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Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa (AFFIRM-SA)

Primary Purpose

Moderate Depression, Clinical Depression, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
basic counselling by lay-health workers
Enhanced usual care
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depression focused on measuring task sharing, task shifting, prenatal depression, counselling, lay health workers

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Michael Mapongwana Clinic
  • Site B Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

counseling intervention

Enhanced usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hamilton depression rating Scale (HAM-D)

Secondary Outcome Measures

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
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.
Multidimensional Scale of Perceived Social Support (MSPSS)
WHO Disability Assessment Schedule (WHO-DAS) 12 item version 2.0
Health services utilisation questionnaire
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
Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation

Full Information

First Posted
October 24, 2013
Last Updated
October 27, 2016
Sponsor
University of Cape Town
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01977326
Brief Title
Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Acronym
AFFIRM-SA
Official Title
The Effectiveness and Cost-effectiveness of a Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Depression, Clinical Depression, Postpartum Depression
Keywords
task sharing, task shifting, prenatal depression, counselling, lay health workers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
4205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
counseling intervention
Arm Type
Experimental
Arm Description
Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
usual antenatal care with additional 3 - 4 monthly phone calls.
Intervention Type
Behavioral
Intervention Name(s)
basic counselling by lay-health workers
Other Intervention Name(s)
task sharing intervention for maternal depression
Intervention Description
6 sessions of manual based counselling by trained lay health workers
Intervention Type
Other
Intervention Name(s)
Enhanced usual care
Intervention Description
3 monthly phone calls by trained lay health workers (without counselling)
Primary Outcome Measure Information:
Title
Hamilton depression rating Scale (HAM-D)
Time Frame
baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal depression scale (EPDS)
Description
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
Title
Mini International Psychiatric Interview 2.0.0 (MINI) Major depression
Description
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
Title
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
Title
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
Title
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
Title
Cape Town Functional Assessment Instrument for Maternal Depression
Description
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
Time Frame
baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crick Lund, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ezra Susser, PhD
Organizational Affiliation
Mailman School of Public Health, Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atalay Alem, PhD
Organizational Affiliation
Addis Ababa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael Mapongwana Clinic
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7000
Country
South Africa
Facility Name
Site B Clinic
City
Cape Town
State/Province
Western Cape
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
32241330
Citation
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.
Results Reference
derived
PubMed Identifier
31733813
Citation
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.
Results Reference
derived
PubMed Identifier
28666425
Citation
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.
Results Reference
derived
PubMed Identifier
25567235
Citation
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.
Results Reference
derived
PubMed Identifier
25416557
Citation
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.
Results Reference
derived

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

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