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

NCT01977326 | Completed DMC

• 2 other identifiers: 5U19MH095699-021U19MH095699
• Study Type: interventional
• Target: 4,205
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Moderate Depression; Clinical Depression; Postpartum Depression

Keywords

task sharing; task shifting; prenatal depression; counselling; lay health workers

Outcome Measures

Primary Outcomes (1)

• Hamilton depression rating Scale (HAM-D)

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

Secondary Outcomes (7)

• Edinburgh Postnatal depression scale (EPDS)

  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

  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)

  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

  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

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

Study Arms (2)

counseling intervention

EXPERIMENTAL

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

Behavioral: basic counselling by lay-health workers

Enhanced usual care

ACTIVE COMPARATOR

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

Other: Enhanced usual care

Interventions

basic counselling by lay-health workers BEHAVIORAL

6 sessions of manual based counselling by trained lay health workers

Also known as: task sharing intervention for maternal depression

counseling intervention

Enhanced usual care OTHER

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

Enhanced usual care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years or older
• Screen positive for depression with a cut off of 13 or more on the EPDS
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Michael Mapongwana Clinic

Cape Town, Western Cape, 7000, South Africa

Location

Site B Clinic

Cape Town, Western Cape, South Africa

Location

Related Publications (5)

• 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.

  PMID: 32241330 DERIVED

• 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.

  PMID: 31733813 DERIVED

• 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.

  PMID: 28666425 DERIVED

• 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.

  PMID: 25567235 DERIVED

• 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.

  PMID: 25416557 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression, Postpartum

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Crick Lund, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Ezra Susser, PhD

  Mailman School of Public Health, Columbia University

  PRINCIPAL INVESTIGATOR

• Atalay Alem, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

ZA (2)