EXPanding care fOr periNATal women with dEpression (EXPONATE)
Not Applicable
Completed
- Conditions
- DepressionMental and Behavioural DisordersDepressive episode, unspecified
- Registration Number
- ISRCTN60041127
- Lead Sponsor
- niversity of Ibadan (Nigeria)
- Brief Summary
1. 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26122982 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30767826
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 686
Inclusion Criteria
1. Women aged between the age of 16 and 45 years
2. Gestational age of between 16 and 26 weeks
3. Score 12 or more on the Edinburgh Postnatal Depression Scale
4. Confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of major depression using the short form of the Composite International Diagnostic Interview (CIDI)
5. Provide informed consent
Exclusion Criteria
1. Immediate need for medical attention
2. Actively suicidal
3. Presence of bipolar or psychotic disorder
4. Unlikely to be in the neighbourhood in the following 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Baseline assessments will be conducted within 72 hours of patients consenting to enter the trial.<br><br> Recovery from depression at 6 months after childbirth (i.e. no longer meets the criteria for DSM-IV major depression)<br>
- Secondary Outcome Measures
Name Time Method <br> Baseline assessments will be conducted within 72 hours of patients consenting to enter the trial.<br><br> 1. Score on EPDS at 3, 9 and 12 months<br> 2. Disability, measured with the WHO Disability Assessment Schedule, at 3, 9 and 12 months<br> 3. Service utilization, measured with Client Service Receipt Inventory<br> 4. Postnatal version, at 3, 9 and 12 months<br> 5. Infant outcome at 12 months measured with the Bayley Scale<br>