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

Postpartum Depression Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977326
• Other study ID #: 5U19MH095699-02
• Secondary ID: 1U19MH095699
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: October 27, 2016
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4205
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Depression
• Depression
• Depression, Postpartum
• Depressive Disorder
• Moderate Depression
• Postpartum Depression

Intervention

Behavioral:
• basic counselling by lay-health workers
6 sessions of manual based counselling by trained lay health workers

Other:
• Enhanced usual care
3 monthly phone calls by trained lay health workers (without counselling)

Locations

Country	Name	City	State
South Africa	Michael Mapongwana Clinic	Cape Town	Western Cape
South Africa	Site B Clinic	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating Scale (HAM-D)		baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally	No
Secondary	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	baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up	No
Secondary	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.	baseline and change in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	baseline and changes in scores at 1 month before birth follow-up 3 months postnatal follow-up 12 months postnatal follow-up	No
Secondary	Obstetric and Infant outcome measures (head circumference, weight, height, feeding, diarrhoea, respiratory tract infections, immunisation		follow-up 3 months postnatal follow-up 12 months postnatal follow-up	No

External Links

•   website for overall project in which the AFFIRM-SA trial is located