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Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT) (RESHAPE-cRCT)

Primary Purpose

Mental Disorder, Depressive Disorder, Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Reducing Stigma among Healthcare Providers (RESHAPE)
mental health Gap Action Programme
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorder focused on measuring Primary care, Stigma, Developing countries, Mental health

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

**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

Sites / Locations

  • Transcultural Psychosocial Organization NepalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Implementation as Usual

RESHAPE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
Enhancing Assessment of Common Therapeutic factors
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Enhancing Assessment of Common Therapeutic factors
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Enhancing Assessment of Common Therapeutic factors
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Patient: World Health Organization Disability Assessment Scale
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Patient: World Health Organization Disability Assessment Scale
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Patient Health Questionnaire 9
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Patient Health Questionnaire 9
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Patient: Generalized Anxiety Disorder 7
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Patient: Generalized Anxiety Disorder 7
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Patient: Positive and Negative Symptoms of Schizophrenia
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Patient: Positive and Negative Symptoms of Schizophrenia
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Patient: Alcohol Use Disorder Identification Test
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Patient: Alcohol Use Disorder Identification Test
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Patient: Euroqol 5 dimension 5 level
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Patient: Euroqol 5 dimension 5 level
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Patient: Barriers in Access to Care Evaluation
Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse
Patient: Barriers in Access to Care Evaluation
Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse
Patient: Cost of Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total costs
Patient: Cost of Service Receipt Inventory
Costs of care to patients, , there is no maximum or minimum score, the outcome is total costs
Patient: Enhancing Assessment of Common Therapeutic factors
Common factors use by primary care provider, minimum score = 0, maximum = 15, higher score is better

