Implementing Suicide Prevention Into Primary Care in Nepal

Официальное название

Integrating a Suicide Prevention Package of Strategies Into Decentralized Primary Health Care Systems: an Implementation Pilot Study in Rural Nepal

Обзор

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.

Вмешательства

• Поведенческое Suicide Prevention Package (PSuPP)
  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.

Первичные конечные точки

• Percent intervention arm uptake to assess feasibility [Срок оценки: 6 months]
• Percentage of interviews that hold themes [Срок оценки: 6 months]
• Percent retention to assess feasibility [Срок оценки: 6 months]
• Structured checklist to assess fidelity [Срок оценки: 6 months]
• Percent successful allocation procedures [Срок оценки: 6 months]
• Percent adherence to the randomization protocol [Срок оценки: 6 months]
• Percent deviations to the randomization protocol [Срок оценки: 6 months]
• Percent participants who completed all follow up measures [Срок оценки: 6 months]
• Percent missing measure items per participant [Срок оценки: 6 months]
• Mean Beck Scale for Suicide Ideation (BSSI) score [Срок оценки: Baseline; 3 months; 6 months]

Вторичные конечные точки (11)

• Suicide Prevention Knowledge survey [Срок оценки: Baseline, 3 months; 6 months]
• Mean Self-Efficacy in Mental Health Care survey score [Срок оценки: Baseline; 3 month; 6 month]
• Mean Clinical Competency and Communication Skills (ENACT) score [Срок оценки: Baseline; 6 months]
• Columbia Suicide Severity Rating Scale [Срок оценки: Baseline; 3 months; 6 months]
• Mean Patient Health Questionnaire (PHQ-9) score [Срок оценки: Baseline; 3 months; 6 months]
• Mean Suicide Cognitions Scale (SCS) score [Срок оценки: Baseline; 3 months; 6 months]
• Suicide-Related Coping Scale (SRCS) - Internal Coping Skills [Срок оценки: Baseline; 3 months; 6 months]
• Suicide-Related Coping Scale (SRCS) - External Coping Skills [Срок оценки: Baseline; 3 months; 6 months]
• Mean Generalized Anxiety Disorder (GAD-7) score [Срок оценки: Baseline; 3 months; 6 months]
• Mean Social Connectedness Scale score [Срок оценки: Baseline; 3 months; 6 months]
• Client Service Receipt Inventory to assess health service uptake [Срок оценки: Baseline; 3 months; 6 months]

Критерии участия

Критерии включения

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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Nepal · 1 центр

• Primary care facilities — Dolakhā

Идентификаторы

NCT: NCT07362056 · 2000036105 · 5R34MH135122 · 1R34MH135122-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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