NCT04282915Completed
Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)
Reducing Stigma Among Healthcare Providers to Improve Mental Health Services: Cluster Randomized Controlled Trial (RESHAPE-cRCT)
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8705 (actual)
- First submitted
- 19 Feb 2020
- Start date
- 22 Feb 2022
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- George Washington University
- NCT number
- NCT04282915
What you commit to
- Study type: Interventional
- Participants enrolled: 8705
- From 22 Feb 2022 to the primary completion date, 15 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- any prior citations on their clinical practice licensure or any other government credentialing violations.
- \*\*Patients\*\*
Other illness
- 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
Age
- Patients under the age of 16 years old will be excluded
Other
- Patients with immediate medical needs requiring referral and emergency services (e.g., serious injury; pre-eclampsia; dehydration; status epilepticus)
Who the study is looking for
- All health workers from the facilities included in the study will be invited to participate
- Health workers will be between 18 and 65 years of age based on employment criteria
- within the government health system.
- All participants will need to have Nepali language competency,
- be actively engaged in care provision in their health cluster,
- have a valid certificate of practice from the Ministry of Health
- Health workers will need to have permission from their health supervisor to attend the entire duration of the training,
- 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.
Criteria the registry did not label
- \*\*Primary Care Providers\*\*
Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Transcultural Psychosocial Organization Nepal Coordinator of this site? Confirm its status | Pokhara | Nepal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.