Warwick-India-Canada (WIC) global mental health group: rationale, design and protocol

Introduction The primary aim of the National Institute of Health Research-funded global health research group, Warwick-India-Canada (WIC), is to reduce the burden of psychotic disorders in India. India has a large pool of undetected and untreated patients with psychosis and a treatment gap exceeding 75%. Evidence-based packages of care have been piloted, but delivery of treatments still remains a challenge. Even when patients access treatment, there is minimal to no continuity of care. The overarching ambition of WIC programme is to improve patient outcomes through (1) developing culturally tailored clinical interventions, (2) early identification and timely treatment of individuals with mental illness and (3) improving access to care by exploiting the potential of digital technologies. Methods and analysis This multicentre, multicomponent research programme, comprising five work packages and two cross-cutting themes, is being conducted at two sites in India: Schizophrenia Research Foundation, Chennai (South India) and All India Institute of Medical Sciences, New Delhi (North India). WIC will (1) develop and evaluate evidence-informed interventions for early and first-episode psychosis; (2) determine pathways of care for early psychosis; (3) investigate the efficacy and cost-effectiveness of community care models, including digital and mobile technologies; (4) develop strategies to reduce the burden of mental illnesses among youth; (5) assess the economic burden of psychosis on patients and their carers; and (6) determine the feasibility of an early intervention in psychosis programme in India. Ethics and dissemination This study was approved by the University of Warwick’s Biomedical and Scientific Research Ethics Committee (reference: REGO-2018-2208), Coventry, UK and research ethics committees of all participating organisations. Research findings will be disseminated through peer-reviewed scientific publications, presentations at learnt societies and visual media.


Study Population
Patients with 'untreated' FEP and their carers visiting psychiatry department at respective collaborating sites, fulfilling the study inclusion/exclusion criteria will be recruited into the study. Participating patients must be aged 16 Untreated is defined as not having received anti-psychotic medication for more than 30 days since the onset of psychosis. Patients must be able to communicate in Tamil or English in Chennai, and Hindi or English in New Delhi. Study exclusion criteria are: those with overt learning disability (equivalent to IQ <70, ascertained either by previous diagnosis or detailed history from the patients and their caregivers, corroborated by observations from academic performance assessed using test scores from various subjects (such as language and mathematics), organic brain damage and epilepsy of pervasive developmental disorder.
Written informed consent will be obtained from interested and eligible participants prior to participation. Consent will also be sought from interested carers of study participants for carer-reported measures.

Study Assessment Tools
Various clinical scales will be used to assess several domains of symptom severity and patient functioning at baseline and follow-up assessments. Baseline assessment will be conducted soon after entry into the service, and follow-up assessments will be conducted at 3, 6 and 12 months.
Socio-demographic, clinical, and socio/family variables will be collected using semistructured (MRC demographic schedule) face-to-face clinical interview.
Psychopathology will be assessed using the: (i) Scale for the Assessment of Positive Rating Scale (3); and (v) Brief Psychiatric Rating Scale (BPRS) (4). Severity of illness and functioning will be measured using the Global Assessment of Functioning (GAF) Scale (5), the Social And Occupational Functioning Assessment Scale (SOFAS) (6) and 5-level EQ-5D (EQ 5 D 5L) (7). Other assessment tools that will be used in this study are: (i) The Emerging Psychosis Attribution Schedule (EPAS) to assess patient and carer attributions of symptoms in the emerging phase of a psychotic episode (8); (ii) the Nottingham Onset Schedule (NOS) to establish duration of untreated psychosis  (14); and (vii) Brief Assessment of Cognition in Schizophrenia (BACS) for neurocognition. Additionally, we will also capture data on treatment, relapse and physical health. The caregivers will be assessed on the Burden Assessment Schedule (BAS) (15). Engagement of caregivers will be encouraged to obtain accurate patient-information including patients' medical history, risk factors, family responses to illness, help-seeking and potential impact on family. The estimated time to complete the study assessments will be around 60 min -90 min. Each assessment will be conducted in two or more sessions depending on the participant's time, availability and comfort. Supplementary table 1 depicts the assessment schedule for both baseline and follow-up assessments.

Management of FEP
Following a comprehensive assessment as described above, patients with FEP will be offered the following treatment options: Antipsychotics • Oral antipsychotics in lowest possible dose taking into account of effectiveness, tolerability and patient preference.
• Depot antipsychotics may be used if adherence is a significant problem or based on patient preference. • The choice of antipsychotic medication will be discussed by the service user and healthcare professional, and decision will be made, taking into account of the views of the carer. The study team will provide more information on Before starting antipsychotic medication, the study team will undertake and record the following baseline investigations: • weight and BMI • waist circumference • pulse and blood pressure • fasting blood glucose, glycosylated haemoglobin (HbA1c), blood lipid profile and prolactin levels • assessment of any movement disorders • assessment of nutritional status, diet and level of physical activity.
• Before starting antipsychotic medication, offer the person with psychosis or schizophrenia an electrocardiogram (ECG) if: • specified in the summary of product characteristics (SPC) • a physical examination has identified specific cardiovascular risk (such as diagnosis of high blood pressure) • there is a personal history of cardiovascular disease

