Innovation summary

Approximately 5-8% of the world’s population suffer from a Severe Mental Illness (SMI) presenting a major challenge to healthcare systems worldwide. SMI causes significant distress to affected people, families, and wider communities, generating high costs through loss of productivity and ongoing healthcare use. Within LMICs, an estimated 69%-89% of people with SMI experience a treatment gap, adding to other significant social inequalities [1]. This treatment gap is most pronounced for people with psychosis, particularly chronic psychosis, where 75% of all individuals fail to receive adequate care, despite a high financial burden and reduced quality of life (QoL) [2] 

This research project seeks to explore, adapt, and test a low-cost, generic approach (DIALOG+), which makes use of existing resources to improve community-based care for people with psychosis and reduce the need for institutionalisation. The programme of research, which is funded by the National Institute of Health Research (NIHR), includes five work packages aiming to develop, test and implement DIALOG+. The work packages are outlined within this protocol.  

Impact summary

  • Situational analysis conducted on psychosocial interventions to improve community-based care for people with psychosis 
  • DIALOG+ Pilot completed with 33 people with psychosis and 8 clinicians 
  • Intervention adaptation including translation into the local language, revision of training SOPs and participant recruitment 
  • Cluster Randomised Controlled Trial initiated at 3 clinical sites 

“l feel that for the first time – I have said all that has been bothering me in terms of my functioning… you have spoken to me and not my husband… that makes me feel even better”

(43 year old female in India) 

Innovation details

SMI causes significant distress to affected people, families and wider communities, generating high costs through loss of productivity and ongoing healthcare use. The burden is greatest in low- and middle-income countries (LMICs), where there is a lack of financial resources and qualified staff to provide extensive specialised services [1]. Lack of mental health services and widespread poverty means that mental health issues often remain undiagnosed, misdiagnosed, or untreated within both countries. In India, the estimated lifetime prevalence of mental disorders is 13.9%, with inadequate infrastructure, financial and human resources resulting in a ratio of 3 psychiatrists per million people [3]. The treatment gap is calculated at 70-75% for people with psychosis. The prevalence of mental health disorders in Pakistan is reportedly up to 34%, and inadequate attention to mental health in the public sector has resulted in an estimated ratio of 2-3 psychiatrists per million people [4]. 

Care for people with psychosis in India and Pakistan predominantly exists in conventional inpatient facilities, where people can stay for long periods removed from their social context and without effective psychosocial interventions. Lack of qualified staff limits the ability to provide services used in high-income countries (HICs) such as multi-disciplinary teams or specialised psychological treatments (e.g., Cognitive Behavioural Therapy) [5]. LMICs therefore need effective, appropriate and low-cost forms of care that utilise and strengthen existing personal and social resources available to individuals, their families and communities. Where investment has occurred, it has often focused on the detection of SMI, and/or on early intervention. Such approaches are promising, but fewer research activities and resources are allocated to those with chronic psychosis, where community-based interventions are severely limited. Reducing the treatment gap for individuals with psychosis by providing low-cost, effective interventions is an urgent priority.  

The overall aim of the project is to improve the quality of community-based care for patient with psychosis in India and Pakistan by adapting and testing an evidence-based, low-cost and generic approach (DIALOG+), and up-scaling through the use of participatory arts methodologies and community engagement. To achieve this, we aim to: 

  1. Adapt DIALOG+ to ensure appropriateness to the local context; 
  2. Test the feasibility, acceptability, effectiveness and cost-effectiveness of the intervention in improving QoL, and secondary outcomes (symptoms, treatment satisfaction, physical health, social situation) for people with psychosis; 
  3. Develop an implementation toolkit to aid wider dissemination and upscale; 
  4. Build the capacity of local researchers and services through a programme of capacity-building and knowledge exchange; 
  5. Engage with the local community, using digital and social media, and innovative arts-based approaches;  
  6. Develop a model for user involvement in research, including establishing Lived Experience Advisory Panels (LEAP). 

 


 

Intervention details: 

DIALOG+ is an app-mediated intervention that has been shown to improve mental health outcomes, including quality of life, for people with SMI. During each meeting with their clinician, patients begin by rating their life and treatment satisfaction and state whether they need additional help in each area. As DIALOG+ is an app-based intervention, the results are stored and can be compared with previous ratings. Finally, the intervention helps clinicians provide solutions for concerns raised by the patient. Although this intervention has been shown to be effective within high income countries such as the UK, it requires cultural adaptation and validation within India and Pakistan for it to be implemented as part of routine care.   

