Supervised Treatment in Out-Patients for Schizophrenia (STOPS+)

Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms including hallucinations (hearing or seeing things that don't exist), delusions (unusual beliefs not based on reality), muddled thoughts based on hallucinations or delusions and changes in behaviour. Schizophrenia is a common cause of long-term disability in the 15-49-year-old group and whilst effective treatments are available, in developing countries around two thirds of patients receive no treatment.

This lack of treatment, commonly known as the 'treatment gap' arises due to factors including poor treatment adherence, a lack of primary care involvement and poor access treatments. We have previously reported a new approach (Supervised Treatment in Out-Patients for Schizophrenia (STOPS)) that resulted in improved treatment adherence and functioning in a resource poor setting in Khyber Pakhtunkhwa (KP), Pakistan. In this study we trained and supported relatives and family members to monitor medication taking, building on the success of a similar approach used for patients with tuberculosis.

We now aim to implement and evaluate a 'scaled-up' version of STOPS (STOPS+) which is based on the World Health Organisation mental health guidelines and maintain treatment adherence with the help of family members and text message reminders. We will work with primary care physicians and multipurpose primary are technicians to task shift care, under the supervision of mental health experts.

The study has 3 phases:
PHASE 1: PRE-IMPLEMENTATION PHASE involving community engagement, modification of STOP to STOPS+ (involving patient, healthcare and wider community partners) and the identification of potential study participants.

PHASE 2: IMPLEMENTATION OF STOPS+ IN PRIMARY CARE SETTINGS USING A CLUSTER TRIAL DESIGN to determine the clinical and cost-effectiveness. 24 primary care centres in district Peshawar, KP will be randomised to deliver either STOPS+ or Enhanced Treatment As Usual (ETAU). We will recruit 526 patients (263 in each arm) suffering from Schizophrenia or schizoaffective disorder based on the International Classification of Diseases (ICD)-10 criteria. The outcomes of interest will include Global Assessment of Functioning and adherence to treatment regimen.

PHASE 3: EVALUATION OF THE IMPLEMENTATION IN REAL WORLD SETTING will be measured using the standardised World Health Organization's Assessment Instrument for Mental Health Systems (WHO-AIMS), economic evaluation, secondary data from the trial and utilisation of primary health care, and in depth interview study involving all participants.

If successful this trial will improve schizophrenia care, improving lives for patients and their families. This work will provide important information for policy makers and set the foundations for reducing disability and improving long term patient outcomes.

In developing countries but about two third of patients suffering from schizophrenia receive no treatment. This lack of treatment, commonly known as treatment gap arises mainly due to poor treatment adherence, lack of primary care involvement and poor access to the treatment. We previously reported an intervention called Supervised Treatment in Out-Patients for Schizophrenia (STOPS) that led to significantly improved treatment adherence.

We now aim to implement and evaluate scaled up version of STOPS, called STOPS+ ; which will consist of following components: treatment for schizophrenia based on WHO mhGAP guidelines, maintaining treatment adherence with the help of a trained family member for dispensing and administering medication, monitoring the availability of essential psychotropic medication and task shifting to PHC Physician and Multipurpose PHC Technician (MT) for treatment and monitoring. The research plan includes three phases.

1. PRE-IMPLEMENTATION PHASE involving community engagement and a qualitative study

2. IMPLEMENTATION OF STOPS+ IN PRIMARY CARE SETTINGS USING A CLUSTER RCT DESIGN

24 PHC centres in district Peshawar, KP will be randomised to STOPS+ or Enhanced Treatment As Usual (ETAU). We will recruit 526 patients (263 in each arm) suffering from Schizophrenia or schizoaffective disorder based on the International Classification of Diseases (ICD)-10 criteria. The outcomes will be: (i) primary clinical outcome-Global Assessment of Functioning (GAF) (ii) primary process outcome - adherence to treatment regimen.

3. EVALUATION OF THE IMPLEMENTATION IN REAL WORLD SETTING will be done using the standardised World Health Organization's Assessment Instrument for Mental Health Systems (WHO-AIMS), economic evaluation, secondary data from the trial and utilisation of PHC, and in depth interview with study participants.

PATHWAYS TO IMPACT:
The following will be the pathways to impact:

1. The evidence from this project will influence the public health policy on mental health. The mental health is rarely part of public health policy in many developing countries. This is due to lack of reliable evidence on which policy can be based, especially for the public health interventions. The study will provide the real world data for scaling up the services for severe mental illness. This will not create the regionally as well as in other LMIC countries. Therefore, the implementation of STOPS+ will have direct national and ultimately international impact.

2. The research project will reduce the stigma by providing effective treatment in the community. This will help the patients with severe mental illness to integrate better in the community, which will impact the perception of mental illness in the community and will help to promote the mental health well-being.

3. Better monitoring of health parameters, especially those related to side effects of commonly used antipsychotics which are likely to cause significant weight gain, will result in better physical health care for those suffering from severe mental illness. This will impact the physical health outcomes and in improving the physical morbidly in this population.

4. Close working with primary care and implementation procedures to monitor the physical and mental health of patients in the primary care will have considerable ripple effects on multiple parameters in the community. This will include reduction in restraints for people with schizophrenia due to effective treatment, less substance abuse and reduced burden of disease for family members. These parameters will create impact in the family and community life, such as reduced domestic violence, improved schooling for the children living in affected families and reduced poverty.