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SuicideV-CAMSNCT03584386

CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention

A study testing Jaspr and Jaspr-at-Home (JAH) in people with Suicide, run by Evidence-Based Practice Institute, Seattle, WA at 1 site in United States.

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

This Phase II study is a continuation of the Phase I feasibility study where the investigators fully met and exceeded project aims to design, build, and test the usability and acceptability of an avatar-based system, Jaspr Health ("Jaspr"), for use by suicidal ED patients and medical personnel responsible for their… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide
What is being tested?
Jaspr and Jaspr-at-Home (JAH)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 31 Mar 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • English speaker
  • Have access to a computer or other device (smartphone, tablet) with Internet connection
  • Have access and regularly use an Apple or Android smartphone
  • Have a stable address and housing for the last 30 days
  • ED RCT Inclusion Criteria:
Show all 19Show fewer
  • Clinically stable Suicidal Patient* currently admitted to the ED, psychiatric inpatient unit, and medical floors of the participating sites; Suicidal Patients currently receiving outpatient mental health services
  • Hospital medical personnel who treat suicidal patients, hospital administrators, hospital-based peer advocates, and outpatient mental health clinicians and administrators
  • "Suicidal Patient" is defined as those patients who:
  • Have explicitly indicated to their treatment provider that they are suicidal and/or are seeking treatment in part because they want to kill themselves or
  • Have made a suicide attempt in the last six months or
  • Engaged in non-suicidal self-injurious behaviors with high suicidal ideation (defined as 4 to 5 on a 0-5 point Likert scale) in the past three months.
  • "Clinically Stable" and not in clear and imminent danger is defined as:
  • Patients who are oriented to time, place, person and are no longer in acute phase of distress that led to their ED admission (for those in the ED)
  • For those in outpatient context, patient is not in imminent risk for suicide as deemed by their treatment provider
  • In all cases, patient is able to follow instructions for mood improvement/distress tolerance protocol to help stabilize their mood; current status is unlikely to worsen as a result of engagement with research staff in study activities as deemed by their treatment provider.
  • The Site Contact or Coordinators and/or designated medical staff will determine if suicidal patients fit these criteria before referring them to the research team.
  • Telehealth RCT Inclusion Criteria:
  • Currently receiving outpatient treatment services for suicidality

Who cannot join

  • Acutely psychotic and thus unable to provide informed consent
  • Severely agitated (as deemed by physician, nurse, or outpatient therapist)
  • Not fluent in English
  • Additional Exclusion Criteria for Telehealth RCT only:
  • Prior use of Jaspr or Jaspr-At-Home app

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Evidence-Based Practice Institute

    Seattle, Washington, 98126

Other trials in United States

About this study

This Phase II study is a continuation of the Phase I feasibility study where the investigators fully met and exceeded project aims to design, build, and test the usability and acceptability of an avatar-based system, Jaspr Health ("Jaspr"), for use by suicidal ED patients and medical personnel responsible for their care. Phase II includes a formative phase, during which the investigators will continue conducting usability and acceptability tests of new features, and a summative phase to conduct a clinical trial. SBIR Phase II project aims include: (1) Complete development of Jaspr, including readiness for electronic health record integration; (2) Cultivate and utilize the advisory board so that Jaspr is positioned to meet the needs of diverse healthcare systems and successful conduct of the proposed research; (3) Conduct usability/acceptability tests of new features with target end-users (suicidal patients, including those in the ED, medical providers) and key stakeholders (i.e., administrators); and (4) Conduct a randomized controlled trial (RCT; n=31) of suicidal ED patients comparing Jaspr (n=14) to Care-As-Usual (CAU; n=17). Participants were assessed at baseline while in the ED, and again at 7, 30, and 90 days. The investigators predicted that Jaspr participants will report a significantly greater decrease in suicidal behaviors and ED/hospital admissions, as well as significantly greater increases in use of behavioral coping skills, self-efficacy in coping with distress, and perceived helpfulness of patients' ED experience and satisfaction with the app. This study, however, was paused due to COVID after February, 2020 with a total of 31 participants recruited. The study later resumed at one site; however, because of COVID there were fewer admissions for suicidal behavior to the ED, only 7 participants were enrolled before the study ended recruitment in December, 2020 (RCT; n=7) (Jaspr; n=4) (CAU; n=3). The Telehealth clinical trial was conducted with suicidal outpatients to compare the Jaspr-At-Home companion mobile app (JAH; n=28) and CAU (in addition to crisis safety planning; n=26). Participants were assessed at baseline, 30- and 90-days after the initial session.

