Can General Practitioners manage mental disorders in primary care? A partially randomised, pragmatic, cluster trial

BackgroundFor a decade, experts have suggested integrating mental health care into primary care to help bridge mental health Treatment Gap. General Practitioners (GPs) are the first port-of-call for many patients with mental ill-health. In Indonesia, the WHO mhGAP is being systematically introduced to its network of 10,000 primary care clinics as an add-on mental health training for pairs of GPs and Nurses, since the end of 2015. In one of 34 provinces, there exists an integrated care model: the co-location of clinical psychologists in primary care clinics. This trial evaluates patient outcomes among those provided mental health care by GPs with those treated by clinical psychologists in primary care.MethodsIn this partially-randomised, pragmatic, two-arm cluster non-inferiority trial, 14 primary care clinics were assigned to receive the WHO mhGAP training and 14 clinics with the co-location framework were assigned to the Specialist arm. Participants (patients) were blinded to the existence of the other pathway, and outcome assessors were blinded to group assignment.All adult primary care patients who screened positive for psychiatric morbidity were eligible. GPs offered psychosocial and/or pharmacological interventions and Clinical Psychologists offered psychosocial interventions. The primary outcome was health and social functioning as measured by the HoNOS and secondary outcomes include disability measured by WHODAS 2.0, health-related quality of life measured by EQ-5D-3L, and resource use and costs evaluated from a health services perspective, at six months.Results153 patients completed the outcome assessment following GP care alongside 141 patients following Clinical Psychologists care. Outcomes of GP care were proven to be statistically not inferior to Clinical Psychologists in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Economic analyses indicate lower costs and better outcomes in the Specialist arm and suggest a 50% probability of WHO mhGAP framework being cost-effective at the Indonesian willingness to pay threshold per QALY.ConclusionGeneral Practitioners supported by nurses in primary care clinics could effectively manage mild to moderate mental health issues commonly found among primary care patients. They provide non-stigmatising mental health care within community context, helping to reduce the mental health Treatment Gap.Trial registrationClinicalTrials.gov NCT0270049

Strengthening medical abortion in South Africa

Access to safe, legal abortion services is an important public health measure to address morbidity and mortality from unsafe abortion. To expand access and strengthen medical abortion provision in South Africa, evidence is needed on the safety, effectiveness, feasibility and acceptability of task sharing strategies and the implementation of evidence-based regimens. This research aims to: (a) evaluate the safety and acceptability of task sharing gestational age estimation for women seeking abortion, (b) determine the effectiveness and acceptability of text messaging on mobile phones to support women self-managing medical abortion, (c) evaluate the feasibility, safety and acceptability of self-assessment of medical abortion completion using mobile phones alone or in combination with a low-sensitivity pregnancy test, and (d) document clinical outcomes and women's experiences following the introduction of mifepristone into second trimester medical abortion services. Published or submitted papers included in this thesis are from four prospective studies evaluating interventions and interviewing women and health care workers in South African public sector and non-governmental clinics between 2011 and 2015. The first paper establishes that last menstrual period is sufficiently accurate to estimate gestational age in selected women (97%) and has potential to be task shared with community health workers or women themselves. The second paper reports reduced anxiety (p=0.013) and better preparedness (p=0.016) for self-managing abortion symptoms among women receiving automated text messages (compared to those receiving standard care). The third and fourth papers show that mobile phones are a feasible modality for self-assessment for most women (86%), but that clinical history needs to be combined with an appropriate pregnancy test to detect incomplete or failed procedures. Self-assessment using a low-sensitivity pregnancy test is preferred by most women (98%) to in-clinic follow-up, and providing a guided demonstration on the use of a low-sensitivity pregnancy test does not significantly impact on the accuracy of self-assessed abortion outcome compared to simple verbal instructions (88% vs. 85% accuracy; p=0.449). The fifth paper documents successful self-administration of mifepristone, a higher 24-hour abortion rate (93% vs 77%; p<0.001), and greater acceptability following the introduction of mifepristone into second trimester abortion care, compared to historic cohorts receiving misoprostol only. The thesis concludes that supported self-management and task sharing can strengthen medical abortion provision in South Africa. Research evaluating task sharing of medical abortion care has potential to inform similar approaches for other health care services

Can General Practitioners manage mental disorders in primary care? A partially randomised, pragmatic, cluster trial.

