Inge Petersen1, Lara Fairall2, Babalwa Zani3, Arvin Bhana4, Carl Lombard5, Naomi Folb6, One Selohilwe7, Daniella Georgeu-Pepper8, Ruwayda Petrus9, Ntokozo Mntambo10, Tasneem Kathree11, Max Bachmann12, Naomi Levitt13, Graham Thornicroft14, Crick Lund15. 1. Centre for Rural Health and School of Applied Human Sciences, University of KwaZulu- Natal, South Africa. Howard College, Mazisi Kunene Avenue, Durban, 4001, South Africa. Electronic address: peterseni@ukzn.ac.za. 2. Global King's Health Institute, Kings College London, United Kingdom; Knowledge Translation Unit, University of Cape Town, South Africa. Electronic address: lara.fairall@uct.ac.za. 3. Knowledge Translation Unit, University of Cape Town, South Africa. Electronic address: babalwa.zani@uct.ac.za. 4. Centre for Rural Health and School of Applied Human Sciences, University of KwaZulu- Natal, South Africa. Howard College, Mazisi Kunene Avenue, Durban, 4001, South Africa; Health Systems Research Unit, South African Medical Research Council, South Africa. Electronic address: Arvin.Bhana@gmail.com. 5. Biostatistics Unit, South African Medical Research Council, South Africa. Carl Lombard; Division of Epidemiology and Biostatistics, Department of Global Health, University of Stellenbosch, South Africa. Electronic address: Carl.Lombard@mrc.ac.za. 6. Knowledge Translation Unit, University of Cape Town, South Africa. Electronic address: naomifolb@gmail.com. 7. Centre for Rural Health and School of Applied Human Sciences, University of KwaZulu- Natal, South Africa. Howard College, Mazisi Kunene Avenue, Durban, 4001, South Africa. Electronic address: selohilweone@gmail.com. 8. Knowledge Translation Unit, University of Cape Town, South Africa. Electronic address: daniella.georgeu-pepper@uct.ac.za. 9. School of Applied Human Sciences, University of KwaZulu-Natal, South Africa. Electronic address: petrus@ukzn.ac.za. 10. School of Applied Human Sciences, University of KwaZulu-Natal, South Africa. Electronic address: Mntambo@ukzn.ac.za. 11. Centre for Rural Health and School of Applied Human Sciences, University of KwaZulu- Natal, South Africa. Howard College, Mazisi Kunene Avenue, Durban, 4001, South Africa. Electronic address: kathree@ukzn.ac.za. 12. Norwich Medical School, University of East Anglia, United Kingdom. Electronic address: M.Bachmann@uea.ac.uk. 13. Division of Endocrinology, University of Cape Town, South Africa. Electronic address: naomi.levitt@uct.ac.za. 14. Centre for Global Mental Health and Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom. Electronic address: graham.thornicroft@kcl.ac.uk. 15. Centre for Global Mental Health and Centre for Implementation Science, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: crick.lund@uct.ac.za.
Abstract
BACKGROUND: We tested the real-world effectiveness of a collaborative task-sharing model on depressive symptom reduction in hypertensive Primary Health Care (PHC) patients in South Africa. METHOD: A pragmatic parallel cluster randomised trial in 20 clinics in the Dr Kenneth Kaunda district, North West province. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Control clinics received care as usual (CAU), involving referral to PHC doctors and/or mental health specialists. Intervention clinics received CAU plus enhanced mental health training and a lay counselling referral service. Participant inclusion criteria were ≥ 18 years old, Patient Health Questionnaire-9 (PHQ-9) score ≥ 9 and receiving hypertension medication. Primary superiority outcome was ≥ 50% reduction in PHQ-9 score at 6 months. Statistical analyses comprised mixed effects regression models and a non-inferiority analysis. TRIAL REGISTRATION NUMBER: NCT02425124. RESULTS:Between April 2015 and October 2015, 1043 participants were enrolled (504 intervention and 539 control); 82% were women; half were ≥ 55 years. At 6 and 12 months follow-up, 91% and 89% of participants were interviewed respectively. One control group participant committed suicide. There was no significant difference in the primary outcome between intervention (N=256/456) and control (N=232/492) groups (55.9% versus 50.9%; adjusted risk difference = -0.04 ([95% CI = -0.19; 0.11], p = 0.6). The difference in PHQ-9 scores was within the defined equivalence limits at 6 and 12 months for the non-inferiority analysis. LIMITATIONS: The trial was limited by low exposure to depression treatment by trial participants and by observed co-intervention in control clinics CONCLUSIONS: Incorporating lay counselling services within collaborative care models does not produce superior nor inferior outcomes to models with specialist only counselling services. FUNDING: This work was supported by the UK Department for International Development [201446] as well as the National Institute of Mental Health, United States of America, grant number 1R01MH100470-01. Graham Thornicroft is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King's College London and King's College Hospital NHS Foundation Trust.
RCT Entities:
BACKGROUND: We tested the real-world effectiveness of a collaborative task-sharing model on depressive symptom reduction in hypertensive Primary Health Care (PHC) patients in South Africa. METHOD: A pragmatic parallel cluster randomised trial in 20 clinics in the Dr Kenneth Kaunda district, North West province. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Control clinics received care as usual (CAU), involving referral to PHC doctors and/or mental health specialists. Intervention clinics received CAU plus enhanced mental health training and a lay counselling referral service. Participant inclusion criteria were ≥ 18 years old, Patient Health Questionnaire-9 (PHQ-9) score ≥ 9 and receiving hypertension medication. Primary superiority outcome was ≥ 50% reduction in PHQ-9 score at 6 months. Statistical analyses comprised mixed effects regression models and a non-inferiority analysis. TRIAL REGISTRATION NUMBER: NCT02425124. RESULTS: Between April 2015 and October 2015, 1043 participants were enrolled (504 intervention and 539 control); 82% were women; half were ≥ 55 years. At 6 and 12 months follow-up, 91% and 89% of participants were interviewed respectively. One control group participant committed suicide. There was no significant difference in the primary outcome between intervention (N=256/456) and control (N=232/492) groups (55.9% versus 50.9%; adjusted risk difference = -0.04 ([95% CI = -0.19; 0.11], p = 0.6). The difference in PHQ-9 scores was within the defined equivalence limits at 6 and 12 months for the non-inferiority analysis. LIMITATIONS: The trial was limited by low exposure to depression treatment by trial participants and by observed co-intervention in control clinics CONCLUSIONS: Incorporating lay counselling services within collaborative care models does not produce superior nor inferior outcomes to models with specialist only counselling services. FUNDING: This work was supported by the UK Department for International Development [201446] as well as the National Institute of Mental Health, United States of America, grant number 1R01MH100470-01. Graham Thornicroft is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King's College London and King's College Hospital NHS Foundation Trust.
Authors: Christopher G Kemp; Ntokozo Mntambo; Bryan J Weiner; Merridy Grant; Deepa Rao; Arvin Bhana; Sithabisile Gugulethu Gigaba; Zamasomi Prudence Busisiwe Luvuno; Jane M Simoni; James P Hughes; Inge Petersen Journal: SSM Ment Health Date: 2021-07-22