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Suicide PreventionNCT06094959

Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts

A study testing Suicide Prevention Package in people with Suicide Prevention, run by Yale University at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to assess the feasibility and acceptability of implementing a co-designed suicide prevention package of implementation strategies (SuPP) in a pilot open, non-randomized, clinical trial. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Suicide Prevention
What is being tested?
Suicide Prevention Package
How many people
37 participants
Where
1 siteNepal
Study dates
30 May 2023to 23 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be older than 18 at the time of recruitment
  • Speak Nepali fluently
  • Be actively employed by Dhulikhel Hospital/KUSMS
  • Have a valid certificate of practice from the Ministry of Health and Population
  • Speak Nepali fluently
  • Be older than 18 at the time of recruitment
Show all 10Show fewer
  • Be actively receiving care from a KUDH clinician
  • Permanently reside in Dhulikhel District
  • Have access to a cell phone
  • Screen positive for suicide risk

Who cannot join

  • Have less than 3 months of experience in current position
  • Be planning to remain in the study area or current position for less than six months
  • Be unable to provide voluntary informed consent for any reason
  • Reside outside of the catchment area
  • Be planning to leave relocate their residence in the next 6 months
  • Unable to provide voluntary informed consent for any reason
  • Unable to provide a mobile phone number for contact
  • Present evidence of active and untreated mania or psychosis that could interfere with the participant's ability to volitionally consent to research or interfere with their ability to safely and reliably complete research

Trial locations and contacts

1 site in 1 country.

Nepal1 site
  • Dhulikhel Hospital

    Dhulikhel

Other trials in Nepal

About this study

The goal of this study is to assess the feasibility and acceptability of implementing a co-designed suicide prevention package of implementation strategies (SuPP) in a pilot open, non-randomized, clinical trial. The main questions it aims to answer are:

  1. What is the feasibility of implementing the SuPP open clinical trial?
  2. What is the degree to which SuPP was implemented correctly
  3. What is the perceived acceptability of SuPP among providers and patients?

Participants will include healthcare providers and patients at risk for suicide. Providers will identify and provide culturally adapted safety planning and contact follow up to at-risk patients over a period of six months. Patients will receive an initial culturally adapted patient-centered safety plan and receive a tapered series of contacts (phone calls) over the course of six months from health providers.

Read the detailed description

Low and middle income countries (LMIC) hold 75% of the world's suicides. Suicide disproportionately affects those living in poverty and in adverse conditions and, in LMIC settings, up to 20% of maternal deaths are due to suicide. In Nepal, suicide is a leading cause of death among women of reproductive age. Despite the disproportionate burden, systematic suicide detection and prevention mechanisms are nearly non-existent. Deaths are only a fraction of the burden, where evidence from Nepal reports between 5 and 27% of individuals have current thoughts of suicide. Suicidal behavior remains under-reported and is difficult for clinicians to properly identify and monitor, especially in limited health systems. This calls for improved understanding of how to identify and monitor individuals at risk for suicidal behavior. Therefore, this study seeks to integrate existing hospital healthcare providers into suicide prevention, contributing much needed evidence for multi-pronged, accessible strategies to reduce a leading cause of death worldwide.

This study's purpose is to adapt and pilot the implementation of packaged suicide prevention strategies in a low-resource setting. The impact involves informing an implementation plan to test in a fully powered future trial. Findings will contribute to the evidence of systems-integrated suicide prevention strategies and result in a multi-level package for mental health service integration that can be utilized around the world. Ultimately, this project will save lives and improve under-resourced health systems. The pilot trial is not powered for statistical analysis, but data will be monitored monthly and continuously analyzed to facilitate iterative revision, then finalization of the protocol.

The implementation package to be tested (the Suicide Prevention Package, SuPP) will include a culturally adapted suicide crisis response plan and a series of contacts via phone call from a hospital healthcare provider. This is a small open, non-randomized, pilot trial to assess the feasibility and acceptability of SuPP within the existing health system. The investigators will select delivery agents, an implementation strategy, and complete SuPP training. The investigators will train the selected delivery agents and their supervisory team (e.g., hospital nurses, physicians, and department heads) in SuPP (detection, safety planning, brief contact follow up). Participants will be recruited through the hospital's emergency department. Following suicide risk detection (e.g., suicide attempt in the past 6 months), 24 at-risk patients will be enrolled in the open trial and given the full SuPP package. All participants will receive standard of care, the SuPP package is in addition. In accordance with recommendations for pilot trial studies, The investigators have established qualitative and quantitative indicators to guide decisions about what procedures to carry through to the full trial and when modifications should be made. Each patient will be provided contact and suicide crisis response planning (weekly, then tapering to monthly) for at least 6 months. SuPP feasibility and acceptability will be determined by the following criteria: delivery agent fidelity to SuPP elements at 75% or greater; retention of at least 70% of participants through 6 months of SuPP; fewer than 15% missing items on outcome measures across all assessments; 80% of delivery agents and patients finding SuPP acceptable. In domains where criteria are met, the investigators will retain the procedure for a future full trial. In domains where criteria are not met, the investigators will modify procedures for the future full trial.

Being tested
Suicide Prevention Package
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suicide Prevention PackageOther

    The implementation package consists of co-designed and culturally adapted suicide prevention elements including suicide crisis response planning, contact follow up phone calls, and healthcare provider support mechanisms to optimize implementation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility assessed by recruitment

    Recruitment defined as the percent of eligible participants that agree to participate

    Measured: 6 months post intervention

  2. Feasibility assessed by treatment adherence

    The percent of participants that completed one session with the intervention delivery agent

    Measured: 6 months post intervention

  3. Feasibility assessed by treatment adherence- SuPP

    Treatment adherence defined as the percent of participants who remain in SuPP

    Measured: 6 months post intervention

  4. Feasibility assessed by retention

    The percent of participants who completed all follow up measures

    Measured: 6 months post intervention

  5. Feasibility assessed by retention- missing items

    The percent of missing measure items per participant

    Measured: 6 months post intervention

  6. Feasibility assessed by screening

    The number of participants screened and referred

    Measured: 6 months post intervention

  7. Percent enrolled

    The percent of referred participants that enrolled

    Measured: 6 months post intervention

  8. Median number of sessions completed

    Median number of sessions completed

    Measured: 6 months post intervention

Secondary outcomes (1)
  1. Acceptability assessed by Consolidated Framework for Implementation Research (CFIR) qualitative interviews

    CFIR interviews are qualitative interviews that will be thematically analyzed with qualitative analysis guided by the CFIR framework and taxonomy.

    Measured: 6 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start30 May 2023
  3. Primary completion8 Jul 2024
  4. Study completion23 Jul 2024

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094959
Sponsor's protocol ID
2000029480
Other IDs
No NIH funding
Status last verified
Oct 2024
First submitted
13 Oct 2023
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shrestha AP, Shrestha R, Risal A, Shakya R, Sigdel K, Bajracharya R, Paudel P, Gumudavelly D, Egger E, Zhuang S, Vijayakumar L, Hagaman A. Evaluating implementation preparedness for suicide screening and referral in a Nepali emergency department: A mixed-methods study. Implement Res Pract. 2025 Jul 6;6:26334895251343644. doi: 10.1177/26334895251343644. eCollection 2025 Jan-Dec.

    PubMed 40630920

Questions about this trial

What is this clinical trial studying?

A study testing Suicide Prevention Package in people with Suicide Prevention, 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 29 Oct 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility assessed by recruitment (time frame: 6 months post intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06094959, which also lists 1 linked publication.

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 29 Oct 2024.

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