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

N/ACompletedNCT01977326

University of Cape Town4,205 enrolled

Overview

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)

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

4,205

Conditions

Moderate Depression Clinical Depression Postpartum Depression

Interventions

basic counselling by lay-health workersBEHAVIORAL

6 sessions of manual based counselling by trained lay health workers

Enhanced usual careOTHER

3 monthly phone calls by trained lay health workers (without counselling)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

Michael Mapongwana Clinic

Cape Town, Western Cape, South Africa

Site B Clinic

Cape Town, Western Cape, South Africa

Outcomes

Primary Outcomes

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

Edinburgh Postnatal depression scale (EPDS)

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

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

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.

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

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

Data from ClinicalTrials.gov

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