AFFIRM-SA trial
- Conditions
- Pregnancy and Childbirthperinatal depression
- Registration Number
- PACTR201403000676264
- Lead Sponsor
- Alan J Flisher Centre for Public Mental Health, Psychiatry and Mental Health, University of Cape Town
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 420
¿Women attending antenatal clinics at the Michael Mapongwana Community Health Centre in Khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation
¿Living in Khayelitsha
¿18 years or older
¿Screen positive for depression with a cut off of 13 or more on the EPDS
¿Able to give informed consent
¿Require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis.
¿Individuals assessed as being suicidal and requiring immediate referral to a mental health specialist (as indicated by a score of 17 or higher on the Suicide module of the Mini International Neuropsychiatric Interview 6.0.0 (MINI).
¿Women who do not speak isiXhosa as a first language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method scores on Hamilton depression rating scale
- Secondary Outcome Measures
Name Time Method Edinburgh Postnatal depression scale (EPDS);Mini International Psychiatric Interview 2.0.0 (MINI) Major depression ;Mini International Psychiatric Interview 2.0.0 (MINI) Suicidality;Multidimensional Scale of Perceived Social Support (MSPSS);WHO-DAS 2.0 12 item version;Health services utilisation questionnaire;Cape Town Functional Assessment Instrument for Maternal Depression;Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation