Clinical trial NCT01977326: Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Official title: The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Depression
Clinical Depression
Postpartum Depression
Keywords: task sharing
task shifting
prenatal depression
counselling
lay health workers
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-11-06
Enrollment: 4205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomised controlled trial (RCT) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa(i.e. provided by non-specialist health workers)

Detailed description: Specific Objectives:

1. To determine the effectiveness and cost-effectiveness of task sharing care to community health workers (CHWs), compared to enhanced usual care in South Africa, on both primary outcome measures (severity of prenatal maternal depression symptoms) and on a series of secondary outcome measures (functional status, health care utilization, social support and postnatal infant growth).
2. To examine factors influencing the implementation of the task sharing intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task sharing from the perspectives of both CHWs and patients.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Living in Khayelitsha
3. 18 years or older
4. Screen positive for depression with a cut off of 13 or more on the EPDS
5. Able to give informed consent

Exclusion Criteria:

* 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.
* Women who do not speak isiXhosa as a first language

Primary outcomes:
measure: Hamilton depression rating Scale (HAM-D)
timeFrame: baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally
Secondary outcomes:
measure: Edinburgh Postnatal depression scale (EPDS)
timeFrame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
measure: Mini International Psychiatric Interview 2.0.0 (MINI) Major depression
timeFrame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
measure: WHO Disability Assessment Schedule (WHO-DAS) 12 item version 2.0
timeFrame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
measure: Health services utilisation questionnaire
timeFrame: baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
measure: Cape Town Functional Assessment Instrument for Maternal Depression
timeFrame: baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
measure: Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation
timeFrame: follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Michael Mapongwana Clinic
state: Western Cape
city: Cape Town
country: South Africa
facility: Site B Clinic
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Crick Lund, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mailman School of Public Health, Columbia University
name: Ezra Susser, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Ababa University
name: Atalay Alem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cleary S, Orangi S, Garman E, Tabani H, Schneider M, Lund C. Economic burden of maternal depression among women with a low income in Cape Town, South Africa. BJPsych Open. 2020 Apr 3;6(3):e36. doi: 10.1192/bjo.2020.15.
citation: Lund C, Schneider M, Garman EC, Davies T, Munodawafa M, Honikman S, Bhana A, Bass J, Bolton P, Dewey M, Joska J, Kagee A, Myer L, Petersen I, Prince M, Stein DJ, Tabana H, Thornicroft G, Tomlinson M, Hanlon C, Alem A, Susser E. Task-sharing of psychological treatment for antenatal depression in Khayelitsha, South Africa: Effects on antenatal and postnatal outcomes in an individual randomised controlled trial. Behav Res Ther. 2020 Jul;130:103466. doi: 10.1016/j.brat.2019.103466. Epub 2019 Oct 31.
citation: Munodawafa M, Lund C, Schneider M. A process evaluation exploring the lay counsellor experience of delivering a task shared psycho-social intervention for perinatal depression in Khayelitsha, South Africa. BMC Psychiatry. 2017 Jul 1;17(1):236. doi: 10.1186/s12888-017-1397-9.
citation: Schneider M, Baron E, Davies T, Bass J, Lund C. Making assessment locally relevant: measuring functioning for maternal depression in Khayelitsha, Cape Town. Soc Psychiatry Psychiatr Epidemiol. 2015 May;50(5):797-806. doi: 10.1007/s00127-014-1003-0. Epub 2015 Jan 8.
citation: Lund C, Schneider M, Davies T, Nyatsanza M, Honikman S, Bhana A, Bass J, Bolton P, Dewey M, Joska J, Kagee A, Myer L, Petersen I, Prince M, Stein DJ, Thornicroft G, Tomlinson M, Alem A, Susser E. Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa: study protocol for a randomized controlled trial. Trials. 2014 Nov 21;15:457. doi: 10.1186/1745-6215-15-457.