DIALOG+ consists of a patient-centred assessment whereby the clinician invites the patient to rate their satisfaction with 11 different life domains and treatment aspects. This is followed by a four-step solution-focused approach to identify the patient’s resources and develop solutions to deal with the patient's concerns. The intervention is available as an app and makes use of a tablet computer (e.g. ipad or android device) within routine clinical meetings. Clinicians will receive training from the researchers in how to use the intervention, including how to support patients who are unfamiliar with a tablet computer.  

 


 

PIECEs work packages: 

Work package 1. To assist with the adaptation, the context in which the intervention will be delivered, and the readiness for services to adopt the approach, will be assessed through a small-scale situation analysis. This will be followed by a mixed method approach consisting of a small-scale pilot of the existing DIALOG+ intervention and participatory focus groups with different participant groups e.g. patients, carers, clinicians etc.  

Work package 2. To assess the acceptability and feasibility of the adapted DIALOG+, we are now recruiting participants into a cluster randomised controlled trial at three sites (1) SCARF outpatient clinic (Chennai, India); (2) Jinnah Postgraduate Medical Centre and (3) Karwan-e-Hayat (Karachi, Pakistan).  

Work package 3. A qualitative process evaluation will identify barriers and facilitators to implementation alongside two types of participatory workshops, SALT and Quality Improvement.  

Work package 4. Throughout the programme, we will enhance service and research-capacity by developing a critical mass of skilled individuals to sustain research activities.  

Work package 5. Running throughout we will conduct a participatory arts-based project to interact with local communities, give voice to people with psychosis, and promote new understandings for researchers and service users. 

Participatory Arts Research: 

To engage stakeholders and give voice to people with psychosis, a participatory arts-based project is being implemented utilising different arts-based methods including Theatre of the Oppressed (TO) to interact with local communities in both India and Pakistan. Working alongside the local arts organisations in both countries, people with lived experience of psychosis, family members, and the wider community will be invited to participate in physical exercises, games and drama techniques designed to activate participants’ critical engagement, stimulating public participation in key social debates. This will help raise the profile of the project, involve individuals who would not usually participate in research, and provide a lasting resource for organisations within both India and Pakistan. 

Key drivers

A. Organisational readiness and Involvement of clinicians was a facilitator as a range of different clinicians (e.g. psychiatrists, social workers, psychologists) showed interest and perceived benefit in implementing DIALOG in their practice 

B. People with psychosis did not feel technology or the use of a device as a barrier, instead reported that it helped them felt heard as clinicians were giving them additional time 

C. Clinicians shared that they were able to keep track of progress as everything is recorded digitally as well as discussions on DIALOG+ domains helped to capture a holistic picture which later on helped update clinical diagnosis or identify areas of need 

Challenges

A. Some clinicians reported using the tablet for the DIALOG+ App a barrier where they felt that having a tab during a session affected the flow of the session and influenced nonverbal communication as it decreased eye-contact. Additionally, some clinicians were enrolled with new patients for the study, rapport was considered to be a barrier during initial sessions  

B. Attrition in clinician enrollment due to change in jobs or time constraints is an ongoing challenge to the overall RCT recruitment  

C. Patients are not able to visit the clinical site frequently due to financial challenges, professional priorities, time poverty, commitments of caregivers therefore if a session gets missed, it needs to be rescheduled at the time of their next visit which is typically in a month 

Continuation

Following completion of the RCT and process evaluation, participatory workshops (including Quality Improvement (QI) and SALT), will be conducted to support wider upscale and implementation. Workshops will take place with community members, clinicians working in local services, regardless of professional background plus service managers and hospital directors. 

Partners

Arts Partners: 
Evam and Training Sideways (India) 
Interactive Resource Centre (Pakistan) 

Clinical Partners:  
Jinnah Postgraduate Medical Centre (Pakistan) 
Karwan-e-Hayat (Pakistan) 
 
Research Partners: 
Queen Mary University of London 

Aga Khan University Hospital (Pakistan) 
London School of Economics (UK) 
Warwick University (UK) 







 

FUNDERS

NIHR UK 

Evaluation methods

The DIALOG+ intervention is being evaluated for effectiveness and cost-effectiveness through a cluster randomised controlled trial (RCT), a process evaluation and a nested economic component delivered over 6 months (primary outcome analysis at 6 months post-randomisation), with a further 6-month implementation phase included (12 month post-randomisation).  