Conditions
Suicide
Being tested
Jaspr, Jaspr-at-Home (JAH)
Keywords
Suicidality, Collaborative Assessment and Management of Suicidality, CAMS, Technology, Emergency Department, Suicide Intervention, Suicide Assessment, Suicide Prevention, Self-Help Device, Assistive Technology
Medical subject headings
Suicide, Suicidal Ideation, Emergencies, Suicide Prevention

What participants receive

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

  • JasprDevice

    Jaspr is an integrated software system for use on any device by suicidal patients.

  • Jaspr-at-Home (JAH)Device

    Jaspr-at-Home is the mobile companion app to Jaspr.

Study groups in NCT03584386
Study groupRoleWhat they receive
Jaspr (ED RCT) / JAH (Telehealth RCT)ExperimentalED RCT: Phase I (formative): Participants are asked to provide feedback on the Jaspr prototype as it is being refined. Feedback will be gathered via survey measure and interview. Phase II (summative): Patient participants will be randomly assigned to this arm and will be given access to the Jaspr tools as part of their treatment in the ED. Baseline assessment surveys will be administered in the ED, and three follow up assessments after discharge will occur at 7 days, 30 days, and 90 days. Intent to treat sample is defined as completing post-treatment baseline assessment. Telehealth RCT: Outpatient participants will be randomly assigned to receive the Jaspr companion mobile app JAH in addition to their usual outpatient care. Study assessments will be administered remotely at three time points: baseline, 30- and 90-day follow ups. Intent to treat threshold is defined as completing setup of JAH on their personal mobile phone.
Receives: Device: Jaspr; Device: Jaspr-at-Home (JAH)
Care As UsualNo interventionED RCT: Phase II (summative): Patient participants enrolled in the ED RCT will be randomly assigned to this arm so there is an even number of participants in the experimental condition and this condition. Those assigned to this condition will be treated as usual in the ED. Same as the experimental condition, those in the Care As Usual condition will be asked to complete baseline assessment surveys while they are waiting in the ED, and then three subsequent assessments after discharge at 7 days, 30 days, and 90 days. Intent to treat sample is defined as completing post-treatment baseline assessment. Telehealth RCT: Outpatient participants enrolled in the Telehealth RCT will be randomly assigned to CAU in addition to receiving crisis safety planning. Study assessments will be administered remotely at baseline and at 30- and 90-day follow ups. Intent to treat threshold is defined as setting up the control condition crisis stability plan.

What is being measured

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

  1. Change in Suicide Cognitions Scale (SCS)

    An 18-item psychometrically sound self-report measure, the Suicide Cognitions Scale (SCS) assesses suicidal schemas. Items are scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree). The score is found by summing the items for a total ranging from 18 to 90 with higher scores indicating worse outcomes. The scale is administered to patient participants at three time-points during the Telehealth RCT to assess change over time.

    Measured: Baseline, 30 days, and 90 days.

  2. Change in Suicide Related Coping Scale (SRCS)

    17-item, with 5 items scored in reverse, psychometrically-sound self-report measure of coping with suicidal thoughts, urges, and crises that uses a 5-point rating scale (0=strongly disagree; 4=strongly agree); the items are summed, so total range of the scale is 0 to 68, with higher scores indicating higher suicide related coping. It is administered to patient participants at three time-points during Telehealth RCT.

    Measured: Baseline, 30 days, and 90 days.

  3. Emergency Room Patient Satisfaction Survey

    A seven-item measure frequently used in clinical trials, modified for this study to focus on patient participants' emergency department. The Emergency Room Patient Satisfaction Survey is scored by summing the individual items to produce a range of 1 to 5, with higher scores indicating greater satisfaction. It is administered to patient participants at baseline during Phase II (summative) of the ED RCT.

    Measured: Baseline.

  4. Change in Safety & Imminent Distress Scale (SIDQ)

    A four-item self-report scale modified for this study to measure emotional distress and self-efficacy in coping with suicidality. For agitation, scores are 1=very calm to 10=very frustrated/agitated. For ability to cope, scores are 1=no ability to cope with thoughts of killing myself to 10=strong ability to cope with thoughts of killing myself. For distress, scores are 1=no distress to 10= the highest distress you have ever felt. Each item is averaged with lower values representing better outcomes for agitation and distress, and higher values representing better outcomes for ability to cope. It is administered to patient participants at each assessment point during Phase II (summative) ED RCT.

    Measured: Baseline, 7 days, 30 days, and 90 days.