BACKGROUND:For a decade, experts have suggested integrating mental health care into primary care to help bridge mental health Treatment Gap. General Practitioners (GPs) are the first port-of-call for many patients with mental ill-health. In Indonesia, the WHO mhGAP is being systematically introduced to its network of 10,000 primary care clinics as an add-on mental health training for pairs of GPs and Nurses, since the end of 2015. In one of 34 provinces, there exists an integrated care model: the co-location of clinical psychologists in primary care clinics. This trial evaluates patient outcomes among those provided mental health care by GPs with those treated by clinical psychologists in primary care. METHODS:In this partially-randomised, pragmatic, two-arm cluster non-inferiority trial, 14 primary care clinics were assigned to receive the WHO mhGAP training and 14 clinics with the co-location framework were assigned to the Specialist arm. Participants (patients) were blinded to the existence of the other pathway, and outcome assessors were blinded to group assignment. All adult primary care patients who screened positive for psychiatric morbidity were eligible. GPs offered psychosocial and/or pharmacological interventions and Clinical Psychologists offered psychosocial interventions. The primary outcome was health and social functioning as measured by the HoNOS and secondary outcomes include disability measured by WHODAS 2.0, health-related quality of life measured by EQ-5D-3L, and resource use and costs evaluated from a health services perspective, at six months. RESULTS:153 patients completed the outcome assessment following GP care alongside 141 patients following Clinical Psychologists care. Outcomes of GP care were proven to be statistically not inferior to Clinical Psychologists in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Economic analyses indicate lower costs and better outcomes in the Specialist arm and suggest a 50% probability of WHO mhGAP framework being cost-effective at the Indonesian willingness to pay threshold per QALY. CONCLUSION:General Practitioners supported by nurses in primary care clinics could effectively manage mild to moderate mental health issues commonly found among primary care patients. They provide non-stigmatising mental health care within community context, helping to reduce the mental health Treatment Gap. TRIAL REGISTRATION:ClinicalTrials.gov NCT02700490

Quality of life and clinical outcomes in Type 2 diabetes patients at the primary care clinics of the West Virginia University Hospital

This study examines relationships between quality of life (QoL) and clinical outcomes, specifically A1C, in Type 2 diabetes patients. Type 2 diabetes patients at the outpatient clinics of a university hospital completed the SF-12 and the Audit of Diabetes Dependent Quality of Life (ADDQoL), and this was merged with a retrospective collection of his/her clinical and utilization data, including A1C. Usable response rate was 44.3% (n = 385). Mean A1C of respondents was 7.2 (+1.4), mean diabetes duration was 10.2 (+9.1), and 62.1% were obese. Only ADDQoL scores showed significant correlation with A1C (r = -0.19, p \u3c 0.000). Hierarchical regression models were used to explain the effect of A1C on QoL controlling for demographics and clinical variables. A1C was not a significant predictor in any regression model, although univariate analyses indicated significantly lower ADDQoL and SF-12 PCS in the group with A1C \u3e 7.0. Obesity was a significant predictor in models explaining only the PCS and MCS scores. These results support complementary use of generic and disease-specific QoL measures in Type 2 diabetes populations. Patient\u27s perceptions of their own life may differ from what a biomedical measure like A1C suggests

Tracking progress toward achieving Universal Health Coverage:Developing a methodology to estimate Effective Coverage across countries

