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

NCT ID: NCT01977326

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Moderate Depression Clinical Depression Postpartum Depression

Keywords

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task sharing task shifting prenatal depression counselling lay health workers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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counseling intervention

Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers

Group Type EXPERIMENTAL

basic counselling by lay-health workers

Intervention Type BEHAVIORAL

6 sessions of manual based counselling by trained lay health workers

Enhanced usual care

usual antenatal care with additional 3 - 4 monthly phone calls.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type OTHER

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

Interventions

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basic counselling by lay-health workers

6 sessions of manual based counselling by trained lay health workers

Intervention Type BEHAVIORAL

Enhanced usual care

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

Intervention Type OTHER

Other Intervention Names

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task sharing intervention for maternal depression

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Cape Town

OTHER

Sponsor Role lead

Responsible Party

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A/Prof Crick Lund

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Crick Lund, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Ezra Susser, PhD

Role: PRINCIPAL_INVESTIGATOR

Mailman School of Public Health, Columbia University

Atalay Alem, PhD

Role: PRINCIPAL_INVESTIGATOR

Addis Ababa University

Locations

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Michael Mapongwana Clinic

Cape Town, Western Cape, South Africa

Site Status

Site B Clinic

Cape Town, Western Cape, South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type DERIVED
PMID: 32241330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31733813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28666425 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25567235 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25416557 (View on PubMed)

Other Identifiers

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1U19MH095699

Identifier Type: NIH

Identifier Source: secondary_id

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5U19MH095699-02

Identifier Type: NIH

Identifier Source: org_study_id

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