Postpartum PsychosisNCT01172106
Impact of Family Psychoeducation on Psychosis
A study testing drug compliance, Encouragement of drug compliance and Family psychoeducation in people with Postpartum Psychosis, run by Makerere University at 2 sites in Uganda.
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. Read more about this study
- Who is it for?
- Ages 13 to 50 years, women only
- Conditions the study is for
- Postpartum Psychosis
- What is being tested?
- drug compliance, Encouragement of drug compliance and Family psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUganda
- Study dates
- Aug 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Postpartum mothers with a psychiatric illness in the current postpartum period.
- Must have been admitted to the mental health facility for the current episode.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites, 2 recruiting
- Recruiting
Makerere University College of Health Sciences
Kampala, 7072
Janet Nakigudde, +256-772-407-885, jnakigudde@hotmail.com
Eija Airaksinen, +468737840, eija.airaksinen@ki.se
- Recruiting
Makerere University College of Health Sciences
Kampala, P.O.Box 7072
Janet Nakigudde, +256-772-407-885, jnakigudde@hotmail.com
Eija Airksinen, +46-87373857, eija.airaksinen@ki.se
About this study
Official title: The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness
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.
Read the 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.
- Conditions
- Postpartum Psychosis
- Being tested
- drug compliance, Encouragement of drug compliance, Family psychoeducation
- Keywords
- Postpartum psychosis, Perceived social support, Family psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug complianceBehavioural
Also called Psychosocial intervention
Mothers and their caregivers will be encouraged to comply with the given medication
Encouragement of drug complianceBehavioural
Also called Psychosocial intervention
Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement
Family psychoeducationBehavioural
Also called Psychosocial intervention
The experimental group will receive family psychoeducation for 12 sessions
| Study group | Role | What they receive |
|---|---|---|
| Encouragement on drug compliance | Placebo comparator | The intervention for the placebo comparator will be encouragement on drug compliance Receives: Behavioral: drug compliance; Behavioral: Encouragement of drug compliance |
| Family psychoeducation | Experimental | The experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement Receives: Behavioral: Family psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionSep 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Investigators
- Eija Airaksinen, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172106
- Sponsor's protocol ID
- 2006/HD11/4572U
- Status last verified
- Jul 2010
- First submitted
- 28 Jul 2010
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness
- ClinicalTrials.gov ID
- NCT01172106
- Acronym / sponsor ID
- 2006/HD11/4572U
- Conditions
- Postpartum Psychosis
- Keywords
- Postpartum psychosis, Perceived social support, Family psychoeducation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Encouragement on drug compliance | Placebo comparator | Behavioral: drug compliance, Behavioral: Encouragement of drug complianceThe intervention for the placebo comparator will be encouragement on drug compliance |
| Family psychoeducation | Experimental | Behavioral: Family psychoeducationThe experimental group will receive weekly sessions of psychoeducation for 12 weeks in addition to receiving drug compliance encouragement |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Postpartum mothers with a psychiatric illness in the current postpartum period.
- Must have been admitted to the mental health facility for the current episode.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug complianceAlso: Psychosocial interventionMothers and their caregivers will be encouraged to comply with the given medication | Behavioural | Encouragement on drug compliance |
| Encouragement of drug complianceAlso: Psychosocial interventionMothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement | Behavioural | Encouragement on drug compliance |
| Family psychoeducationAlso: Psychosocial interventionThe experimental group will receive family psychoeducation for 12 sessions | Behavioural | Family psychoeducation |
Primary outcome
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.
1 secondary outcome
Improvement of psychological distress of the caregivers
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
Related trials for Postpartum Psychosis
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Enrolling by invitationObservational study
Psychiatry Research and Motherhood at 6 to 8 (PRAM-P@6to8)
Perinatal Psychiatry
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija Airaksinen study director
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug compliance, Encouragement of drug compliance and Family psychoeducation in people with Postpartum Psychosis, run by Makerere University at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janet Nakigudde (+256-772-407-885, jnakigudde@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perceived social support of mothers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2010.