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Impact of Family Psychoeducation on Psychosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Makerere University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Swedish International Development Cooperation Agency (SIDA)
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT01172106
First received: July 28, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Postpartum Psychosis
Behavioral: drug compliance
Behavioral: Encouragement of drug compliance
Behavioral: Family psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • perceived social support of mothers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Encouragement on drug compliance
The intervention for the placebo comparator will be encouragement on drug compliance
Behavioral: drug compliance
Mothers and their caregivers will be encouraged to comply with the given medication
Other Name: Psychosocial intervention
Behavioral: Encouragement of drug compliance
Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement
Other Name: Psychosocial intervention
Experimental: Family psychoeducation
The experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement
Behavioral: Family psychoeducation
The experimental group will receive family psychoeducation for 12 sessions
Other Name: Psychosocial intervention

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.

  Eligibility

Ages Eligible for Study:   13 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172106

Contacts
Contact: Janet Nakigudde +256-772-407-885 jnakigudde@hotmail.com
Contact: Janet Nakigudde +256-772-407-885 jnakigudde@chs.mak.ac.ug

Locations
Uganda
Makerere University College of Health Sciences Recruiting
Kampala, Uganda, P.O.Box 7072
Contact: Janet Nakigudde    +256-772-407-885    jnakigudde@hotmail.com   
Contact: Eija Airksinen    +46-87373857    eija.airaksinen@ki.se   
Principal Investigator: Janet Nakigudde         
Makerere University College of Health Sciences Recruiting
Kampala, Uganda, 7072
Contact: Janet Nakigudde    +256-772-407-885    jnakigudde@hotmail.com   
Contact: Eija Airaksinen    +468737840    eija.airaksinen@ki.se   
Principal Investigator: Janet Nakigudde         
Sponsors and Collaborators
Makerere University
Swedish International Development Cooperation Agency (SIDA)
Investigators
Study Director: Eija Airaksinen Karolinska Institutet
  More Information

No publications provided

Responsible Party: Janet Nakigudde, Department of Psychiatry, College of Health Sciences, Makerere University
ClinicalTrials.gov Identifier: NCT01172106     History of Changes
Other Study ID Numbers: 2006/HD11/4572U
Study First Received: July 28, 2010
Last Updated: July 28, 2010
Health Authority: Uganda: Ministry of Health

Keywords provided by Makerere University:
Postpartum psychosis
Perceived social support
Family psychoeducation

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014