SuicideNCT07362056
Implementing Suicide Prevention Into Primary Care in Nepal
A study testing Suicide Prevention Package (PSuPP) in people with Suicide and Primary Care, run by Yale University at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Primary Care
- What is being tested?
- Suicide Prevention Package (PSuPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteNepal
- Study dates
- 15 Nov 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integrating a Suicide Prevention Package of Strategies Into Decentralized Primary Health Care Systems: an Implementation Pilot Study in Rural Nepal
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
- Suicide, Primary Care
- Being tested
- Suicide Prevention Package (PSuPP)
- Keywords
- suicide prevention, primary care, implementation science, Nepal
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Prevention Package (PSuPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Suicide Prevention Package (PSuPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Percent successful allocation procedures
Percent successful allocation procedures followed
Measured: 6 months
Percent adherence to the randomization protocol
Percent adherence to the randomization protocol
Measured: 6 months
Percent deviations to the randomization protocol
Percent deviations to the randomization protocol
Measured: 6 months
Percent participants who completed all follow up measures
Percent participants who completed all follow up measures
Measured: 6 months
Percent missing measure items per participant
Percent missing measure items per participant
Measured: 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.
Measured: Baseline; 3 months; 6 months
Secondary outcomes (11)
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.
Measured: Baseline, 3 months; 6 months
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.
Measured: Baseline; 3 month; 6 month
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.
Measured: Baseline; 6 months
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.
Measured: Baseline; 3 months; 6 months
Mean Patient Health Questionnaire (PHQ-9) score
Depression measured with PHQ-9. PHQ-9 is a 9-item validated questionnaire. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The item scores are summed with total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline; 3 months; 6 months
Mean Suicide Cognitions Scale (SCS) score
The SCS includes 21 items that assess suicide-related cognitions, including negative expectations about the future, maladaptive self-perceptions, and emotional pain. The scale asks respondents to rate the extent to which they agree with experience specific suicide-related thoughts and beliefs. Responses are recorded on a Likert-type scale ranging from 1 to 5 from strongly disagree to strongly agree, and item scores are summed to produce a total score (21-105), with higher scores indicating greater severity of suicide-related cognitive distress. Assessed in patients only.
Measured: Baseline; 3 months; 6 months
Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
Assess suicide-related internal coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better internal coping). Assessed in patients only.
Measured: Baseline; 3 months; 6 months
Suicide-Related Coping Scale (SRCS) - External Coping Skills
Assess suicide-related internal coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better external coping). Assessed in patients only.
Measured: Baseline; 3 months; 6 months
Mean Generalized Anxiety Disorder (GAD-7) score
Anxiety measured with GAD-7, a 7 item self report instrument that measures anxiety Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. Assessed in patients only.
Measured: Baseline; 3 months; 6 months
Mean Social Connectedness Scale score
The Social Connectedness Scale consists of 8 items that assess perceived sense of closeness, belonging, and connection with others. The scale consists of multiple items that ask respondents to rate their agreement on a scale of 1 to 5, with 1 indicating strong disagreement and 5 indicating strong agreement. Higher scores indicate higher social connection. Assessed in patients only.
Measured: Baseline; 3 months; 6 months
Client Service Receipt Inventory to assess health service uptake
Percent services utilized will be assessed using the Client Services Receipt Inventory which measures use of health and social care services ranging from community delivered care from community health workers, to primary care services, to specialist services, and traditional health services. Assessed in patients only.
Measured: Baseline; 3 months; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Nov 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Possible
- Responsible party
- Sponsor
- Investigators
- Ashley K Hagaman, PhD, MPH, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362056
- Sponsor's protocol ID
- 2000036105
- Other IDs
- 5R34MH135122, 1R34MH135122-01
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified data will be shared through NIH designated data repositories consistent with data sharing under the NIH GDS policy. Clinical data of those research participants who will provide consent for sharing their data will be be included.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Suicide Prevention Package of Strategies Into Decentralized Primary Health Care Systems: an Implementation Pilot Study in Rural Nepal
- ClinicalTrials.gov ID
- NCT07362056
- Acronym / sponsor ID
- 2000036105
- Conditions
- Suicide, Primary Care
- Keywords
- suicide prevention, primary care, implementation science, Nepal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Possible
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Suicide Prevention Package (PSuPP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Patient lives in the study site
Key exclusion criteria (6 listed)
- 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.
- Patient requiring immediate hospitalization
- Unable to consent as determined by the diminished capacity tool.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TAU+Suicide Prevention Package (PSuPP) |
Primary outcome
Percent intervention arm uptake to assess feasibility
Time frame: 6 months
Percent primary care providers (PCPs) that attend the implementation training. Feasibility will be defined as 70% or more uptake.
Percentage of interviews that hold themes
Time frame: 6 months
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.
Percent retention to assess feasibility
Time frame: 6 months
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.
Structured checklist to assess fidelity
Time frame: 6 months
18-item structured checklist assessed in a standardized behavioral rehearsal to assess fidelity to the mhGAP suicide module protocol
Percent successful allocation procedures
Time frame: 6 months
Percent successful allocation procedures followed
Percent adherence to the randomization protocol
Time frame: 6 months
Percent adherence to the randomization protocol
Percent deviations to the randomization protocol
Time frame: 6 months
Percent deviations to the randomization protocol
Percent participants who completed all follow up measures
Time frame: 6 months
Percent participants who completed all follow up measures
Percent missing measure items per participant
Time frame: 6 months
Percent missing measure items per participant
Mean Beck Scale for Suicide Ideation (BSSI) score
Time frame: Baseline; 3 months; 6 months
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.
11 secondary outcomes
Suicide Prevention Knowledge survey
Time frame: Baseline, 3 months; 6 months
Mean Self-Efficacy in Mental Health Care survey score
Time frame: Baseline; 3 month; 6 month
Mean Clinical Competency and Communication Skills (ENACT) score
Time frame: Baseline; 6 months
Columbia Suicide Severity Rating Scale
Time frame: Baseline; 3 months; 6 months
Mean Patient Health Questionnaire (PHQ-9) score
Time frame: Baseline; 3 months; 6 months
Mean Suicide Cognitions Scale (SCS) score
Time frame: Baseline; 3 months; 6 months
Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
Time frame: Baseline; 3 months; 6 months
Suicide-Related Coping Scale (SRCS) - External Coping Skills
Time frame: Baseline; 3 months; 6 months
Mean Generalized Anxiety Disorder (GAD-7) score
Time frame: Baseline; 3 months; 6 months
Mean Social Connectedness Scale score
Time frame: Baseline; 3 months; 6 months
Client Service Receipt Inventory to assess health service uptake
Time frame: Baseline; 3 months; 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Only de-identified data will be shared through NIH designated data repositories consistent with data sharing under the NIH GDS policy. Clinical data of those research participants who will provide consent for sharing their data will be be included.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley K Hagaman, PhD, MPH principal investigator
Yale School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide Prevention Package (PSuPP) in people with Suicide and Primary Care, run by Yale University at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley K Hagaman, PhD, MPH (2487908954, ashley.hagaman@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent intervention arm uptake to assess feasibility (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.