The Universal Health Coverage (UHC) is a movement that promote health for all and is included among the Sustainable Development Goals. The World Health Organization (WHO), the World Bank and other institutions have proposed ‘effective coverage’ as an indicator for tracking progress toward UHC. Effective coverage is an indicator that combine two parameters: the coverage of a healthcare intervention and the quality of it. According to Shengelia et al.’s framework for effective coverage, quality must be measured through the health gains associated with the utilization of a healthcare service. However, none of these organizations above mentioned have properly measured effective coverage due to the lack of information about the quality of healthcare services.In a systematic scoping review aimed to identify the use of effective coverage in the scientific literature, I found 128 studies preforming 246 assessments of healthcare interventions in 138 countries – 81% low and middle-income countries. Only one assessment included health gains into the parameter of quality. The aim of this thesis is to develop a practical procedure to estimate the effective coverage considering health gains.Calculating health gains is related with valuating health states. There are two main approaches for valuing health states: those that look for social preferences or utilities (e.g. standard gamble, time-trade off, person -trade-off), and those that look for a direct measure of the health status or disability (e.g. paired comparison). The first approach produces ‘health-utility weights’, and the second approach produces ‘disability weights’. Traditionally, disability weights are used for calculating disability-adjusted life years (DALY) a measure of burden of disease, while health-utility weights are used for calculating quality-adjusted life years (QALY) a measure used in cost-effectiveness analysis.Using data from the Chilean National Health Survey 2009-2010 (Ch-NHS 2009-2010) and the Health States Description questionnaire included in that survey, I calculated a latent variable of disability. I argue that through a regression model applied to a latent variable of disability or health-states utilities, it is possible to estimate disability weights (or health-utility weights) for different health states associated with a disease, adjusting by comorbidities and other confounders. The attributable fraction encompasses a family of epidemiological estimators that combine relative and absolute effect sizes. Attributable fractions have been used mainly for exploring the effect of risk factors on diseases. Using the attributable fraction metrics applied to a continuous outcome such us a latent variable of disability or health-state utility, I present a new way of calculating the burden of disability (or the loss of health-state utilities) associated with diseases. This methodological proposal would be more straightforward to be carried out than the standard methodological alternative (i.e. years lived with disability, a component of DALYs). Two approaches to calculate the burden of disability attributable to diseases are presented: the population average-level and the individual-level.I also argue that the procedure to calculate the burden of disability (or loss of health-state utilities), described above, can be used to estimate effective coverage. I define effective coverage as the fraction of avoidable disability (or loss of health-state utilities) attributable to a disease, avoided by using a healthcare intervention. I also propose a definition for other related indicators: health benefit, quality, relative effective coverage (r-EC) and absolute effective coverage (a-EC). While effective coverage results from the combination of the coverage and quality, the r-EC results from the combination of the coverage and the health benefit (i.e., effectiveness). a-EC is defined as the fraction of the disability attributable to a disease in the entire population that is avoided by the healthcare intervention. This indicator is suitable to be combined with costs associated with healthcare services. The procedure to estimate these indicators is tested initially using data from the Ch-NHS 2009-2010 applied to the case of treatment for depressive disorder.A more comprehensive appraisal of the performance of the procedure to calculate effective coverage and other indicators is also carried out using cross-sectional data from WHO study on global ageing and adult health (SAGE), Wave 1, undertaken between 2007-2010 in China, Ghana, India, Mexico, the Russian Federation, and South Africa. Three healthcare interventions were explored: treatment for depressive disorder, treatment for hypertension and treatment for osteoarthritis.The methodological proposal for calculating effective coverage achieves estimating health gains into a parameter of quality using cross-sectional data. Among the strengths of the proposal developed in this thesis I highlight: (1) the concept of effective coverage is expanded through new indicators; (2) the procedure is straightforward to be implemented; (3) it depends on only one source of information, which ensures consistency between parameters; and (4) it can be used indistinctly with different outcomes: disability or health-state utilities.However, its main limitation is that the effect size attributable to the healthcare intervention is weak because the procedure proposed in this thesis is based on cross-sectional data. To improve the methodological proposal of this thesis, I highlight the following challenges for future research: (1) exploring other procedures to obtain a better proxy of the effect size of healthcare interventions using cross-sectional data (e.g. propensity score matching, instrumental variables); (2) including fatal consequences; (3) including an equity perspective in the outcome; and (4) exploring combining a-EC with the costs of healthcare interventions.Regarding tracking progress toward UHC, I argue that a-EC would be a more adequate indicator than effective coverage. a-EC includes in a single metric the effectiveness of healthcare services, the coverage of it, the disability associated with a disease, and the prevalence of such disease. Moreover, a-EC can be added across different healthcare- services in a simpler way than with other indicators. Finally, it can be combined with the cost of the healthcare interventions, which is appropriate to inform decision makers

