Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 9, 2016
August 1, 2016
2.9 years
August 29, 2013
August 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression symptoms
Self-report, measured by Center for Epidemiological Studies Depression Scale (CES-D)
90 days
Secondary Outcomes (2)
PTSD symptoms
90 days
Anxiety symptoms
90 days
Study Arms (2)
Mental health treatment
EXPERIMENTALParticipants 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.
Standard of Care
NO INTERVENTIONParticipants in the control condition will receive counseling that is the current standard of care for fistula patients at KCMC.
Interventions
6 sessions of individual mental health counseling.
Eligibility Criteria
You may qualify if:
- Patients at the Kilimanjaro Christian Medical Center Obstetrics-Gynecology Department, receiving surgical repair for a fistula resulting from childbirth
You may not qualify if:
- Impaired mental status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kilimanjaro Christian Medical Center
Moshi, Tanzania
Related Publications (1)
Watt MH, Mosha MV, Platt AC, Sikkema KJ, Wilson SM, Turner EL, Masenga GG. A nurse-delivered mental health intervention for obstetric fistula patients in Tanzania: results of a pilot randomized controlled trial. Pilot Feasibility Stud. 2017 Sep 12;3:35. doi: 10.1186/s40814-017-0178-z. eCollection 2017.
PMID: 28912958DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Watt, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2013
First Posted
September 4, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 9, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Data will be made available upon request.