Clinical trial NCT03584386: CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention
Official title: CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicidality
Collaborative Assessment and Management of Suicidality
CAMS
Technology
Emergency Department
Suicide Intervention
Suicide Assessment
Suicide Prevention
Self-Help Device
Assistive Technology
Lead sponsor: Evidence-Based Practice Institute, Seattle, WA
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
name: Allina Health
name: Wake Forest University Health Sciences
name: Harborview Injury Prevention and Research Center
name: The Catholic University of America
First posted: 2018-07-12
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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, the Virtual-CAMS (V-CAMS, formerly called CAMS-RAS), 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 V-CAMS, including readiness for electronic health record integration; (2) Cultivate and utilize the advisory board so that V-CAMS 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=90) of suicidal ED patients comparing V-CAMS (n=45) to Care-As-Usual (CAU; n=45). Participants will be assessed at baseline while in the ED, and again at 7, 30, and 90 days. The investigators predict that V-CAMS 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. V-CAMS is now known as Jaspr Health ("Jaspr"). A telehealth clinical trial will be conducted with suicidal outpatients to compare the Jaspr-At-Home companion mobile app (JAH; n=30) and CAU (in addition to crisis safety planning; n=30). Participants will be assessed at baseline, 30- and 90-days after the initial session.


Eligibility criteria: Inclusion Criteria applicable to all:

* 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:

* 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:

1. 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
2. Have made a suicide attempt in the last six months or
3. 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:

1. 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)
2. For those in outpatient context, patient is not in imminent risk for suicide as deemed by their treatment provider
3. 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

Exclusion Criteria applicable to all:

* 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

Primary outcomes:
measure: Change in Suicide Cognitions Scale (SCS)
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in Coping Skills Use
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in Client Satisfaction Questionnaire (CSQ)
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in Safety & Imminent Distress Scale (SIDQ)
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in the Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Baseline, 30 days, and 90 days.
measure: Change in Suicide-Related Coping Scale (SRCS)
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in Suicide Attempt and Self-Injury Questions
timeFrame: Baseline, 30 days, and 90 days.
measure: Change in the Suicide Behaviors Questionnaire - Revised (SBQ-R)
timeFrame: Baseline, 30 days, and 90 days.
measure: Change in Outpatient Satisfaction Questionnaire
timeFrame: Baseline, 30 days, and 90 days.
measure: Change in Jaspr-At-Home Patient Satisfaction Survey
timeFrame: Baseline, 30 days, and 90 days.
Secondary outcomes:
measure: Usability Satisfaction and Acceptability Questionnaire (USAQ)
timeFrame: Up to one day
measure: Change in Provider Ratings Questionnaire
timeFrame: Baseline, 7 days, 30 days, and 90 days.
measure: Change in Optimism & Hope Scale
timeFrame: Baseline, 7 days, 30 days, and 90 days.
Other outcomes:
measure: Semi-Structured Interview
timeFrame: Up to one day
Locations:
city: Seattle
country: United States
facility: Evidence-Based Practice Institute
state: Washington
Study officials:
affiliation: Evidence-Based Practice Institute
name: Linda Dimeff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of America
name: David A Jobes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.