Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial

Background: In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CH...

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Main Authors: Myers-Franchi, Bronwyn, Lund, C., Lombard, C., Joska, J., Levitt, N., Butler, C., Cleary, S., Naledi, T., Milligan, P., Stein, D.J., Sorsdahl, K.
Format: Journal Article
Language:English
Published: BMC 2018
Subjects:
Online Access:http://hdl.handle.net/20.500.11937/85712
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author Myers-Franchi, Bronwyn
Lund, C.
Lombard, C.
Joska, J.
Levitt, N.
Butler, C.
Cleary, S.
Naledi, T.
Milligan, P.
Stein, D.J.
Sorsdahl, K.
author_facet Myers-Franchi, Bronwyn
Lund, C.
Lombard, C.
Joska, J.
Levitt, N.
Butler, C.
Cleary, S.
Naledi, T.
Milligan, P.
Stein, D.J.
Sorsdahl, K.
author_sort Myers-Franchi, Bronwyn
building Curtin Institutional Repository
collection Online Access
description Background: In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. Methods/Design: This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios. Discussion: Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting.
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spelling curtin-20.500.11937-857122021-10-07T03:58:09Z Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial Myers-Franchi, Bronwyn Lund, C. Lombard, C. Joska, J. Levitt, N. Butler, C. Cleary, S. Naledi, T. Milligan, P. Stein, D.J. Sorsdahl, K. Science & Technology Life Sciences & Biomedicine Medicine, Research & Experimental Research & Experimental Medicine Common mental disorders Chronic disease care Integrated treatment South Africa MIDDLE-INCOME COUNTRIES PROBLEM-SOLVING THERAPY COGNITIVE-BEHAVIORAL THERAPY SOUTH-AFRICAN STRESS USE DISORDERS SUBSTANCE USE DRUG-USE ANTIRETROVIRAL THERAPY PSYCHIATRIC-DISORDERS MEASURING ADHERENCE Background: In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. Methods/Design: This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios. Discussion: Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting. 2018 Journal Article http://hdl.handle.net/20.500.11937/85712 10.1186/s13063-018-2568-9 English http://creativecommons.org/licenses/by/4.0/ BMC fulltext
spellingShingle Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Common mental disorders
Chronic disease care
Integrated treatment
South Africa
MIDDLE-INCOME COUNTRIES
PROBLEM-SOLVING THERAPY
COGNITIVE-BEHAVIORAL THERAPY
SOUTH-AFRICAN STRESS
USE DISORDERS
SUBSTANCE USE
DRUG-USE
ANTIRETROVIRAL THERAPY
PSYCHIATRIC-DISORDERS
MEASURING ADHERENCE
Myers-Franchi, Bronwyn
Lund, C.
Lombard, C.
Joska, J.
Levitt, N.
Butler, C.
Cleary, S.
Naledi, T.
Milligan, P.
Stein, D.J.
Sorsdahl, K.
Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial
title Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial
title_full Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial
title_fullStr Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial
title_full_unstemmed Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial
title_short Comparing dedicated and designated models of integrating mental health into chronic disease care: Study protocol for a cluster randomized controlled trial
title_sort comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial
topic Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Common mental disorders
Chronic disease care
Integrated treatment
South Africa
MIDDLE-INCOME COUNTRIES
PROBLEM-SOLVING THERAPY
COGNITIVE-BEHAVIORAL THERAPY
SOUTH-AFRICAN STRESS
USE DISORDERS
SUBSTANCE USE
DRUG-USE
ANTIRETROVIRAL THERAPY
PSYCHIATRIC-DISORDERS
MEASURING ADHERENCE
url http://hdl.handle.net/20.500.11937/85712