Impact of Family Psychoeducation on Psychosis
Primary Purpose
Postpartum Psychosis
Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
drug compliance
Encouragement of drug compliance
Family psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Postpartum Psychosis focused on measuring Postpartum psychosis, Perceived social support, Family psychoeducation
Eligibility Criteria
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.
Sites / Locations
- Makerere University College of Health SciencesRecruiting
- Makerere University College of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Encouragement on drug compliance
Family psychoeducation
Arm Description
The intervention for the placebo comparator will be encouragement on drug compliance
The experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01172106
First Posted
July 28, 2010
Last Updated
July 28, 2010
Sponsor
Makerere University
Collaborators
Swedish International Development Cooperation Agency (SIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01172106
Brief Title
Impact of Family Psychoeducation on Psychosis
Official Title
The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Makerere University
Collaborators
Swedish International Development Cooperation Agency (SIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Psychosis
Keywords
Postpartum psychosis, Perceived social support, Family psychoeducation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Encouragement on drug compliance
Arm Type
Placebo Comparator
Arm Description
The intervention for the placebo comparator will be encouragement on drug compliance
Arm Title
Family psychoeducation
Arm Type
Experimental
Arm Description
The experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement
Intervention Type
Behavioral
Intervention Name(s)
drug compliance
Other Intervention Name(s)
Psychosocial intervention
Intervention Description
Mothers and their caregivers will be encouraged to comply with the given medication
Intervention Type
Behavioral
Intervention Name(s)
Encouragement of drug compliance
Other Intervention Name(s)
Psychosocial intervention
Intervention Description
Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement
Intervention Type
Behavioral
Intervention Name(s)
Family psychoeducation
Other Intervention Name(s)
Psychosocial intervention
Intervention Description
The experimental group will receive family psychoeducation for 12 sessions
Primary Outcome Measure Information:
Title
perceived social support of mothers
Description
12 weekly sessions of family psychoeducation for a period of 3 months will improve perceived social support of mothers in the intervention arm.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement of psychological distress of the caregivers
Description
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
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Nakigudde
Phone
+256-772-407-885
Email
jnakigudde@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Nakigudde
Phone
+256-772-407-885
Email
jnakigudde@chs.mak.ac.ug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eija Airaksinen
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Makerere University College of Health Sciences
City
Kampala
ZIP/Postal Code
7072
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Nakigudde
Phone
+256-772-407-885
Email
jnakigudde@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eija Airaksinen
Phone
+468737840
Email
eija.airaksinen@ki.se
First Name & Middle Initial & Last Name & Degree
Janet Nakigudde
Facility Name
Makerere University College of Health Sciences
City
Kampala
ZIP/Postal Code
P.O.Box 7072
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Nakigudde
Phone
+256-772-407-885
Email
jnakigudde@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eija Airksinen
Phone
+46-87373857
Email
eija.airaksinen@ki.se
First Name & Middle Initial & Last Name & Degree
Janet Nakigudde
12. IPD Sharing Statement
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Impact of Family Psychoeducation on Psychosis
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