Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01934075
First received: August 29, 2013
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention
Other Obstetric Trauma OS
Behavioral: Mental health treatment

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Depression symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Self-report, measured by Center for Epidemiological Studies Depression Scale (CES-D)


Secondary Outcome Measures:
  • PTSD symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Self-report, measured by the PTSD Checklist, civilian version

  • Anxiety symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Self-report, measured by the Beck Anxiety Inventory


Enrollment: 60
Study Start Date: September 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934075

Locations
Tanzania
Kilimanjaro Christian Medical Center
Moshi, Tanzania
Sponsors and Collaborators
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kilimanjaro Christian Medical Centre, Tanzania
Investigators
Principal Investigator: Melissa Watt, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01934075     History of Changes
Other Study ID Numbers: R21HD073681 
Study First Received: August 29, 2013
Last Updated: August 8, 2016
Health Authority: Tanzania: National Institute for Medical Research
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be made available upon request.

Keywords provided by Duke University:
Obstetric fistula
Mental health
Tanzania

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 29, 2016