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

University of Washington

Status: Completed

Conditions: Suicide

Treatments: Device: V-CAMS (aka Jaspr)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03584386

R44MH108222

Details and patient eligibility

About

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.

Enrollment: 357 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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357 participants in 2 patient groups

V-CAMS (aka Jaspr)

Experimental group

Description:

In Phase I (formative), participants are asked to provide feedback on the V-CAMS prototype as it is being refined. Feedback will be gathered via survey measure and interview. Phase II (summative): Patient participants enrolled in the ED RCT will be randomly assigned to this arm and will be given access to the V-CAMS 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 at 7 days, 30 days, and 90 days. Outpatient participants in the Telehealth RCT will be randomly assigned to receive the V-CAMS/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 sample for ED RCT is defined as completing post-treatment baseline assessment; telehealth study intent to treat threshold is defined as completing setup of JAH on their personal mobile phone.

Treatment:

Device: V-CAMS (aka Jaspr)

Care As Usual

No Intervention group

Description:

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. 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 sample for ED RCT is defined as completing post-treatment baseline assessment; telehealth study intent to treat threshold is defined as setting up the control condition crisis stability plan.