Full Information

First Posted
February 19, 2020
Last Updated
June 2, 2023
Sponsor
George Washington University
Collaborators
Duke University, Transcultural Psychosocial Organization Nepal, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04282915
Brief Title
Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)
Acronym
RESHAPE-cRCT
Official Title
Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
Duke University, Transcultural Psychosocial Organization Nepal, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Depressive Disorder, Anxiety Disorder, Alcohol Use Disorder, Psychotic Disorders
Keywords
Primary care, Stigma, Developing countries, Mental health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
There are two types of study participants: primary care providers and primary care patients. Based on the municipality of randomization, primary care providers will either participate in RESHAPE training or implementation as usual training. Patients will not be randomized because the health facilities they attend are already assigned to either having the primary care providers trained through RESHAPE or implementation as usual. The providers and patients will be masked to the implementation, i.e., they will not be given information on the differences in the two different implementation strategies. Research assistants and research psychiatrists who conduct the assessments will be masked to whether the provider or patients are in the RESHAPE or implementation-as-usual arms.
Allocation
Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implementation as Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RESHAPE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reducing Stigma among Healthcare Providers (RESHAPE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
mental health Gap Action Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Distance Scale (SDS)
Description
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time Frame
6 months post training
Title
Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5)
Description
Accuracy of clinical diagnosis (this a diagnostic tool, there are no maximum or minimum scores)
Time Frame
3-months post-patient enrollment
Secondary Outcome Measure Information:
Title
mental health Gap Action Programme knowledge test
Description
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Time Frame
6 months post-training
Title
mental health Gap Action Programme knowledge test
Description
Multiple-choice assessment from mental health Gap Action Programme training materials, minimum = 0, maximum = 100, higher is better outcome
Time Frame
3 months post-training
Title
mental health Gap Action Programme knowledge test
Description
Multiple-choice assessment from mental health Gap Action Programme training materials, minimum = 0, maximum = 100, higher is better outcome
Time Frame
immediately after the training
Title
mental health Gap Action Programme self-efficacy assessment
Description
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
Time Frame
6-months post-training
Title
mental health Gap Action Programme self-efficacy assessment
Description
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
Time Frame
3-months post-training
Title
mental health Gap Action Programme self-efficacy assessment
Description
Self-reported clinical efficacy for mental health services, minimum = 0; maximum = 5, higher score is better outcome
Time Frame
immediately after the training
Title
Implicit Association Test
Description
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
Time Frame
6-months post-training
Title
Implicit Association Test
Description
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
Time Frame
3-months post-training
Title
Implicit Association Test
Description
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
Time Frame
immediately after the training
Title
Enhancing Assessment of Common Therapeutic factors
Description
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Time Frame
6 months post-training
Title
Enhancing Assessment of Common Therapeutic factors
Description
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Time Frame
3 months post-training
Title
Enhancing Assessment of Common Therapeutic factors
Description
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Time Frame
immediately after the training
Title
Social Distance Scale
Description
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time Frame
3 months post training
Title
Social Distance Scale
Description
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time Frame
immediately after the training
Title
Patient: World Health Organization Disability Assessment Scale
Description
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Time Frame
6-months post enrollment
Title
Patient: World Health Organization Disability Assessment Scale
Description
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Time Frame
3-months post enrollment
Title
Patient Health Questionnaire 9
Description
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Time Frame
6-months post enrollment
Title
Patient Health Questionnaire 9
Description
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Time Frame
3-months post enrollment
Title
Patient: Generalized Anxiety Disorder 7
Description
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Time Frame
6 months post enrollment
Title
Patient: Generalized Anxiety Disorder 7
Description
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Time Frame
3 months post enrollment
Title
Patient: Positive and Negative Symptoms of Schizophrenia
Description
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Time Frame
6 months post enrollment
Title
Patient: Positive and Negative Symptoms of Schizophrenia
Description
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Time Frame
3 months post enrollment
Title
Patient: Alcohol Use Disorder Identification Test
Description
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Time Frame
6-months post enrollment
Title
Patient: Alcohol Use Disorder Identification Test
Description
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Time Frame
3-months post enrollment
Title
Patient: Euroqol 5 dimension 5 level
Description
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Time Frame
6-months post enrollment
Title
Patient: Euroqol 5 dimension 5 level
Description
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Time Frame
3-months post enrollment
Title
Patient: Barriers in Access to Care Evaluation
Description
Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse
Time Frame
6-months post-enrollment
Title
Patient: Barriers in Access to Care Evaluation
Description
Barriers to accessing mental health care, minimum = 0, maximum = 108, higher score is worse
Time Frame
3-months post-enrollment
Title
Patient: Cost of Service Receipt Inventory
Description
Costs of care to patients, there is no maximum or minimum score, the outcome is total costs
Time Frame
6-months post-enrollment
Title
Patient: Cost of Service Receipt Inventory
Description
Costs of care to patients, , there is no maximum or minimum score, the outcome is total costs
Time Frame
3-months post-enrollment
Title
Patient: Enhancing Assessment of Common Therapeutic factors
Description
Common factors use by primary care provider, minimum score = 0, maximum = 15, higher score is better
Time Frame
6-months post-enrollment
Other Pre-specified Outcome Measures:
Title
Abnormal involuntary movement scale
Description
Abnormal movements associated with antipsychotic medication, minimum score = 0, maximum score = 40, higher score is worse
Time Frame
3-months post-treatment initiation
Title
Antidepressant side-effect checklist
Description
Side effects of antidepressant medication, minimum score = 0, maximum score = 63, higher score is worse
Time Frame
3-months post-treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Kohrt, MD, PhD
Phone
2027412896
Email
bkohrt@gwu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon A Kohrt, MD, PhD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transcultural Psychosocial Organization Nepal
City
Pokhara
State/Province
Province 4
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dristy Gurung, MSc
Phone
+977 1-4424082
Email
dristy.1.gurung@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information will be shared through National Institute of Mental Health Data Archives
IPD Sharing Time Frame
Data will become available after publication of the primary and secondary outcomes manuscripts
IPD Sharing Access Criteria
Managed through the National Institute of Mental Health Data Archives
Citations:
PubMed Identifier
35710491
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.
Results Reference
derived

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Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)

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