NCT01172106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 29, 2010

Status Verified

July 1, 2010

Enrollment Period

2.1 years

First QC Date

July 28, 2010

Last Update Submit

July 28, 2010

Conditions

Keywords

Postpartum psychosisPerceived social supportFamily psychoeducation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Improvement of psychological distress of the caregivers

    3 months

Study Arms (2)

Encouragement on drug compliance

PLACEBO COMPARATOR

The intervention for the placebo comparator will be encouragement on drug compliance

Behavioral: drug complianceBehavioral: 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

Behavioral: Family psychoeducation

Interventions

drug complianceBEHAVIORAL

Mothers and their caregivers will be encouraged to comply with the given medication

Also known as: Psychosocial intervention
Encouragement on drug compliance

Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement

Also known as: Psychosocial intervention
Encouragement on drug compliance

The experimental group will receive family psychoeducation for 12 sessions

Also known as: Psychosocial intervention
Family psychoeducation

Eligibility Criteria

Age13 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Postpartum mothers with a psychiatric illness in the current postpartum period.
  • Must have been admitted to the mental health facility for the current episode.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Makerere University College of Health Sciences

Kampala, 7072, Uganda

RECRUITING

Makerere University College of Health Sciences

Kampala, P.O.Box 7072, Uganda

RECRUITING

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eija Airaksinen

    Karolinska Institutet

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 29, 2010

Study Start

August 1, 2008

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

July 29, 2010

Record last verified: 2010-07

Locations