Implementing Suicide Prevention Into Primary Care in Nepal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Patient lives in the study site
Disqualifiers
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.
Patient requiring immediate hospitalization
Unable to consent as determined by the diminished capacity tool.
Trial design
Design model
Parallel
Treatments tested in this trial
Suicide Prevention Package (PSuPP)
BehavioralImplementation 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.
Treatment groups
147 Participants
are divided into 2 treatment groupsGroup A: Treatment As UsualNo intervention 0 interventions
Group B: TAU+Suicide Prevention Package (PSuPP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 months4
Structured checklist to assess fidelity
18-item structured checklist assessed in a standardized behavioral rehearsal to assess fidelity to the mhGAP suicide module protocol
Time frame
6 monthsSecondary outcomes
1
Suicide Prevention Knowledge survey
The mhGAP knowledge survey includes 9 items related to suicide specific knowledge related to suicide risk presentation, management, and carer engagement aligned with the mhGAP suicide prevention protocol. Total score range XXXXX. Higher scores indicate more knowledge. Assessed in PCPs only.
Time frame
Baseline, 3 months; 6 months2
Mean Self-Efficacy in Mental Health Care survey score
The mhGAP Self Efficacy is a self-administered measure assessing healthcare providers' confidence in assessing, diagnosing, and managing mental health conditions. Our adapted tool has 45 items across all domains and 8 items that focus specifically on suicide. Respondents select a range of responses between 1 and 5 with 1 feeling totally unable to do the domain and 5 feeling totally able to do the domain. Higher scores indicate higher self-efficacy. Assessed in PCPs only.
Time frame
Baseline; 3 month; 6 month3
Mean Clinical Competency and Communication Skills (ENACT) score
This is an observed role play with a trained rater to assess competence and interpersonal skills in delivering mental health interventions. The tool evaluates core competencies in psychological care delivery including: Communication, Emotional Engagement, Assessment, Social Relations, Planning and Process. communication skills, empathy, active listening, and patient engagement. Total score range 0-3. Higher scores indicate higher competence. Assessed in PCPs only.
Time frame
Baseline; 6 months4
Columbia Suicide Severity Rating Scale
The CSSRS asks about self-reported suicide attempt, aborted attempt, preparatory behavior, and interrupted attempt with "yes" or "no" questions branching format. Any positive responses to these behaviors will be coded as 'yes'. Behaviors are assessed at baseline as the past 3 months and lifetime and subsequent assessments have a window of the past three months. Participants will be categorized as low, medium or high risk based on their answers to specific questions. Assessed in patients only.
Time frame
Baseline; 3 months; 6 monthsSponsors and contacts
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Yale University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Possible
Collaborator
Source ClinicalTrials.gov