Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)

Conditions
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Anxiety Disorder, Mental Disorder, Depressive Disorder, Alcohol Use Disorder, Psychotic Disorders

Intervention / Treatment
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* Other: Reducing Stigma among Healthcare Providers (RESHAPE)
* Other: mental health Gap Action Programme


Participation Criteria
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Eligibility Criteria
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**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 21 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Implementation as Usual<br>Primary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme adapted by the Nepal Ministry of Health. | Other: mental health Gap Action Programme<br>* The mental health Gap Action Programme is a training program for primary care providers in mental health services. The curriculum has been developed by the World Health Organization and was adapted in Nepal and certified by the Ministry of Health.<br>|
| Experimental: RESHAPE<br>Primary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme, plus they will have co-facilitation by mental health service users providing recovery testimonials as well as aspirational figures presenting testimonies and conducting myth-busting sessions. | Other: Reducing Stigma among Healthcare Providers (RESHAPE)<br>* Mental health service users are trained using Photo Voice to develop recovery story testimonials. They then participate in primary care providers mental health Gap Action Programme training. In addition, aspirational figures are trained to provider testimonials and conduct myth-busting.<br>Other: mental health Gap Action Programme<br>* The mental health Gap Action Programme is a training program for primary care providers in mental health services. The curriculum has been developed by the World Health Organization and was adapted in Nepal and certified by the Ministry of Health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Distance Scale (SDS) | 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | 6 months post training | 
| Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5) | Accuracy of clinical diagnosis (this a diagnostic tool, there are no maximum or minimum scores) | 3-months post-patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mental health Gap Action Programme knowledge test | Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome | 6 months post-training | 
| mental health Gap Action Programme knowledge test | Multiple-choice assessment from mental health Gap Action Programme training materials, minimum = 0, maximum = 100, higher is better outcome | 3 months post-training | 
| mental health Gap Action Programme knowledge test | Multiple-choice assessment from mental health Gap Action Programme training materials, minimum = 0, maximum = 100, higher is better outcome | immediately after the training | 
| mental health Gap Action Programme self-efficacy assessment | Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome | 6-months post-training | 
| mental health Gap Action Programme self-efficacy assessment | Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome | 3-months post-training | 
| mental health Gap Action Programme self-efficacy assessment | Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome | immediately after the training | 
| Implicit Association Test | Computer-based neuropsychological assessment of implicit bias related to mental illness, there is no maximum or minimum score, score is D-score based on comparison of timing; positive scores equal more bias | 6-months post-training | 
| Implicit Association Test | Computer-based neuropsychological assessment of implicit bias related to mental illness, there is no maximum or minimum score, score is D-score based on comparison of timing; positive scores equal more bias | 3-months post-training | 
| Implicit Association Test | Computer-based neuropsychological assessment of implicit bias related to mental illness, there is no maximum or minimum score, score is D-score based on comparison of timing; positive scores equal more bias | immediately after the training | 
| Enhancing Assessment of Common Therapeutic factors | Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better | 6 months post-training | 
| Enhancing Assessment of Common Therapeutic factors | Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better | 3 months post-training | 
| Enhancing Assessment of Common Therapeutic factors | Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better | immediately after the training | 
| Social Distance Scale | 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | 3 months post training | 
| Social Distance Scale | 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome | immediately after the training | 
| Patient: World Health Organization Disability Assessment Scale | Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse | 6-months post enrollment | 
| Patient: World Health Organization Disability Assessment Scale | Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse | 3-months post enrollment | 
| Patient Health Questionnaire 9 | Depression symptoms, minimum = 0, maximum = 27, higher score is worse | 6-months post enrollment | 
| Patient Health Questionnaire 9 | Depression symptoms, minimum = 0, maximum = 27, higher score is worse | 3-months post enrollment | 
| Patient: Generalized Anxiety Disorder 7 | Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse | 6 months post enrollment | 
| Patient: Generalized Anxiety Disorder 7 | Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse | 3 months post enrollment | 
| Patient: Positive and Negative Symptoms of Schizophrenia | Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse | 6 months post enrollment | 
| Patient: Positive and Negative Symptoms of Schizophrenia | Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse | 3 months post enrollment | 
| Patient: Alcohol Use Disorder Identification Test | Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse | 6-months post enrollment | 
| Patient: Alcohol Use Disorder Identification Test | Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse | 3-months post enrollment | 
| Patient: Euroqol 5 dimension 5 level | Quality of life symptoms, minimum = 5, maximum=25, higher score is worse | 6-months post enrollment | 
| Patient: Euroqol 5 dimension 5 level | Quality of life symptoms, minimum = 5, maximum=25, higher score is worse | 3-months post enrollment | 
| Patient: Barriers in Access to Care Evaluation | Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse | 6-months post-enrollment | 
| Patient: Barriers in Access to Care Evaluation | Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse | 3-months post-enrollment | 
| Patient: Cost of Service Receipt Inventory | Costs of care to patients, there is no maximum or minimum score, the outcome is total costs | 6-months post-enrollment | 
| Patient: Cost of Service Receipt Inventory | Costs of care to patients, , there is no maximum or minimum score, the outcome is total costs | 3-months post-enrollment | 
| Patient: Enhancing Assessment of Common Therapeutic factors | Common factors use by primary care provider, minimum score = 0, maximum = 15, higher score is better | 6-months post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary care, Stigma, Developing countries, Mental health