Implementing Suicide Prevention Into Primary Care in Nepal

Yale University

Status: Enrolling

Conditions: Primary Care; Suicide

Treatments: Behavioral: Suicide Prevention Package (PSuPP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07362056

2000036105

5R34MH135122 (U.S. NIH Grant/Contract)

1R34MH135122-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Suicide remains a major contributor to global mortality, with particularly high and persistent rates in low-resourced settings such as South Asia. In Nepal, ongoing integration of mental health services into primary care provides a critical opportunity to strengthen suicide risk assessment and management. Despite the scale-up of mhGAP training for primary care providers (PCPs), gaps remain in the systematic detection, referral, and follow-up of individuals at risk for suicide. There is an urgent need to enhance mhGAP implementation with strategies that address provider workload, stigma, and inequities within the health workforce.

Using experience-based co-design principles and RE-AIM this study will assess the feasibility and acceptability of integrating an implementation strategy package to optimize mhGAP suicide prevention delivery in Nepal's decentralized primary healthcare system. This clinical trial leverages deep collaboration with a community advisory board of individuals with lived experience of suicide throughout the trials' design, delivery and analysis.

This R34 will generate critical preliminary evidence on the feasibility, acceptability, and implementation of an integrated suicide prevention package within government primary care facilities in Nepal. The findings will inform the design and parameters of a future fully powered effectiveness trial, while aligning with Nepal's national suicide prevention strategy and advancing WHO and NIMH global mental health priorities.

Enrollment: 147 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Primary Care Providers

• Health workers with a prescribing license employed in government health facilities in Bagmati Province.
• Are between 21-65 years, per government health system criteria.
• Participants will be required to have competency in Nepali, be actively engaged in care provision within their health facility

Patients:

• Patient lives in the study site
• Is under the care of a PCP at a facility site.
• Patient meets any level of suicide risk based on mhGAP 2.0 criteria.
• Patients who have been treated for mental illness before or presently (expected in both groups).
• Speaks Nepali.
• Levels of Suicide Risk (as defined by mhGAP 2.0)

Exclusion criteria

Primary Care Providers

• Healthcare workers without proper government credentials will be excluded.
• Health workers who plan to migrate or who do not intend to stay in the study area for at least a year.

Patients:

• Patient requiring immediate hospitalization
• Unable to consent as determined by the diminished capacity tool.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 2 patient groups

Treatment As Usual

No Intervention group

Description:

PCPs will receive standard or refresher mhGAP training. The training follows Nepal's district mental health plan for primary care workers with prescribing credentials. Paramedical staff are included because most primary healthcare facilities lack doctors, making them the primary frontline primary care providers. The training is based on the WHO mhGAP Intervention Guide and focuses on five priority conditions in Nepal: depression, psychosis, epilepsy, alcohol use disorder, and suicide. Training is delivered over 5 days by a Nepali psychiatrist with government issued credentials to facilitate mhGap training and subsequent ongoing supervision. After training, PCPs receive psychiatric supervision approximately every three months as per the Nepal government mhGap protocol. Patient participants in the TAU arm will receive the services based on mhGAP treatment protocols.

TAU+Suicide Prevention Package (PSuPP)

Experimental group

Description:

PCPs will receive all components of TAU. In addition, they receive an implementation package to optimize mhGAP siucide prevention delivery. The implementation package includes: \[assessment optimization\] systematic assessment training using systematized screening questions, an embedded decision-support tool, \[risk management optimization\] culturally adapted safety planning, and \[follow up care optimization\] a collaborative care protocol with Community Health Workers (CHWs) to support patient follow-up uptake and continued care. Participants in the PSuPP arm will receive all TAU services with aforementioned implementation strategies.

Treatment:

Behavioral: Suicide Prevention Package (PSuPP)