For the cluster RCT, 14 clinicians (mental health professionals) are being recruited from the outpatient clinic at each of the included clinical sites in each country. Our aim is to recruit, on average, 15 patients with psychosis per mental health clinicians. To achieve this, we will aim to recruit up to 18 patients per clinician, thus allowing for some clinicians to have a smaller number should they have fewer eligible patients on their caseload.  

Randomisation will be conducted after the recruitment of 15 patients and their clinician. Clinicians randomised to the intervention will then use DIALOG+ and those who are randomised to the active control group will use the DIALOG Scale with the recruited patients during their routine outpatient meetings, once per month for a 6-month period.  

RCT assessments will consist of socio-demographics, quality of life (MANSA); hospitalisation rates; psychiatric symptoms (BPRS); negative symptoms (SANS); objective social situation (SIX); therapeutic alliance (HAS); health-related QoL (EQ-5D-5L); caregiver burden (BAS) and service use (CSRI).  

The process evaluation will make use of routinely collected implementation data (which is stored on the tablets) and qualitative interviews with trial participants to understand the barriers and facilitators of implementation, and assess the reach of the intervention, including which clinicians and patients are most likely to adopt and/or benefit from the approach.

Cost of implementation

An economic evaluation is being conducted alongside the DIALOG+ cluster RCT with the aim to inform decision-makers in India and Pakistan about the incremental societal cost associated with health outcomes for replacing routine management of psychosis with DIALOG+.  

The economic evaluation will collect data on service costs and health outcomes (EQ-5D-5L) to generate cost-effectiveness evidence on how DIALOG+ will impact the resources of health systems, which will be a key component when developing implementation plans for wider upscale and dissemination. 

Impact details

  • Completed DIALOG+ pilot with 33 people with psychosis and 8 clinicians. Post-pilot interviewed on experience and feasibility informed local adaptations  
  • Intervention adaptation to local context: 
    • Translation of the DIALOG+ app into local languages 
    • Training videos created to showcase how DIALOG is used in a clinical setting 
    • Handouts of the manual are given to the trained clinicians for their reference and locally appropriate examples for the 4-step approach included  
    • Inclusion of caregivers of enrolled RCT participants to explore the impact of DIALOG+ on caregiver burden 
  • Cluster RCT initiated at 3 clinical sites; enrolment and randomisation of 8 clusters complete (1 cluster includes 15 people with psychosis and their consulting clinician) and active recruitment of 20 clusters pending across the sites. 
  • Lived Experience Advisory Panels (LEAPs) established in India and Pakistan consisting of people with psychosis and their caregivers to inform research, engagement and capacity-building procedures of the project; a total of 8 meetings held to date (5 in India; 3 in Pakistan). 
  • Theory of Change conducted with people with psychosis, caregivers and care providers to inform the development of community engagement for psychosis in Pakistan. 
  • Theatre of the Oppressed workshops in India (3) and Pakistan (3) to inform the research and development of independent TO companies.  
  • 55 TO forum play performances held to initiate dialogue on psychosis and SMI in schools, communities and facilities across India and Pakistan. 
  • Established the Small-Scale Research Grants initiative to build local evidence generation and build capacity for research in India and Pakistan.

References

  1. Lora A, Kohn R, Levav I, McBain R, Morris J, Saxena S. Service availability and utilization and treatment gap for schizophrenic disorders: a survey in 50 low- and middle-income countries. Bull World Health Organ. (2012) 90:47–54. 10.2471/BLT.11.089284 
  2. Asher L, Fekadu A, Hanlon C. Global mental health and schizophrenia. Curr Opin Psychiatry. (2018) 31:193–9. 10.1097/YCO.0000000000000404 
  3. Singh OP. Closing treatment gap of mental disorders in India: opportunity in new competency-based medical council of India curriculum. Indian J Psychiatry. (2018) 60:375–6. 10.4103/psychiatry.IndianJPsychiatry_458_18 
  4. Nawaz R, Gul S, Amin R, Huma T, Al Mughairbi F. Overview of schizophrenia research and treatment in Pakistan. Heliyon. 2020 Nov 1;6(11):e05545. 
  5. Asher L, Patel V, De Silva MJ. Community-based psychosocial interventions for people with schizophrenia in low and middle-income countries: systematic review and meta-analysis. BMC Psychiatry. (2017) 17:355. 10.1186/s12888-017-1516-7 
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