Treating Drivers of Suicide Using Jaspr Health

Alcohol Use Disorder Clinical Trial

Official title:

Treating Drivers of Suicide in Primary Care Using Jaspr Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05427734
• Other study ID #: R44AA029868
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2023
• Source: Evidence-Based Practice Institute, Seattle, WA
• Contact: Daniela Mendez Faria
• Phone: 206-455-7934
• Email: research[@]jasprhealth.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years of age

• English speaking

• Currently has a primary care provider and sought care from them in the past year

• Owns and is the primary user of an Android- or Apple-based smartphone with data plan

• Scores 1 or greater on Item 9 of the Patient Health Questionnaire-9 (PHQ-9)

To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.

Exclusion Criteria:

• Severe depression (PHQ-9 score of 20 or greater)

• Alcohol dependence (AUDIT score of 15 or greater)

• Acutely suicidal (affirms item 5 of the Ask Suicide Screening Questions)

• Significant drug abuse problems (scores 11 or greater on the Drug Abuse Screening test)

Individuals who are excluded because of the severity of their depression, suicide acuity, and/or degree of substance use disorder will be provided with resources (i.e., National Suicide Prevention Lifeline, this study's crisis hotline number (Boys Town), SAMHSA's National Helpline) and encouraged to reach out to their primary care provider.

Related Conditions & MeSH terms

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

Intervention

Device:
• Jaspr2.0
Participants assigned to this condition will receive access to Jaspr2.0 and its companion mobile app, Jaspr-at-Home, for 12 weeks.
• Active-Control app + electronic wellness resources brochure
Participants assigned to this condition will receive access to Virtual Hope Box, a well-regarded suicide prevention self-help app, for 12 weeks plus an electronic wellness resources brochure.

Locations

Country	Name	City	State
United States	Evidence-Based Practice Institute, Inc.	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Evidence-Based Practice Institute, Seattle, WA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics Questionnaire	Self-report measure to collect demographics from participants in this study. Questions include items about gender, race, and ethnicity.	Eligibility Screening (time 0)
Other	Ask Suicide Screening Questions	A five-item brief validated screening tool for youth and adults and developed by NIMH researchers to help healthcare providers identify individuals at risk for suicide. ASQ Item 5 assesses immediate acuity of suicidality. All items are yes or no questions.	Eligibility Screening (time 0)
Other	Drug Abuse Screening Test	10-item psychometrically validated self-administered screening tool for drug-related problems. Each question answered "yes" is scored as 1 point (question 3 is reverse-scored) and total is summed where 0 is no problems reported through 10, severe level of problems related to drug abuse.	Eligibility Screening (time 0)
Other	Columbia-Suicide Severity Rating Scale	A FDA-recommended tool to assess suicidal behaviors in healthcare systems. Investigators will use the C-SSRS items to assess suicide attempts for purposes of the eligibility screening. It contains 6 yes or no questions.	Eligibility Screening (time 0)
Primary	Change in Patient Health Questionnaire-9	9-item self-report measure (minimum of 0 and maximum of 27) that assesses recent depressive symptoms, and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. Scores of 1-9 indicate minimal to mild depression; 10-14, moderate depression; 15-19, moderately severe depression; and 20-27, severe depression.	Eligibility Screening (time 0), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Primary	Change in Alcohol Use Disorders Identification Test	10-item psychometrically sound self-report measure (minimum of 0 and maximum of 40) used in a variety of healthcare settings worldwide to assess alcohol intake, potential dependence on alcohol, and experience of alcohol-related harm. Scores from 8 to 15 suggest hazardous or harmful alcohol consumption and a score of 16 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).	Eligibility Screening (time 0), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Primary	Change in Suicidal Behaviors Questionnaire-Revised	Four-item self-report measure that assesses suicide attempts, ideation, communication, and intent since the last assessment. The SBQ-R has excellent internal consistency (a = .83), sensitivity and specificity (.80 and .91, respectively). Items are summed producing a total ranging from 3 to 18, with higher scores indicating higher severity.	Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Primary	Change in Suicide-Related Coping Scale	17-item psychometrically-sound self-report measure (minimum of 0 and maximum of 68) of coping with suicidal thoughts, urges, and crises that uses a 5-point rating scale (0=strongly disagree; 4=strongly agree). Higher scores indicate higher ability to cope with suicidality.	Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Secondary	Change in Suicide Attempt Self-Injury Interview	A gold-standard interviewer-administered instrument used to gather information about the occurrence of suicidal and NSSI, including the frequency, intent, medical severity, outcomes for each event during the assessment window, as well as healthcare utilization associated with suicidal behavior. Includes a six-item self-report measure assessing frequency of engagement in suicidal or self-injurious behaviors as well as the frequency of seeking assistance from emergency room, professional, or crisis line for suicidal or self-injurious behaviors in the past three months.	Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Secondary	App Satisfaction Survey	An eight-item survey used in EBPI's earlier research, which focuses on an app's ease of use and helpfulness. The initial six items use a five-point rating scale (1=poor; 5=excellent). Users also provide an overall satisfaction rating for their condition app using a 100-point scale and indicate whether they would recommend using the app to others in their situation.	12 weeks (time 4)