Mental DisorderRESHAPE-cRCTNCT04282915
Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)
A study testing Reducing Stigma among Healthcare Providers (RESHAPE) and mental health Gap Action Programme in people with Mental Disorder and Depressive Disorder, run by George Washington University at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Depressive Disorder, Anxiety Disorder
- What is being tested?
- Reducing Stigma among Healthcare Providers (RESHAPE) and mental health Gap Action Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,705 participants
- Where
- 1 siteNepal
- Study dates
- 22 Feb 2022to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- Health workers will need to have permission from their health supervisor to attend the entire duration of the training,
- 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.
Who cannot join
- any prior citations on their clinical practice licensure or any other government credentialing violations.
- Patients
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)
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.
Read the 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.
- Conditions
- Mental Disorder, Depressive Disorder, Anxiety Disorder, Alcohol Use Disorder, Psychotic Disorders
- Being tested
- Reducing Stigma among Healthcare Providers (RESHAPE), mental health Gap Action Programme
- Keywords
- Primary care, Stigma, Developing countries, Mental health
- Medical subject headings
- Mental Disorders, Depressive Disorder, Anxiety Disorders, Alcoholism, Psychotic Disorders, Social Stigma, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Stigma among Healthcare Providers (RESHAPE)Other
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.
mental health Gap Action ProgrammeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation as Usual | Active comparator | 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. Receives: Other: mental health Gap Action Programme |
| RESHAPE | Experimental | 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. Receives: Other: Reducing Stigma among Healthcare Providers (RESHAPE); Other: mental health Gap Action Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post training
Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5)
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)
Measured: 3-months post-patient enrollment
Secondary outcomes (29)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately after the training
Patient: World Health Organization Disability Assessment Scale
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Measured: 6-months post enrollment
Patient: World Health Organization Disability Assessment Scale
Assessment of daily functioning, minimum = 12, maximum = 60; higher score is worse
Measured: 3-months post enrollment
Patient Health Questionnaire 9
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Measured: 6-months post enrollment
Patient Health Questionnaire 9
Depression symptoms, minimum = 0, maximum = 27, higher score is worse
Measured: 3-months post enrollment
Patient: Generalized Anxiety Disorder 7
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Measured: 6 months post enrollment
Patient: Generalized Anxiety Disorder 7
Anxiety symptoms, minimum = 0, maximum = 21, higher score is worse
Measured: 3 months post enrollment
Patient: Positive and Negative Symptoms of Schizophrenia
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Measured: 6 months post enrollment
Patient: Positive and Negative Symptoms of Schizophrenia
Psychosis symptoms, minimum = 0, maximum = 56, higher score is worse
Measured: 3 months post enrollment
Patient: Alcohol Use Disorder Identification Test
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Measured: 6-months post enrollment
Patient: Alcohol Use Disorder Identification Test
Alcohol Use Disorder symptoms, minimum = 0, maximum = 40, higher score is worse
Measured: 3-months post enrollment
Patient: Euroqol 5 dimension 5 level
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Measured: 6-months post enrollment
Patient: Euroqol 5 dimension 5 level
Quality of life symptoms, minimum = 5, maximum=25, higher score is worse
Measured: 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
Measured: 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
Measured: 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
Measured: 6-months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start22 Feb 2022
- Primary completion15 Jan 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Transcultural Psychosocial Organization Nepal, King's College London
- Responsible party
- Principal investigator, Brandon A Kohrt, MD, PhD, George Washington University
- Investigators
- Brandon A Kohrt, MD, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282915
- Sponsor's protocol ID
- R01MH120649
- Acronym
- RESHAPE-cRCT
- Status last verified
- Jun 2025
- First submitted
- 19 Feb 2020
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be shared through National Institute of Mental Health Data Archives
Publications
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.
PubMed 35710491
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)
- ClinicalTrials.gov ID
- NCT04282915
- Acronym / sponsor ID
- RESHAPE-cRCT / R01MH120649
- Conditions
- Mental Disorder, Depressive Disorder, Anxiety Disorder, Alcohol Use Disorder, Psychotic Disorders
- Keywords
- Primary care, Stigma, Developing countries, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,705 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Duke University, Transcultural Psychosocial Organization Nepal, King's College London
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation as Usual | Active comparator | Other: mental health Gap Action ProgrammePrimary care providers will be trained in the 7-day curriculum of the mental health Gap Action Programme adapted by the Nepal Ministry of Health. |
| RESHAPE | Experimental | Other: Reducing Stigma among Healthcare Providers (RESHAPE), Other: mental health Gap Action ProgrammePrimary 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (5 listed)
- any prior citations on their clinical practice licensure or any other government credentialing violations.
- Patients
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducing Stigma among Healthcare Providers (RESHAPE)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. | Other | RESHAPE |
| mental health Gap Action ProgrammeThe 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. | Other | Implementation as Usual, RESHAPE |
Primary outcome
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
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)
29 secondary outcomes
mental health Gap Action Programme knowledge test
Time frame: 6 months post-training
mental health Gap Action Programme knowledge test
Time frame: 3 months post-training
mental health Gap Action Programme knowledge test
Time frame: immediately after the training
mental health Gap Action Programme self-efficacy assessment
Time frame: 6-months post-training
mental health Gap Action Programme self-efficacy assessment
Time frame: 3-months post-training
mental health Gap Action Programme self-efficacy assessment
Time frame: immediately after the training
Implicit Association Test
Time frame: 6-months post-training
Implicit Association Test
Time frame: 3-months post-training
Implicit Association Test
Time frame: immediately after the training
Enhancing Assessment of Common Therapeutic factors
Time frame: 6 months post-training
Enhancing Assessment of Common Therapeutic factors
Time frame: 3 months post-training
Enhancing Assessment of Common Therapeutic factors
Time frame: immediately after the training
Social Distance Scale
Time frame: 3 months post training
Social Distance Scale
Time frame: immediately after the training
Patient: World Health Organization Disability Assessment Scale
Time frame: 6-months post enrollment
Patient: World Health Organization Disability Assessment Scale
Time frame: 3-months post enrollment
Patient Health Questionnaire 9
Time frame: 6-months post enrollment
Patient Health Questionnaire 9
Time frame: 3-months post enrollment
Patient: Generalized Anxiety Disorder 7
Time frame: 6 months post enrollment
Patient: Generalized Anxiety Disorder 7
Time frame: 3 months post enrollment
Patient: Positive and Negative Symptoms of Schizophrenia
Time frame: 6 months post enrollment
Patient: Positive and Negative Symptoms of Schizophrenia
Time frame: 3 months post enrollment
Patient: Alcohol Use Disorder Identification Test
Time frame: 6-months post enrollment
Patient: Alcohol Use Disorder Identification Test
Time frame: 3-months post enrollment
Patient: Euroqol 5 dimension 5 level
Time frame: 6-months post enrollment
Patient: Euroqol 5 dimension 5 level
Time frame: 3-months post enrollment
Patient: Cost of Service Receipt Inventory
Time frame: 6-months post-enrollment
Patient: Cost of Service Receipt Inventory
Time frame: 3-months post-enrollment
Patient: Enhancing Assessment of Common Therapeutic factors
Time frame: 6-months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 35710491Kohrt 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.
- Individual participant dataSharing planned: Yes. Information will be shared through National Institute of Mental Health Data Archives
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon A Kohrt, MD, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Stigma among Healthcare Providers (RESHAPE) and mental health Gap Action Programme in people with Mental Disorder and Depressive Disorder, run by George Washington University at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Distance Scale (SDS) (time frame: 6 months post training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.