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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19MH095699 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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)
Specific Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| counseling intervention | Experimental | Each woman recruited into the intervention arm will undergo 6 sessions of basic counselling by lay-health workers |
|
| Enhanced usual care | Active Comparator | usual antenatal care with additional 3 - 4 monthly phone calls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| basic counselling by lay-health workers | Behavioral | 6 sessions of manual based counselling by trained lay health workers |
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton depression rating Scale (HAM-D) | baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Mapongwana Clinic | Cape Town | Western Cape | 7000 | South Africa | ||
| Site B Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32241330 | Derived | 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. | |
| 31733813 | 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. |
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| Enhanced usual care | Other | 3 monthly phone calls by trained lay health workers (without counselling) |
|
| 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 |
| 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 |
| 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 |
| 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 |
| Cape Town |
| Western Cape |
| South Africa |
| 28666425 | 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. |
| 25567235 | 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. |
| 25416557 | 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. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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