Clinical trial NCT04282915: Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)
Official title: Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Depressive Disorder
Anxiety Disorder
Alcohol Use Disorder
Psychotic Disorders
Keywords: Primary care
Stigma
Developing countries
Mental health
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Transcultural Psychosocial Organization Nepal
name: King's College London
First posted: 2020-02-25
Enrollment: 1300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized controlled trial with municipalities being the unit of randomization. 24 municipalities will be randomized to either RESHAPE or implementation as usual. Three health facilities in each municipality will participate in the study. All primary care providers with prescribing rights will be trained based on their municipality randomization arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A growing number of trials have demonstrated treatment effectiveness for mental illness by non-specialist providers, such as primary care providers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against people with mental illness. Therefore, interventions are needed to address attitudes among non- specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE), is an intervention for non-specialists in which social contact with persons with mental illness is added to training and supervision programs. A cluster randomized control trial will address primary objectives including changes in stigma (Social Distance Scale) and improved quality of mental health services, operationalized as accuracy of identifying patients with mental illness in primary care. The control condition is existing mental health training and supervision for non-specialists delivered through the Nepal Ministry of Health's adaptation of the World Health Organization mental health Gap Action Programme. The intervention condition will incorporate social contact with people with mental illness into existing training and supervision. Participants in the cluster randomized control trial will be the direct beneficiaries of training and supervision (primary care providers) and indirect beneficiaries (their patients). Primary care workers' outcomes include stigma (Social Distance Scale), knowledge (mental health Gap Action Programme knowledge scale), implicit attitudes (Implicit Association Test), clinical self-efficacy (mental health Gap Action Programme knowledge scale), and clinical competence (Enhancing Assessment of Common Therapeutic factors) to be assessed pre-training, post-training, and at 3- and 6-month follow-up. Accuracy of diagnoses will be determined through the Structured Clinical Interview for the Diagnostic and Statistical Manual version 5, which will be assessed at 3 months after patient enrollment. Patient outcomes include functioning, quality of life, psychiatric symptoms, medication side effects, barriers to care, and cost of care assessed at enrollment and 3 and 6 months. This study will inform decisions regarding inclusion of persons living with mental illness in training primary care providers.

Detailed description: 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.

Eligibility criteria: \*\*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

Primary outcomes:
measure: Social Distance Scale (SDS)
timeFrame: 6 months post training
measure: Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5)
timeFrame: 3-months post-patient enrollment
Secondary outcomes:
measure: mental health Gap Action Programme knowledge test
timeFrame: 6 months post-training
measure: mental health Gap Action Programme knowledge test
timeFrame: 3 months post-training
measure: mental health Gap Action Programme knowledge test
timeFrame: immediately after the training
measure: mental health Gap Action Programme self-efficacy assessment
timeFrame: 6-months post-training
measure: mental health Gap Action Programme self-efficacy assessment
timeFrame: 3-months post-training
measure: mental health Gap Action Programme self-efficacy assessment
timeFrame: immediately after the training
measure: Implicit Association Test
timeFrame: 6-months post-training
measure: Implicit Association Test
timeFrame: 3-months post-training
measure: Implicit Association Test
timeFrame: immediately after the training
measure: Enhancing Assessment of Common Therapeutic factors
timeFrame: 6 months post-training
measure: Enhancing Assessment of Common Therapeutic factors
timeFrame: 3 months post-training
measure: Enhancing Assessment of Common Therapeutic factors
timeFrame: immediately after the training
measure: Social Distance Scale
timeFrame: 3 months post training
measure: Social Distance Scale
timeFrame: immediately after the training
measure: Patient: World Health Organization Disability Assessment Scale
timeFrame: 6-months post enrollment
measure: Patient: World Health Organization Disability Assessment Scale
timeFrame: 3-months post enrollment
measure: Patient Health Questionnaire 9
timeFrame: 6-months post enrollment
measure: Patient Health Questionnaire 9
timeFrame: 3-months post enrollment
measure: Patient: Generalized Anxiety Disorder 7
timeFrame: 6 months post enrollment
measure: Patient: Generalized Anxiety Disorder 7
timeFrame: 3 months post enrollment
measure: Patient: Positive and Negative Symptoms of Schizophrenia
timeFrame: 6 months post enrollment
measure: Patient: Positive and Negative Symptoms of Schizophrenia
timeFrame: 3 months post enrollment
measure: Patient: Alcohol Use Disorder Identification Test
timeFrame: 6-months post enrollment
measure: Patient: Alcohol Use Disorder Identification Test
timeFrame: 3-months post enrollment
measure: Patient: Euroqol 5 dimension 5 level
timeFrame: 6-months post enrollment
measure: Patient: Euroqol 5 dimension 5 level
timeFrame: 3-months post enrollment
measure: Patient: Cost of Service Receipt Inventory
timeFrame: 6-months post-enrollment
measure: Patient: Cost of Service Receipt Inventory
timeFrame: 3-months post-enrollment
measure: Patient: Enhancing Assessment of Common Therapeutic factors
timeFrame: 6-months post-enrollment
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Transcultural Psychosocial Organization Nepal
state: Gandaki
Study officials:
affiliation: George Washington University
name: Brandon A Kohrt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohrt BA, Turner EL, Gurung D, Wang X, Neupane M, Luitel NP, Kartha MR, Poudyal A, Singh R, Rai S, Baral PP, McCutchan S, Gronholm PC, Hanlon C, Lempp H, Lund C, Thornicroft G, Gautam K, Jordans MJD. Implementation strategy in collaboration with people with lived experience of mental illness to reduce stigma among primary care providers in Nepal (RESHAPE): protocol for a type 3 hybrid implementation effectiveness cluster randomized controlled trial. Implement Sci. 2022 Jun 16;17(1):39. doi: 10.1186/s13012-022-01202-x.