- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282915
Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT) (RESHAPE-cRCT)
Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brandon Kohrt, MD, PhD
- Phone Number: 2027412896
- Email: bkohrt@gwu.edu
Study Locations
-
-
Province 4
-
Pokhara, Province 4, Nepal
- Recruiting
- Transcultural Psychosocial Organization Nepal
-
Contact:
- Dristy Gurung, MSc
- Phone Number: +977 1-4424082
- Email: dristy.1.gurung@kcl.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
**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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Implementation as Usual
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.
|
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.
|
Experimental: RESHAPE
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Distance Scale (SDS)
Time Frame: 6 months post training
|
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
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6 months post training
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Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5)
Time Frame: 3-months post-patient enrollment
|
Accuracy of clinical decision making (this a diagnostic tool, there are no maximum or minimum scores, the objective is to determine if an appropriate diagnosis is selected that will lead to appropriate management)
|
3-months post-patient enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mental health Gap Action Programme knowledge test
Time Frame: 6 months post-training
|
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
Time Frame: 3 months post-training
|
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
Time Frame: immediately after the training
|
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
Time Frame: 6-months post-training
|
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
Time Frame: 3-months post-training
|
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
Time Frame: immediately after the training
|
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
|
immediately after the training
|
Implicit Association Test
Time Frame: 6-months post-training
|
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
Time Frame: 3-months post-training
|
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
Time Frame: immediately after the training
|
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
Time Frame: 6 months post-training
|
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
Time Frame: 3 months post-training
|
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
Time Frame: immediately after the training
|
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
Time Frame: 3 months post training
|
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
Time Frame: immediately after the training
|
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
Time Frame: 6-months post enrollment
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Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
|
6-months post enrollment
|
Patient: World Health Organization Disability Assessment Scale
Time Frame: 3-months post enrollment
|
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
|
3-months post enrollment
|
Patient Health Questionnaire 9
Time Frame: 6-months post enrollment
|
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
|
6-months post enrollment
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Patient Health Questionnaire 9
Time Frame: 3-months post enrollment
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Depression symptoms, minimum = 0, maximum = 27, higher score is worse
|
3-months post enrollment
|
Patient: Generalized Anxiety Disorder 7
Time Frame: 6 months post enrollment
|
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
|
6 months post enrollment
|
Patient: Generalized Anxiety Disorder 7
Time Frame: 3 months post enrollment
|
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
|
3 months post enrollment
|
Patient: Positive and Negative Symptoms of Schizophrenia
Time Frame: 6 months post enrollment
|
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
|
6 months post enrollment
|
Patient: Positive and Negative Symptoms of Schizophrenia
Time Frame: 3 months post enrollment
|
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
|
3 months post enrollment
|
Patient: Alcohol Use Disorder Identification Test
Time Frame: 6-months post enrollment
|
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
|
6-months post enrollment
|
Patient: Alcohol Use Disorder Identification Test
Time Frame: 3-months post enrollment
|
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
|
3-months post enrollment
|
Patient: Euroqol 5 dimension 5 level
Time Frame: 6-months post enrollment
|
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
|
6-months post enrollment
|
Patient: Euroqol 5 dimension 5 level
Time Frame: 3-months post enrollment
|
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
|
3-months post enrollment
|
Patient: Cost of Service Receipt Inventory
Time Frame: 6-months post-enrollment
|
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
Time Frame: 3-months post-enrollment
|
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
Time Frame: 6-months post-enrollment
|
Common factors use by primary care provider, minimum score = 0, maximum = 15, higher score is better
|
6-months post-enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abnormal involuntary movement scale
Time Frame: 3-months post-treatment initiation
|
Abnormal movements associated with antipsychotic medication, minimum score = 0, maximum score = 40, higher score is worse
|
3-months post-treatment initiation
|
Antidepressant side-effect checklist
Time Frame: 3-months post-treatment initiation
|
Side effects of antidepressant medication, minimum score = 0, maximum score = 63, higher score is worse
|
3-months post-treatment initiation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brandon A Kohrt, MD, PhD, George Washington University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH120649 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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