Complex Interventions to Address Chronic Respiratory Diseases and Tobacco Smoking in a Lower-Middle Income Setting

Chronic respiratory disease (CRD), including chronic obstructive pulmonary disease (COPD), asthma, and less common respiratory diseases, is one of the four major noncommunicable diseases worldwide. Tobacco smoking is a major, avoidable risk factor for CRD. In low- and middle-income countries, there are important barriers preventing people affected by CRD from gaining access to effective, evidence-based prevention and disease management. In Vietnam, little is known about the gap between evidence-based practice and actual clinical management for CRD and cigarette smoking. This thesis aims to assess the current practice for CRD and tobacco smoking in the Vietnamese healthcare system and to evaluate the feasibility of two interventions to reduce the burden of CRD and tobacco smoking. The first part of the thesis includes two cross-sectional studies conducted at all four levels of healthcare facilities in Vietnam. In the first study, I used a syndromic approach to assess patients visiting healthcare facilities due to respiratory symptoms. The findings suggested that COPD and asthma were often misdiagnosed and more than half of patients with the diseases did not receive maintenance inhaled medicines for airways disease. In the second study, we found a high prevalence of current smoking among male patients seeking healthcare. The majority of those who attempted to quit had never used any evidence-based method to help them quit. The second part of the thesis reports pilot studies for two trials that were conducted in three rural district hospitals in Hanoi. The first trial assessed the feasibility of a novel stepped approach to treatment of patients with undifferentiated CRD (asthma and/or COPD) using inhaled budesonide-formoterol. Our data collected over 12 months follow-up period suggested that this intervention is feasible in a rural setting in Vietnam. The second trial focused on tobacco smoking and the interventions included the implementation of smoke-free hospital policy, brief advice from doctors, and follow-up counselling phone calls and text messaging. We found a high rate of self-reported smoking cessation. However, many of the participants did not consent to biochemical verification of their quit status, limiting the interpretation of the trial. Finally, I conducted a process evaluation to assess various aspects of implementing the intervention for CRD that may affect patients’ outcomes. The process evaluation shows barriers and challenges to implementing the components of the intervention, such as insufficient inhaler education from pharmacists and underutilisation of management plan by patients. The findings from this process evaluation will help to improve the implementation of interventions for COPD and asthma in Vietnam

A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation

Background: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Aim: Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation. Design: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Setting: Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant\u27s own home or at a local NHS facility, and by telephone. Participants: Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Intervention: The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral. Main outcome measures: Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Results: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference \ua3770.24, 95% confidence interval -\ua327.91 to \ua31568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants\u27 lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive-behavioural approach intervention, but high-intensity cognitive-behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. Conclusions: The tailored cognitive-behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Trial registration: This trial is registered as ISRCTN59537391. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/146/02) and is published in full in Health Technology Assessment; Vol. 28, No. 1. See the NIHR Funding and Awards website for further award information.People with long-standing lung problems, such as chronic obstructive pulmonary disease, often also have anxiety and depression, which further reduces their quality of life. Two existing treatments could help. Pulmonary rehabilitation (a programme of exercise and education) improves both the physical and mental health of people with chronic obstructive pulmonary disease. Cognitive–behavioural therapy (a talking therapy) may reduce anxiety and depression. The TANDEM [Tailored intervention for Anxiety and Depression Management in chronic obstructive pulmonary disease (COPD)] intervention linked these two treatments by providing talking therapy based on cognitive–behavioural therapy during the waiting time following referral for pulmonary rehabilitation. The TANDEM treatment was delivered by respiratory healthcare professionals (e.g. nurses or physiotherapists) trained to deliver the talking therapy in six to eight weekly sessions. The sessions were conducted in the participant’s home (or another convenient location), with brief telephone support during the pulmonary rehabilitation. Of 423 participants recruited to the study, 242 participants received TANDEM talking therapy and 181 participants received usual care (including a referral to pulmonary rehabilitation). We measured mental health, quality of life, social life, attendance at pulmonary rehabilitation and healthcare use in both groups at 6 and 12 months. Forty-three carers joined the study and we assessed their mental well-being. We interviewed patients, carers and health professionals to find out their views and experience of the TANDEM treatment. We also examined whether or not the TANDEM treatment was good value for money. The TANDEM treatment did not improve the mental or the physical health of people with chronic obstructive pulmonary disease. In addition, the TANDEM treatment cost the NHS an extra \ua3770 per patient, which was not good value for money. The TANDEM treatment was well received, and many participants told us how it had helped them. Heath-care professionals noted how participants did not just have chronic obstructive pulmonary disease, but were coping with many physical, mental and social problems. The TANDEM intervention was not effective and, therefore, other strategies will be needed to help people with chronic obstructive pulmonary disease and mental health problems live with their condition

