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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01172106
Other study ID # 2006/HD11/4572U
Secondary ID
Status Recruiting
Phase N/A
First received July 28, 2010
Last updated July 28, 2010
Start date August 2008
Est. completion date October 2010

Study information

Verified date July 2010
Source Makerere University
Contact Janet Nakigudde
Phone +256-772-407-885
Email jnakigudde@hotmail.com
Is FDA regulated No
Health authority Uganda: Ministry of Health
Study type Interventional

Clinical Trial Summary

There is currently no clear involvement of families/caregivers in the care for postpartum mothers that develop postpartum psychosis. The lack of knowledge on causes of postpartum psychosis may influence the nature of perceived social support that mothers receive from caregivers. It is hoped that the provision of a culturally adapted version of family psychoeducation will bridge the knowledge gap and provide the much needed information. We therefore hypothesized that the involvement of a family member of a postpartum mother with a psychotic illness in a weekly session of family psychoeducation.


Description:

Postpartum psychosis causes distress to the mother, baby, spouse and other primary caregivers. This is especially true for Uganda where cultural beliefs for the causation of the illness place blame on supposedly the postpartum mother's promiscuity during pregnancy (COX, 1979). Cultural perceptions on the causes of postpartum psychosis may affect the nature of social support the mothers perceive from their families when they develop the illness. Other perceptions regarding postpartum psychosis in Uganda lay blame on supernatural causes like witchcraft.

Family psychoeducation which sets out to inform families of the nature of the illness is called for so as to demystify the illness.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 50 Years
Eligibility Inclusion Criteria:

- Postpartum mothers with a psychiatric illness in the current postpartum period.

- Must have been admitted to the mental health facility for the current episode.

Exclusion Criteria:

- Mothers residing out of a radius of 50 km away from the health facility.

- Mothers that do not have caregivers.

- Mothers who are not fluent in the language in which the study will be conducted.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Intervention

Behavioral:
drug compliance
Mothers and their caregivers will be encouraged to comply with the given medication
Encouragement of drug compliance
Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement
Family psychoeducation
The experimental group will receive family psychoeducation for 12 sessions

Locations

Country Name City State
Uganda Makerere University College of Health Sciences Kampala
Uganda Makerere University College of Health Sciences Kampala

Sponsors (2)

Lead Sponsor Collaborator
Makerere University Swedish International Development Cooperation Agency (SIDA)

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary perceived social support of mothers 12 weekly sessions of family psychoeducation for a period of 3 months will improve perceived social support of mothers in the intervention arm. 3 months No
Secondary Improvement of psychological distress of the caregivers 12 weekly sessions of family psychoeducation with caregivers for a period of 3 months will improve psychological distress in caregivers of mothers that will have received family psychoeducation 3 months No
See also
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Completed NCT02661789 - Neuropsychobiological Correlates of Sex-steroid Hormone Manipulation in Healthy Women: a Risk Model for Depression N/A
Recruiting NCT05314153 - Effects Zulresso on Postpartum Psychosis Early Phase 1