Overview

This trial has been completed.

Conditions moderate depression, clinical depression, postpartum depression
Treatments basic counselling by lay-health workers, enhanced usual care
Sponsor University of Cape Town
Collaborator National Institute of Mental Health (NIMH)
Start date October 2013
End date June 2016
Trial size 4205 participants
Trial identifier NCT01977326, 1U19MH095699, 5U19MH095699-02

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers
basic counselling by lay-health workers task sharing intervention for maternal depression
6 sessions of manual based counselling by trained lay health workers
(Active Comparator)
usual antenatal care with additional 3 - 4 monthly phone calls.
enhanced usual care
3 monthly phone calls by trained lay health workers (without counselling)

Primary Outcomes

Measure
Hamilton depression rating Scale (HAM-D)
time frame: baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally

Secondary Outcomes

Measure
Edinburgh Postnatal depression scale (EPDS)
time frame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Mini International Psychiatric Interview 2.0.0 (MINI) Major depression
time frame: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)
time frame: 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
time frame: 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
time frame: 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
time frame: baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation
time frame: follow-up 3 months postnatal follow-up 12 months postnatal follow-up

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Principal investigator Crick Lund, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Cape Town.