“Beyond Black and Blue” Intimate Partner Violence as a form of Family Violence Against Women and Common Mental Disorders in Mumbai informal settlements

The thesis investigates family violence against women living in informal settlements in Mumbai, and its associations with mental health. Globally and in India, a third of women experience violence from an intimate partner in their lifetime, an estimate that would be higher if it accounted for other perpetrators within the family. The thesis includes qualitative and quantitative studies. The quantitative study was a survey of 482 women that investigated violence in detail, including its types, perpetrators, and timescales. Symptoms of common mental disorders were assessed with the General Health Questionnaire-12 and levels of self-esteem with the Rosenberg self-esteem questionnaire. Associations were explored through multivariable linear and ordinal logistic regression, adjusted for socio-demographic covariates. The qualitative study included semi-structured individual interviews and focus group discussions with 33 women, exploring narratives of violence, responses, coping, and resilience. Analysis took a Framework approach. The prevalence of violence was high - 44% over a lifetime - but in line with other national surveys. More women reported emotional violence than other forms. In-laws were the main perpetrators of emotional and economic violence, and husbands of physical and sexual violence. Emotional violence showed the strongest positive association with symptoms of common mental disorders and lower self-esteem. In the qualitative study, women described patterns of violence that often included the marital family as perpetrators. Responses to violence included feelings, thoughts, and behaviours ranging between active and passive. Women described a ceiling of tolerance that influenced their responses to violence and was informed by their context and previous experiences. The thesis adds to the current literature by exploring violence in detail and combining survey data with women’s narratives. It highlights the need to further investigate family violence and emotional violence, particularly in other South Asian settings where patterns of patrilocal residence and joint families are common

eHealth in Chronic Diseases

This book provides a review of the management of chronic diseases (evaluation and treatment) through eHealth. Studies that examine how eHealth can help to prevent, evaluate, or treat chronic diseases and their outcomes are included

A study of two models of primary mental health care provisions in Yogyakarta, Indonesia

