Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01934075
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2013-08-29
Brief Title:
Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21HD073681 | NIH | None | httpsreporternihgovquickSearchR21HD073681 |