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

Abstract

BackgroundIn 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/DesignThis 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.DiscussionStudy findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting.Trial registrationPan African Clinical Trials Registry, Trial registration number: ACTR201610001825403. Registered 17 October 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2568-9) contains supplementary material, which is available to authorized users.

Assessing capability for implementing mental health counselling within primary care facilities in a middle‐income country: A feasibility study

“…This manuscript complies with the Consolidated Criteria for Reporting Qualitative Research (Tong, Sainsbury, & Craig, ; see Data ). As part of a larger study aimed at integrating mental health care into chronic disease services, known as project MIND (Myers, Lund, et al, ), we conducted observations of chronic disease service delivery at PHC clinics in the Western Cape Province. Project MIND is a cluster randomized controlled trial (Trial registration number: PACTR201610001825403) that is comparing two different approaches to integrating mental health counselling into HIV and diabetes care, two highly prevalent chronic conditions in South Africa.…”

“…Project MIND is a cluster randomized controlled trial (Trial registration number: PACTR201610001825403) that is comparing two different approaches to integrating mental health counselling into HIV and diabetes care, two highly prevalent chronic conditions in South Africa. The choice of these chronic conditions was influenced by the high prevalence of untreated common mental disorders in these patient populations and their impact on treatment adherence and outcomes (Myers, Lund, et al, ).…”

Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa

“…The means and standard deviation of provider fidelity at each session will be calculated. Average session fidelity will be compared with similar lay counselor delivered interventions implemented in SA and peer-delivered interventions in the US; similarly, the percentage of patients participating and retained in the intervention will be described and compared with similar pilot studies [23,59].…”

Brief psychotherapy administered by non-specialised health workers to address risky substance use in inpatients with multi-drug resistant tuberculosis: A feasibility and acceptability study

“…17.5 (15-24) versus 6 (6-8), Z = 6.206, p < 0.0001). Depressive symptomatology improved, with the median (IQR) CES-D score significantly lower post-intervention [23.5 (18-34) vs. 17 (13)(14)(15)(16)(17)(18)(19)(20)(21)(22), p < 0.01].…”

“…These interventions are typically based on cognitive-behavioural and motivational interviewing techniques. A number of studies have been conducted in South Africa investigating the effectiveness of SBI among patients presenting to emergency centres (15), women receiving antenatal care (16), people receiving treatment for human immunodeficiency virus (HIV) and other chronic diseases in primary care settings (17)(18)(19), and hospitalised inpatients at a district-level hospital (20) and TB patients (12,13).…”