Treating Drivers of Suicide Using Jaspr Health

Alcohol Use Disorder Clinical Trial

Official title: Treating Drivers of Suicide in Primary Care Using Jaspr Health

Status Not yet recruiting

Clinical Trial Summary

The goal of this Fast-Track Small Business Innovation Research (SBIR) project is to test the newly expanded Jaspr2.0, developed to efficiently and reliably aid delivery of recommended best-practices for the treatment of suicidal ideation in adults, including suicidal individuals who also misuse alcohol. Jaspr1.0 was developed by the PIs under NIMH SBIR Phase I and Phase II awards (R43MH108222 & R44MH108222; Dimeff & Jobes). This current proposal will expand Jaspr content to include content relevant to primary care and brief interventions for the treatment of suicidal ideation and alcohol misuse. Jaspr2.0 will include techniques for prevention of suicidal behaviors (ideation, planning, attempts) and death by suicide while providing support in the moment after discharge via a companion mobile app, Jaspr-at-Home. Jaspr2.0 will include: psychoeducation, behavioral skills training, crisis stabilization planning, lethal means management, brief interventions for the treatment of suicidal ideation and alcohol misuse, and messages of hope, wisdom, and insights from people with lived experience (PLE).

Investigators will conduct a 12-week randomized controlled clinical trial (N=120) comparing Jaspr2.0 (n=60) to an active control condition (Virtual Hope Box + electronic wellness resources brochure; n=60) in adults experiencing suicidal ideation. Participants will be randomly assigned to condition utilizing a minimization randomization procedure to match participants across condition on suicide severity, depression severity, and alcohol misuse. To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% (n=42) of the sample will be comprised of individuals who experience harmful or hazardous levels of alcohol use. Participants will be assessed at baseline, 4, 8, and 12 weeks. Investigators will conduct a small 6-week pilot trial (N=20; Jaspr n=15; Active Control n=5) prior to commencing the full RCT to test both study procedures and Jaspr2.0.

Clinical Trial Description

Jaspr Health ("Jaspr"; R44MH108222) is a service-ready, commercially viable suicide prevention platform originally optimized to deliver suicide prevention evidence-based practices (EBPs) when used by acutely suicidal patients in emergency departments (EDs). Grounded in Jobes' Collaborative Assessment and Management of Suicidality (CAMS), Jaspr guides patients in completing a comprehensive suicide risk assessment and lethal means counseling, builds a crisis stabilization plan, and teaches behavioral skills to reduce imminent distress; videos of people with lived experience (PLE) offer wisdom and hope for getting through suicide crises. Information is summarized for the care team to aid in discharge disposition planning. Jaspr includes a companion app for home use to provide care transition support post-discharge. Results from a randomized controlled trial (RCT; N=31) comparing it to Care-as-Usual (CAU) strongly support its feasibility, acceptability, and effectiveness in increasing use of EBPs, reducing agitation and distress, improving capacity to cope with suicidal thoughts and improving ED satisfaction. Also, 100% of the 105 acutely suicidal ED patients who participated in all research phases recommended Jaspr for others in their situation. Jaspr's careful alignment with healthcare systems' (HCS) ED needs has led to rapid commercial adoption since completion of the RCT in 2020, with paid pilot tests in five EDs, and a contract to implement Jaspr in 13 EDs within a large Midwest HCS in 2021.

This 34-month fast track seeks to adapt Jaspr for primary care (Jaspr 2.0) and significantly expand its use to increase public health impact: (1) focus on those who are experiencing suicidal ideation only; (2) extend its utility to CAMS treatment; and (3) include an alcohol module when alcohol use disorder (AUD) is interfering with the ability to address and treat suicide drivers and/or is exacerbating the patient's primary problems. The CAMS approach will guide the integration of AUD EBPs. Investigators will design Jaspr for several primary care provider (PCP) use cases: serving as a real-time tool to guide PCPs in treating suicidal behaviors, as a treatment adjunct for patients to use on their own as "homework" in between PCP visits, and as a self-help tool for use during the care transition while waiting for mental health outpatient services.

Investigators will conduct a 12-week intent-to-treat RCT with 120 suicidal adults 18 years and older. Participants will again be recruited through Mayo Clinic and social media (to ensure sufficient participant flow, participant diversity, and participants with AUD). Participants will be randomly assigned to Jaspr2.0 (n=60) or an active control condition (n=60) including Virtual Hope Box, a well-regarded suicide prevention self-help app, plus an electronic wellness resources brochure containing links to health and wellness materials, psychoeducation about suicide, depression, self-help recovery-focused resources (e.g., Alcoholics Anonymous and other 12-Step programs, Moderation Management, etc.), and phone/text information for the National Suicide Prevention Lifeline. Participants will be assessed at baseline, 4, 8 and 12 weeks. Primary outcome variables include: suicidal behaviors (ideation, planning), self-efficacy and coping with suicidal thoughts and distress, and use of evidence-based strategies to cope with distress (behavioral skills, use of a crisis stability plan). Secondary outcome variables will include alcohol misuse and suicide attempts (considered secondary outcome due to the low base rate). App satisfaction and use of technology outcomes (i.e., degree of usage, features used) will be examined and reported descriptively.

Investigators hypothesize that in comparison to the active control condition, Jaspr2.0 participants will show significantly better outcomes from baseline to the 4, 8, and 12 week assessment points such that:

1. Jaspr participants will report significantly greater decreases in suicidal and alcohol misuse behaviors compared to study controls.

2. Jaspr participants will report significantly greater increases in self-efficacy and coping with suicidal thoughts and distress, as well as use of suicide prevention strategies compared to study controls.

3. Jaspr participants will report a higher degree of satisfaction with their respective app compared to controls with theirs. ;

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Use Disorder
• Alcoholism
• Suicidal Ideation
• Suicide
• Suicide, Attempted

• NCT number: NCT05427734
• Study type: Interventional
• Source: Evidence-Based Practice Institute, Seattle, WA
• Contact: Daniela Mendez Faria
• Phone: 206-455-7934
• Email: research@jasprhealth.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Completion date: August 31, 2024