Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)

NCT04282915 | Completed DMC

• 1 other identifier: R01MH120649
• Study Type: interventional
• Target: 8,705
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder; Depressive Disorder; Anxiety Disorder; Alcohol Use Disorder; Psychotic Disorders

Keywords

Primary care; Stigma; Developing countries; Mental health

Outcome Measures

Primary Outcomes (2)

• Social Distance Scale (SDS)

  12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome

  6 months post training

• Structured Clinical Interview for Diagnostic and Statistical Manual 5 (SCID-5)

  Accuracy of clinical 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 Outcomes (29)

• mental health Gap Action Programme knowledge test

  6 months post-training

• mental health Gap Action Programme knowledge test

  3 months post-training

• mental health Gap Action Programme knowledge test

  immediately after the training

• mental health Gap Action Programme self-efficacy assessment

  6-months post-training

• mental health Gap Action Programme self-efficacy assessment

  3-months post-training

Study Arms (2)

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.

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.

Other: Reducing Stigma among Healthcare Providers (RESHAPE); Other: mental health Gap Action Programme

Interventions

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.

RESHAPE

mental health Gap Action Programme OTHER

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.

Implementation as Usual; RESHAPE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• any prior citations on their clinical practice licensure or any other government credentialing violations.
• \*\*Patients\*\*
• 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.
• 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

Sponsors & Collaborators

• George Washington University: lead
• Duke University: collaborator
• Transcultural Psychosocial Organization Nepal: collaborator
• King's College London: collaborator

Study Sites (1)

Transcultural Psychosocial Organization Nepal

Pokhara, Gandaki, Nepal

Location

Related Publications (1)

• 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.

  PMID: 35710491 DERIVED

MeSH Terms

Conditions

Mental Disorders; Depressive Disorder; Anxiety Disorders; Alcoholism; Psychotic Disorders; Social Stigma; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mood Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Social Behavior; Behavior; Personal Satisfaction

Study Officials

• Brandon A Kohrt, MD, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: February 22, 2022
• Primary Completion: January 15, 2025
• Study Completion: March 3, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available after publication of the primary and secondary outcomes manuscripts
• Access Criteria: Managed through the National Institute of Mental Health Data Archives

Locations

NE (1)