  5. Change in Depression Anxiety and Stress Scale (DASS-21)

    A 21-item self-report measure frequently used in clinical trials, used to measure emotional states of depression, anxiety, and stress. The DASS-21 contains three subscales, depression, anxiety, and stress with seven items each. Each item was rated on a four point scale from 1 (Did not apply to me at all) to 4 (Applied to me very much or most of the time). Subscale totals are obtained by summing the seven item scores and multiplying by two to produce a range of 14 to 56 for each. Higher scores indicate higher severities of depression, anxiety, and stress. It is administered to patient participants at three time-points during the Phase II (summative) Telehealth RCT.

    Measured: Baseline, 30 days, and 90 days.

  6. Change in Suicide-Related Coping Scale (SRCS)

    This 17-item self-report measure, with 5-items reverse scored, is designed to assess a participant's capacity to cope effectively with their suicidal thoughts. Each item is rated on five point Likert scale from 0 (Strongly Disagree) to 4 (Strongly Agree). These items are summed, resulting in a scale range from 0 to 68, where higher scores indicate higher suicide related coping. It is administered to patient participants at each assessment time-points during Phase II (summative) ED RCT.

    Measured: Baseline, 7 days, 30 days, and 90 days.

  7. Outpatient Satisfaction Questionnaire

    An eight-item self-report measure to assess patient satisfaction with the care they received, perception of provider, and readiness to maintain safety. Items are rated on a scale of 1 (poor) to 5 (excellent), with higher scores indicating higher levels of satisfaction. It is administered to patient participants at baseline during Phase II (summative) Telehealth RCT.

    Measured: Baseline

  8. Jaspr-At-Home Patient Satisfaction Survey

    A 12-item self-report measure assessing the usability and satisfaction of the JAH mobile app. Items are averaged, resulting a scale range from 1 (Poor) to 5 (Excellent); higher scores indicate higher satisfaction and usability. It is administered to patient participants at two time-points during Phase II (summative) Telehealth RCT.

    Measured: 30 days and 90 days.

  9. Jaspr Health Patient Satisfaction Survey

    An 8-item self-report measure assessing the usability and satisfaction of the Jaspr app. Items are averaged, resulting in a scale range from 1(Poor) to 5 (Excellent). Higher scores indicate higher ease of use, helpfulness of the app, feeling cared about by the app, and helpfulness of information provided in the app. It is administered to patient participants at baseline during Phase II (summative) ED RCT.

    Measured: Baseline.

  10. Change in Nock Intensity Rating Scale

    This 6-item self-report measure is designed to assess a participant's intensity levels related to suicidal thoughts and ability to cope. Each item serves as its own subscale, and are individually scored and rated on a ten point Likert scale from 1 (Not at all) to 10 (Very Strong). For the desire and intention subscales, higher scores indicate worse outcomes. For the resist, safe, cope, and hope subscales, higher scores indicate better outcomes. It is administered to patient participants at each assessment time-points during Phase II (summative) ED and Telehealth RCT.

    Measured: Baseline, 7 days, 30 days, and 90 days.

Secondary outcomes (1)
  1. Change in Optimism & Hope Scale

    A 14-item self-report measure to assess optimism and hope. Items are scored on a 4-point Likert scale (1=definitely true; 4=definitely false). A total score, 14-56, is obtained by summing scores for each item. The mean score (minimum= 1; maximum= 4) is then calculated by dividing the total score by the number of items in the measure. Lower scores indicate increased optimism and hope. It is administered to patient participants at each assessment time-point during the Telehealth RCT and ED RCT.

    Measured: Baseline, 7 days, 30 days, and 90 days.

Timeline

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

  1. First posted12 Jul 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03584386
Sponsor's protocol ID
R44MH108222
Acronym
V-CAMS
Status last verified
Apr 2022
First submitted
11 Jun 2018
Last updated
14 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org

Publications

  • Dimeff LA, Jobes DA, Koerner K, Kako N, Jerome T, Kelley-Brimer A, Boudreaux ED, Beadnell B, Goering P, Witterholt S, Melin G, Samike V, Schak KM. Using a Tablet-Based App to Deliver Evidence-Based Practices for Suicidal Patients in the Emergency Department: Pilot Randomized Controlled Trial. JMIR Ment Health. 2021 Mar 1;8(3):e23022. doi: 10.2196/23022.

    PubMed 33646129

Questions about this trial

What is this clinical trial studying?

A study testing Jaspr and Jaspr-at-Home (JAH) in people with Suicide, run by Evidence-Based Practice Institute, Seattle, WA at 1 site in United States.

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 19 inclusion and 5 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 14 Oct 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Suicide Cognitions Scale (SCS) (time frame: Baseline, 30 days, and 90 days.). The study lists 10 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 NCT03584386, 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 14 Oct 2026.

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