Implementing Suicide Prevention Into Primary Care in Nepal

NCT07362056 | Recruiting

• 3 other identifiers: 20000361055R34MH1351221R34MH135122-01
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Care; Suicide

Keywords

suicide prevention; primary care; implementation science; Nepal

Outcome Measures

Primary Outcomes (10)

• Percent intervention arm uptake to assess feasibility

  Percent primary care providers (PCPs) that attend the implementation training. Feasibility will be defined as 70% or more uptake.

  6 months

• Percentage of interviews that hold themes

  Qualitative feasibility acceptability data will be deemed acceptable if it demonstrates provider and patient perceptions of P-SuPP benefits to clinical care and mhGAP implementation and the absence of themes that suggest -SuPP is disruptive, unlikeable, and unacceptable. Acceptability will be assessed as the percentage of interviews that hold themes suggesting SuPP is disruptive, unlikeable, and unacceptable.

  6 months

• Percent retention to assess feasibility

  Percent participants enrolled (PCPs and Patients) who complete the study of all enrolled. Feasibility is established as retention of at least 65% completion of 6 month follow up of patients and PCPs.

  6 months

• Structured checklist to assess fidelity

  18-item structured checklist assessed in a standardized behavioral rehearsal to assess fidelity to the mhGAP suicide module protocol

  6 months

• Percent successful allocation procedures

  Percent successful allocation procedures followed

  6 months

• Percent adherence to the randomization protocol

  Percent adherence to the randomization protocol

  6 months

• Percent deviations to the randomization protocol

  Percent deviations to the randomization protocol

  6 months

• Percent participants who completed all follow up measures

  Percent participants who completed all follow up measures

  6 months

• Percent missing measure items per participant

  Percent missing measure items per participant

  6 months

• Mean Beck Scale for Suicide Ideation (BSSI) score

  Suicide ideation severity measured with BSSI. BSSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during the past week. The first 19 items consist of three options graded are on a 3-point scale ranging from 0 to 2. These items are then summed to yield a total score, which ranges from 0 to 36. Higher scores indicate higher severity of suicide ideation. Assessed in patients only.

  Baseline; 3 months; 6 months

Secondary Outcomes (11)

• Suicide Prevention Knowledge survey

  Baseline, 3 months; 6 months

• Mean Self-Efficacy in Mental Health Care survey score

  Baseline; 3 month; 6 month

• Mean Clinical Competency and Communication Skills (ENACT) score

  Baseline; 6 months

• Columbia Suicide Severity Rating Scale

  Baseline; 3 months; 6 months

• Mean Patient Health Questionnaire (PHQ-9) score

  Baseline; 3 months; 6 months

Study Arms (2)

Treatment As Usual

NO INTERVENTION

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

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.

Behavioral: Suicide Prevention Package (PSuPP)

Interventions

Suicide Prevention Package (PSuPP) BEHAVIORAL

Implementation package to optimize mhGAP siucide prevention delivery which 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 CHWs to support patient follow-up uptake and continued care.

TAU+Suicide Prevention Package (PSuPP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator
• Possible: collaborator

Study Sites (1)

Primary care facilities

Dolakhā, Nepal

RECRUITING

MeSH Terms

Conditions

Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Ashley K Hagaman, PhD, MPH

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley K Hagaman, PhD, MPH

CONTACT

2487908954; ashley.hagaman@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 23, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

NE (1)