Suicide Prevention Clinical Trial
Official title:
Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | October 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria (healthcare workers): - 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 Exclusion Criteria (healthcare workers) - 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 Inclusion Criteria (trial patients): - Speak Nepali fluently - Be older than 18 at the time of recruitment - Be actively receiving care from a KUDH clinician - Permanently reside in Dhulikhel District - Have access to a cell phone - Screen positive for suicide risk Exclusion Criteria (trial patients): - 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 |
Country | Name | City | State |
---|---|---|---|
Nepal | Dhulikhel Hospital | Dhulikhel |
Lead Sponsor | Collaborator |
---|---|
Yale University | American Foundation for Suicide Prevention, Dhulikhel Hospital, Kathmandu University School of Medical Sciences |
Nepal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility assessed by recruitment | Recruitment defined as the percent of eligible participants that agree to participate | 6 months post intervention | |
Primary | Feasibility assessed by treatment adherence | The percent of participants that completed one session with the intervention delivery agent | 6 months post intervention | |
Primary | Feasibility assessed by treatment adherence- SuPP | Treatment adherence defined as the percent of participants who remain in SuPP | 6 months post intervention | |
Primary | Feasibility assessed by retention | The percent of participants who completed all follow up measures | 6 months post intervention | |
Primary | Feasibility assessed by retention- missing items | The percent of missing measure items per participant | 6 months post intervention | |
Primary | Feasibility assessed by screening | The number of participants screened and referred | 6 months post intervention | |
Primary | Percent enrolled | The percent of referred participants that enrolled | 6 months post intervention | |
Primary | Median number of sessions completed | Median number of sessions completed | 6 months post intervention | |
Secondary | 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. | 6 months post intervention |
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