To evaluate the clinical effectiveness and cost-effectiveness of a Community-Based Intervention for improving symptoms and social functioning in people with schizophrenia

Schizophrenia is a severe mental disorder that usually has an onset in early adulthood, and is often associated with chronic persistent or relapsing symptoms. People with schizophrenia experience thought disturbances such as delusions or hallucinations, and disturbances in speech, behaviour or emotions.

Most people with schizophrenia in developing countries such as India receive facility based treatment i.e. medical care in outpatient and inpatient mental health institutions. However such care is expensive causing a severe strain on health resources of these countries and on patients and their families, who bear heavy out-of-pocket costs. Moreover, there is only one psychiatrist for every 3000-5000 persons with schizophrenia, showing that a large proportion of people receive little or no treatment.

There is now a growing consensus that treatment for this disorder should be in community settings, combining medical and psycho-social interventions for the best outcomes. Firstly, there is strong evidence to suggest that even high quality outpatient care alone does not lead to good outcomes for many people with schizophrenia in developing countries. Secondly, community care, as the term implies, is more accessible for many people with schizophrenia who cannot avail the continuity of care provided by institutions. Finally, providing community-based interventions may go beyond reducing symptoms to also improve overall quality of life and may also reduce stigma and promote human rights for people who frequently experience rights abuses in institutional settings.

Community based interventions need to be provided in addition to existing care, and need to be relatively low cost and simple to implement if they are to be scaled up. Based on these principles, COPSI evolved as a project that sought to provide a set of community based interventions (known as Collaborative Community Based Care or CCBC), in addition to Facility Based Care (FBC). These interventions are delivered by who are known as “Community Health Workers??? (CHW), persons with no qualifications or experience in the field, drawn from the local community and rigorously trained by experts to deliver this care. The training is based on an intervention manual that follows a modular structure covering various aspects of illness, specific components of the intervention and the operational requirements of the trial related to documentation and supervision. They are supervised by the treating psychiatrists, who will ensure that CHW provide the right need based care to supplement medical treatments. This makes the intervention potentially acceptable, affordable and sustainable in the long term.

The COPSI project is divided into three phases: the first in which the intervention is developed, the second in which researchers evaluate the intervention in a randomised controlled trial, and the final one in which the results of the trial are analysed and disseminated.

Having started in 2008, the team first developed and refined an intervention, and then developed a manual to help guide community health workers in delivering the treatment. Training was conducted on different aspects of the disorder and delivery of the intervention by experts in the field. Handouts and flip charts were given to them and the team worked at each of the facilities in the project setting.

The second phase involved recruiting a total of 282 subjects over 11 months across three sites; with 92 in Goa. The trial was carried out in three settings: Goa, Satara and rural Tamil Nadu.

Overall across all sites, 38 per cent of all persons with schizophrenia who were screened were approached for assent; the two most common reasons for not considering the others for potential inclusion were that subjects did not meet the ‘overall moderate severity’ criteria or that they resided outside the designated catchment area of the study. Of the subjects who met all inclusion criteria, most (94 per cent) assented for the consent interview. A total of 332 potential participants and their caregivers were taken through a contextually appropriate and innovative consent procedure using the traditional information sheet and a specially designed consent flip chart.

Seventy-four per cent of participants and caregivers approached for consent to participate agreed to be part of the trial: all persons who consented to participate completed baseline assessments and were randomised as planned (2:1 allocation to the CCBC: FBC arms).

The manual helped ensure that community health workers delivered the treatments according to expected standards, and supervision including group meetings with intervention coordinator assured fidelity and quality. There were no major variations deviations from the protocol for delivering the intervention across the three sites. Overall, the acceptability of the intervention was adequate with minimal (five per cent) dropout which was very encouraging.

Currently, the team is involved in data analysis, dissemination and putting together the first round of papers for publication. Once all the results of the trial are available, the team will widely disseminate the findings among various stakeholders. A COPSI resource kit has been developed comprising the COPSI training manual for the community health workers, intervention flip chart, 14 intervention handouts, recovery stories booklet and videos about people with schizophrenia and their families telling their stories of illness and recovery in a deeply personal way.

To access the videos, please click here to watch the video based in Tamil Nadu and here to watch the video based in Maharashtra.

Implications of the project
The team hopes to provide evidence that the large treatment gap for people with severe mental disorders and the critical lack of human resources can be bridged using low-cost community resources. Through this, the study is expected to have a significant impact on policy and advocacy efforts nationally and with global health organisations.

To view the intervention manual draft click here