Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa

Not Applicable

Completed

• Conditions: Moderate Depression; Postpartum Depression; Clinical Depression
• Interventions: Behavioral: basic counselling by lay-health workers; Other: Enhanced usual care

• Registration Number: NCT01977326
• Lead Sponsor: University of Cape Town

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
counseling intervention	basic counselling by lay-health workers	Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers
Enhanced usual care	Enhanced usual care	usual antenatal care with additional 3 - 4 monthly phone calls.

Primary Outcome Measures

Name	Time	Method
Hamilton depression rating Scale (HAM-D)	baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally

Secondary Outcome Measures

Name	Time	Method
Mini International Psychiatric Interview 2.0.0 (MINI) Major depression	baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up	Major Depression and Suicidality modules are used. A score of 17 or higher on the suicidality module indicates need for referral for additional treatment. These women remain in the trial.
Edinburgh Postnatal depression scale (EPDS)	baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up	Screening tool to identify depressive symptoms; score of 13 or higher indicates a positive screen for depressive symptoms and woman is recruited into the study
Multidimensional Scale of Perceived Social Support (MSPSS)	baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
WHO Disability Assessment Schedule (WHO-DAS) 12 item version 2.0	baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Health services utilisation questionnaire	baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Cape Town Functional Assessment Instrument for Maternal Depression	baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up	locally relevant functional assessment instrument developed for use with the specific target population of the trial - pregnant women and mothers of young babies living in Khayelitsha, Cape Town - the study site. This outcome measure complements the WHO-DAS 2.0
Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation	follow-up 3 months postnatal follow-up 12 months postnatal follow-up

Trial Locations

Locations (2)

Michael Mapongwana Clinic; 🇿🇦 Cape Town, Western Cape, South Africa

Site B Clinic; 🇿🇦 Cape Town, Western Cape, South Africa