Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania
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|ClinicalTrials.gov Identifier: NCT01934075|
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Other Obstetric Trauma OS||Behavioral: Mental health treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of Mental Health Treatment for Obstetric Fistula Patients in Tanzania|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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.
- Depression symptoms [ Time Frame: 90 days ]Self-report, measured by Center for Epidemiological Studies Depression Scale (CES-D)
- PTSD symptoms [ Time Frame: 90 days ]Self-report, measured by the PTSD Checklist, civilian version
- Anxiety symptoms [ Time Frame: 90 days ]Self-report, measured by the Beck Anxiety Inventory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934075
|Kilimanjaro Christian Medical Center|
|Principal Investigator:||Melissa Watt, PhD||Duke University|