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Completed

NCT Number: NCT01977326

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

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)

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Key information

Conditions

Moderate Depression Clinical Depression Depression, Postpartum Depressive Disorder Depressive Disorder, Major Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Michael Mapongwana Clinic, Cape Town, Western Cape, South Africa

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About this study

Specific Objectives:

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Living in Khayelitsha
  • 18 years or older
  • Screen positive for depression with a cut off of 13 or more on the EPDS
  • 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

Treatment and study plan

basic counselling by lay-health workers

Behavioral

6 sessions of manual based counselling by trained lay health workers

Other names: task sharing intervention for maternal depression

Enhanced usual care

Other

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

Primary outcomes

  1. 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

  1. 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

    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

  2. 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

    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.

  3. 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

  4. 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

  5. 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

  6. 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

    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

  7. 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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa

Acronym: AFFIRM-SA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2013
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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