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Moderate DepressionAFFIRM-SANCT01977326

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

A study testing basic counselling by lay-health workers in people with Moderate Depression and Clinical Depression, run by University of Cape Town at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
basic counselling by lay-health workers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,205 participants
Where
2 sitesSouth Africa
Study dates
Oct 2013to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • Michael Mapongwana Clinic

    Cape Town, Western Cape, 7000

  • Site B Clinic

    Cape Town, Western Cape

Other trials in South Africa

About this study

Official title: The Effectiveness and Cost-effectiveness of a 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)

Read the 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.
Being tested
basic counselling by lay-health workers, Enhanced usual care
Keywords
task sharing, task shifting, prenatal depression, counselling, lay health workers
Medical subject headings
Depressive Disorder, Major, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • basic counselling by lay-health workersBehavioural

    Also called task sharing intervention for maternal depression

    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)

Study groups in NCT01977326
Study groupRoleWhat they receive
counseling interventionExperimentalEach woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers
Receives: Behavioral: basic counselling by lay-health workers
Enhanced usual careActive comparatorusual antenatal care with additional 3 - 4 monthly phone calls.
Receives: Other: Enhanced usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton depression rating Scale (HAM-D)

    Measured: baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally

Secondary outcomes (7)

  1. 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

    Measured: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up

  2. 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.

    Measured: baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up

  3. Multidimensional Scale of Perceived Social Support (MSPSS)

    Measured: 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

    Measured: 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

    Measured: 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

    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

    Measured: baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up

  7. Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation

    Measured: follow-up 3 months postnatal follow-up 12 months postnatal follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
4,205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01977326
Sponsor's protocol ID
5U19MH095699-02
Other IDs
1U19MH095699
Acronym
AFFIRM-SA
Status last verified
Oct 2016
First submitted
24 Oct 2013
Last updated
28 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32241330

  • 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.

    PubMed 31733813

  • 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.

    PubMed 28666425

  • 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.

    PubMed 25567235

  • 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.

    PubMed 25416557

Questions about this trial

What is this clinical trial studying?

A study testing basic counselling by lay-health workers in people with Moderate Depression and Clinical Depression, run by University of Cape Town at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton depression rating Scale (HAM-D) (time frame: baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01977326, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.

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