Psychosocial interventions
For Patients

Background
In India, over 90% of patients stay in the community with families, and in the absence of state provision, families initiate treatment, procure and supervise medicines and provide psychosocial support including opportunities for education, vocation and recreation (16). Importantly, the stress of caregiving adversely affects carer's' physical and mental health (17). In this WP, we will deliver a home-based psycho-social recovery care model, strategies for reducing carer burden, and evaluate its clinical and cost-effectiveness using a three-pronged approach (Supplementary figure 2). We will deliver a mobile application for home-based psychosocial recovery, strategies for reducing carer burden, and determine its clinical and cost-effectiveness.
In brief, first, we will conduct focus group discussions with patients with schizophrenia, their families/caregivers and mental health professionals, to gather information on their healthcare needs and expected outcomes from a home-based psycho-social care model. Second, utilizing insights from these focus groups and an extensive literature review, we will develop a 'bespoke' home-based psycho-social care model (named as SAKSHAM, meaning effort in Hindi, booklet version) aimed at improving functioning and recovery of 'difficult-to-treat' patients with schizophrenia; and at reducing carer burden.
The Saksham will have two parts: booklets and mobile app. These will be developed after conducting focussed group discussions (FGDs) with stakeholders: patients, family caregivers and mental health professionals. Based on existing evidence and themes developed from the FGDs, the domains identified for the psychosocial intervention were medication adherence, physical health monitoring, activities of daily living, instrumental activities of daily living, diet management and need for psychoeducation. Intervention package for all six target domains will be developed.
The content of the Saksham booklets will be in Hindi and English for both patients and caregivers. The content validity of the booklets will be tested by getting inputs from the stakeholders. The content of the booklets will be digitised for the Saksham mobile application. Finally, we will evaluate the feasibility and effectiveness of both the booklet version and mobile based application in a small group of patients with schizophrenia and their caregivers, and will compare against treatment as usual

Section C -Work Package 5:-Early detection using a community awareness programme (Commissioned Project)
India has a young population -over half of Indian's population are under the age of 30 years (22), with an overall mental illness prevalence rate of 10.6% and nearly 150 million Indians in need of active interventions (23). Taking into account that 80% of FEP usually occurs at a very young age ( i.e. between 16 and 30 years of age) (24) and that LMICs have predominantly young populations, it is highly likely that an overwhelming majority of people experiencing FEP live in LMIC countries such as India. However, lack of adequate mental health services in India along with other impediments to care such as stigma and lack of awareness can lead to delayed helpseeking contributing to long DUPs. A longer duration of DUP is associated with a poor treatment response, greater subsequent disability and higher mortality rates (25); therefore, timely identification and diagnosis are pivotal. India does not have standardized early detection and intervention programs for psychotic disorders. There are sporadic awareness and screening programs held in some schools and colleges. Moreover, these programs have not integrated active referral of "cases" to appropriate interventions. This work package therefore aims to increase mental health literacy of teachers and students; to use a web-based screening tool to detect youth who could benefit from mental health services; and to refer such youth to appropriate services.

Intervention
We will develop mental health training modules for teachers and mental health awareness modules for students. The training manual for teachers will contain information on mental illness, especially psychosis and is aimed to create awareness about the early signs and symptoms of psychosis to facilitate early referrals to clinical care. Data on Knowledge, Attitude and Practice (KAP) of the teachers and students will be obtained at baseline, month 12 and month 24. Training for teachers include one half day session (4 hours) and three subsequent booster sessions (1 hour) in threemonth intervals. Students will be provided education on mental healthone half day session (4 hours). Voluntary mental health screening tool with the PHQ-9, GAD-7 and CAPE-P15 will be made available to all students through web-based applications and mobile applications. The overall research methodology is depicted in supplementary   figure 3 and for the list of study instruments, see supplementary Table 4. To obtain baseline referral patterns and available resources in the neighborhood To create a form for assessment of Knowledge, Attitude and Practice (KAP) on mental health and illness for teachers ans students To develop standardized modules for mental health education for students and identification and referral of mental illness in students for teachers To develop and validate an App-based screening tool for identification of mental health problems in youth by providers in target institutitions To obtain the Baseline KAP on mental health and illness in students and teachers in schools and colleges To deliver standardized learning modules related to various aspects of mental health in the youth to students and teachers Universal screening for mental illness in students through App-based screening tool To study the changes in KAP of providers in the target institutions To study the changes in referrals for mental health problems in target institutions To study the replicability of the learning modules as administered by providers in the target institutions To study the cost effectiveness of the administration of learning modules BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s)