Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)

There continues to be a major gap between the global burden of persons with mental illness and the number of patients receiving adequate treatment. In the U.S. and other high-income countries, approximately 1 out of 5 persons receives minimally adequate care. In lower-middle income countries, it ranges from 1 out of 27 to 1 out of 100 persons. To address this gap in low- and middle-income countries, a key strategy has been the use of primary care health workers to detect and deliver of care for mental illness. The World Health Organization has developed the mental health Gap Action Programme to train primary care workers to detect mental illness and deliver evidence-supported treatment. However, research to date suggests that implementation strategies for mental health Gap Action Programme are inadequate as evidenced by low detection rates. In Nepal, fewer than half of persons with mental illness were correctly identified by mental health Gap Action Programme-trained primary care workers. A potential barrier to effective implementation of primary care detection is stigma among primary care workers against persons with mental illness.

Our preliminary work suggests that reducing primary care workers' stigma against persons with mental illness may improve accurate detection of mental illness. A version of the mental health Gap Action Programme training that includes a stigma reduction component was developed: REducing Stigma among HealthcAre ProvidErs (RESHAPE). In RESHAPE, persons with mental illness (i.e., service users) are trained to share recovery stories, conduct myth-busting sessions, and promote mental health advocacy. A pilot cluster randomized controlled trial was conducted in Nepal comparing standard mental health Gap Action Programme training delivered psychiatrists and psychosocial specialists with a mental health Gap Action Programme training delivered by both specialists and service users (RESHAPE). Consistent with high-income country literature demonstrating that interaction with service users reduces stigma more effectively that only providing knowledge, stigma was lower among the RESHAPE- arm trained health workers. The pilot results also suggest that reducing stigma may improve detection of mental illness. Therefore, involvement of mental health service users in training primary care workers may reduce stigma, and that stigma reduction may mediate improved detection of mental illness. If these findings are confirmed in an appropriately powered cluster randomized controlled trial, this service user collaborative implementation strategy could make a major contribution to improving primary care detection in low- and middle-income countries, as well as in the U.S. A hybrid implementation-effectiveness (type-3) cluster randomized controlled trial will be in Nepal comparing mental health Gap Action Programme standard implementation with the RESHAPE implementation strategy. Our team of U.S. and Nepali researchers, in partnership with the Nepal Ministry of Health, demonstrated the feasibility of the cluster randomized controlled trial design and identified strategies for cost effectiveness modeling. Target conditions will be depressive disorder, psychotic disorders, and alcohol use disorder.

Aim 1 - To evaluate the impact of the RESHAPE service user engagement on stigma among primary care workers. Hypothesis: Primary care workers in the RESHAPE arm will have less stigma toward persons with mental illness (measured with the Social Distance Scale) 3 months after training compared with primary care workers in the standard training.

Aim 2 - To evaluate the impact of the RESHAPE training on accuracy (sensitivity and specificity) of detection, as measured by the proportion of true positive and true negative diagnoses among patients presenting to primary care facilities, as confirmed by a psychiatrist's structured clinical interview; and to evaluate stigma as a mediator of differences in accuracy. Hypothesis: Primary care workers in the RESHAPE arm will have greater accuracy of detecting mental illness. Secondary analyses: implementation arm differences in patient quality adjusted life years and cost utility will be evaluated.

**Primary Care Providers**

Inclusion criteria

• All health workers from the facilities included in the study will be invited to participate
• Health workers will be between 18 and 65 years of age based on employment criteria
• within the government health system.
• All participants will need to have Nepali language competency,
• be actively engaged in care provision in their health cluster,
• have a valid certificate of practice from the Ministry of Health
• Health workers will need to have permission from their health supervisor to attend the entire duration of the training,

Exclusion criteria

• any prior citations on their clinical practice licensure or any other government credentialing violations.

**Patients**

Inclusion criteria

• All patients (with non-emergency medical needs) presenting to the primary care
• any of the following groups:
• (a) any mental illness diagnosis including depression, psychosis (bipolar disorder with a manic episode, schizophrenia, major depressive disorder with psychotic features, and alcohol use disorder with psychosis) and alcohol use disorder; plus the other conditions included in Nepal's mental health Gap Action Programme: anxiety, conversion, epilepsy, dementia, child and adolescent, other substance abuse (these patients are included because misdiagnosis is common with regard to missing or overdiagnosing one condition in place of another mental illness); comorbid conditions are also acceptable;
• (b) any patients screening above cut-off scores on the tools; and
• (c) 10% of patients who are negative on all of the above criteria.
• any patients previously treated for mental illness would be included
• age range will be 16 years or older, with no upper age limit (mental health Gap Action Programme training covers child and adolescent through mental illnesses affecting elderly population).
• all participants will be able to speak Nepali
• able to complete the research interview with the research assistants who will read all of the assessment tools.

Exclusion criteria

• Patients with immediate medical needs requiring referral and emergency services (e.g., serious injury; pre-eclampsia; dehydration; status epilepticus)
• patients needing acute psychiatric services (e.g., suicide attempts, alcohol withdrawal, psychosis/mania that cannot be managed in a community setting) who are referred for immediate hospitalization
• Patients under the age of 16 years old will be excluded