro Christian Medical Centre, Tanzania

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2013
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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