Background The World Health Organization (WHO) defines health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. Despite its importance, mental health provisions are often limited. In 2015, Indonesia had only 773 psychiatrists for 250 million residents. This shortage of specialist mental health professionals is shared by most Low- and Middle-Income Countries (LMICs) and is reflected in the Treatment Gaps in this region indicating the very small proportion of people who receive adequate mental health care for their needs. While the median worldwide Treatment Gap for psychosis is 32.2% (Kohn et al., 2004), in Indonesia it is more than 90%. Experts suggested integrating mental health care into primary care, to help bridge this gap (Mendenhall et al., 2014). The systematic introduction of the World Health Organization Mental Health Gap Action Programme into primary care clinics across Indonesia and the presence of a 15-year-old co-location of Clinical Psychologists in Yogyakarta province’s primary care clinics presented an opportunity to assess the clinical and cost-effectiveness of both frameworks. Methods This research (“the trial”) set out to develop an approach, and then implement it, to compare the adapted WHO mhGAP framework with the existing specialist framework within primary mental health services in Yogyakarta, Indonesia, through a pragmatic, two-arm cluster randomised controlled non-inferiority trial. This design enabled an examination of patients derived from whole populations in a ‘real world’ setting. The trial involved two phases: a pilot study in June 2016 with the objectives to refine data collection procedures and to serve as a practice run for clinicians involved in the trial; as well as a substantive trial beginning in December 2016. The 12-item General Health Questionnaire (GHQ-12) was established as a ‘fairly accurate’ screening tool using a Receiver Operating Curve study. Using the GHQ scoring method of 0-0-1-1, a threshold of 1/2 was identified for use in clinical setting, i.e. the context of the trial. The primary outcome was the health and social functioning of participants as measured by the Health of the Nation Outcome Scale (HoNOS) and secondary outcomes were disability as measured by WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality of life as measured by European Quality of Life Scale (EQ‐5D-3L), and cost of intervention evaluated from a health services perspective, which aimed to determine the clinical effectiveness and cost-effectiveness of both frameworks at six months. Results During the recruitment period, 4944 adult primary care patients attended 27 participating primary care centres. Following screening (n=1484) and in-depth psychiatric interviews (n=394), 174 WHO mhGAP arm and 151 Specialist arm participants received a formal diagnosis and were recruited into the trial. The number of required participants per treatment arm, to provide statistical power of 0.80 and statistical bilateral significance value of 0.05 was estimated to be 96. A total of 153 participants of the WHO mhGAP arm and 141 of the Specialist arm were followed-up at six months, representing 90.8% of all participants diagnosed. At follow-up, 82% (n=126) participants of the WHO mhGAP arm indicated they had attended at least one treatment session during the trial, significantly more than in the Specialist Arm (69%; n=97), 2 = 7.364, p=0.007. The WHO mhGAP arm was proven to be statistically not inferior to the Specialist arm in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Cost-effectiveness analyses show that the Specialist arm was dominant for a unit of improvement in patient outcomes at six months. While the framework is more expensive for the Health System, participants in the Specialist arm were found to have larger improvements. Conclusion Given that both frameworks yielded positive patient outcomes, there is no immediate need to increase the absolute number of specialist mental health professionals in community psychiatry (i.e. replicate the specialist framework outside Yogyakarta). As most psychologists and psychiatrists in Indonesia reside in large cities, the current systematic roll-out of the adapted WHO mhGAP framework might address the need to strengthen non-stigmatising mental health care within community contexts, reflecting the preferences of primary care patients. In districts or provinces which could afford the additional cost, however, the Specialist framework was shown to be better at improving patient outcomes than the adapted WHO mhGAP framework. Existing resources for specialist care can be arranged in a hub-and-spoke (step-up care) model where higher-level interventions are provided for those with greater needs. The proposed model would free-up resources for advanced clinical training of the specialist workforce in key areas of need while keeping specialist services accessible. Trial Registration This trial has been registered with clinicaltrials.gov since 25 February 2016, NCT02700490. Ehical Standards Full ethics approval from the University of Cambridge, UK was received on 15 December 2015 (PRE.2015.108) and from Universitas Gadjah Mada, Indonesia on 14 April 2016 (1237/SD/PL.03.07/IV/2016). A condition of ethics approval from the University of Cambridge is that the investigator is covered by indemnity insurance and that participants are insured for the period of their participation. This was provided by the University of Cambridge Trial Insurance Office (609/M/C/1510). Ethics approval from all the clusters was not required as each cluster (Puskesmas) is a local GP surgery which does not have its own ethics committee. Instead, approval to conduct research at the province of Yogyakarta including all five districts: Kota Yogyakarta, Sleman, Gunung Kidul, Kulon Progo, Bantul Districts was obtained from the Provincial Government Office (070/REG/V/625/5/2016) following ethics approvals. Written consent to participate was obtained from clinicians taking part as well as all patient-participants.Gates Cambridge Scholarshi