- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172106
Impact of Family Psychoeducation on Psychosis
The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kampala, Uganda, 7072
- Recruiting
- Makerere University College of Health Sciences
-
Contact:
- Janet Nakigudde
- Phone Number: +256-772-407-885
- Email: jnakigudde@hotmail.com
-
Contact:
- Eija Airaksinen
- Phone Number: +468737840
- Email: eija.airaksinen@ki.se
-
Principal Investigator:
- Janet Nakigudde
-
Kampala, Uganda, P.O.Box 7072
- Recruiting
- Makerere University College of Health Sciences
-
Contact:
- Janet Nakigudde
- Phone Number: +256-772-407-885
- Email: jnakigudde@hotmail.com
-
Principal Investigator:
- Janet Nakigudde
-
Contact:
- Eija Airksinen
- Phone Number: +46-87373857
- Email: eija.airaksinen@ki.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Encouragement on drug compliance
The intervention for the placebo comparator will be encouragement on drug compliance
|
Mothers and their caregivers will be encouraged to comply with the given medication
Other Names:
Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement
Other Names:
|
|
Experimental: Family psychoeducation
The experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement
|
The experimental group will receive family psychoeducation for 12 sessions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perceived social support of mothers
Time Frame: 3 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of psychological distress of the caregivers
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eija Airaksinen, Karolinska Institutet
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/HD11/4572U
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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