Trials / Completed
CompletedNCT03584386
CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 357 (actual)
- Sponsor
- Evidence-Based Practice Institute, Seattle, WA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | V-CAMS (aka Jaspr) | V-CAMS is an integrated software system for use on any device by suicidal patients. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2018-07-12
- Last updated
- 2021-04-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03584386. Inclusion in this directory is not an endorsement.