Treating Drivers of Suicide Using Jaspr Health

• ClinicalTrials.gov Identifier: NCT05427734
• Recruitment Status: Not yet recruiting
• First Posted: June 22, 2022
• Last Update Posted: June 28, 2023
• Sponsor: Evidence-Based Practice Institute, Seattle, WA
• Information provided by (Responsible Party): Evidence-Based Practice Institute, Seattle, WA

Tracking Information

• First Submitted Date: June 15, 2022
• First Posted Date: June 22, 2022
• Last Update Posted Date: June 28, 2023
• Estimated Study Start Date: September 15, 2023
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2022)

• Change in Patient Health Questionnaire-9 [ Time Frame: Eligibility Screening (time 0), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) ]
  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.
• Change in Alcohol Use Disorders Identification Test [ Time Frame: Eligibility Screening (time 0), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) ]
  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).
• Change in Suicidal Behaviors Questionnaire-Revised [ Time Frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) ]
  Four-item self-report measure that assesses suicide attempts, ideation, communication, and intent since the last assessment. The SBQ-R has excellent internal consistency (α = .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.
• Change in Suicide-Related Coping Scale [ Time Frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 17, 2022)

• Change in Suicide Attempt Self-Injury Interview [ Time Frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4) ]
  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.
• App Satisfaction Survey [ Time Frame: 12 weeks (time 4) ]
  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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 17, 2022)

• Demographics Questionnaire [ Time Frame: Eligibility Screening (time 0) ]
  Self-report measure to collect demographics from participants in this study. Questions include items about gender, race, and ethnicity.
• Ask Suicide Screening Questions [ Time Frame: Eligibility Screening (time 0) ]
  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.
• Drug Abuse Screening Test [ Time Frame: Eligibility Screening (time 0) ]
  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.
• Columbia-Suicide Severity Rating Scale [ Time Frame: Eligibility Screening (time 0) ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Treating Drivers of Suicide Using Jaspr Health
• Official Title: Treating Drivers of Suicide in Primary Care Using Jaspr Health

Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Suicide
• Suicide, Attempted
• Suicidal Ideation
• Alcohol Use Disorder
• Alcoholism
• Alcohol Abuse
• Screening and Brief Interventions

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.
• Device: 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.

Study Arms

• Experimental: Jaspr2.0
  Suicide prevention platform that includes evidence-based practices for suicide prevention and alcohol misuse for use in primary care. Jaspr2.0 includes psychoeducation, behavioral skills training, crisis stabilization planning, lethal means management, brief interventions for the treatment of alcohol misuse, and messages of hope, wisdom, and insights from people with lived experience (PLE). Participants in this condition will also have access to the Jaspr2.0 companion mobile app, Jaspr-at-Home.
  Intervention: Device: Jaspr2.0
• Active Comparator: Active-Control app + electronic wellness resources brochure
  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, other 12-Step programs, Moderation Management, etc.), and phone/text information for the National Suicide Prevention Lifeline.
  Intervention: Device: Active-Control app + electronic wellness resources brochure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 17, 2022): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2024
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Daniela Mendez Faria; 206-455-7934; research@jasprhealth.com

Contact: Angela Kelley Brimer; 206-455-7934; research@jasprhealth.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05427734
• Other Study ID Numbers: R44AA029868( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@jasprhealth.com.

The final dataset will include self-reported demographic and behavioral data from participants in the randomized controlled trial. The dataset will include sensitive data from participants regarding suicidal behavior and substance use. Even though the final dataset will be stripped of identifiers prior to release for sharing, investigators believe that there remains the possibility of deductive disclosure of participants. Thus, the de-identified dataset will be distributed by Drs. Dimeff and Jobes to those that request it and only under a data-sharing agreement that includes: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate security protections; and (3) a commitment to destroying the data after analyses are completed.

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Study data will become available after grant closeout, in perpetuity.
• Access Criteria: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate security protections; and (3) a commitment to destroying the data after analyses are completed.

• Current Responsible Party: Evidence-Based Practice Institute, Seattle, WA
• Original Responsible Party: Same as current
• Current Study Sponsor: Evidence-Based Practice Institute, Seattle, WA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Linda A. Dimeff, PhD; Chief Scientific Officer

• PRS Account: Evidence-Based Practice Institute, Seattle, WA
• Verification Date: June 2023