Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318962
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-26
Brief Title:
Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
Sponsor:
University of Memphis
Organization:
University of Memphis
Study Overview
Official Title:
Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform ie smartphone to Servicemembers with recent suicidal ideation andor suicide attempts presenting to primary care clinics Given existing challenges of scaling empirically-supported treatmentsinterventions for suicidality with fidelity this project could lead to markedly expanded access to BCBT along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity Aviva the digital version of BCBT was developed for use with patients across the full spectrum of healthcare settings including primary care Aviva is not an emergency alert system rather a digital platform for delivery of the full scope of BCBT treatment components An open-label single group Phase I clinical trial has demonstrated the safety tolerability feasibility fidelity and potential efficacy of Aviva with participants completing modules over 8 weeks and follow-up assessments at weeks 1 4 and 8 Subsequent refinements included the addition of technical features that would allow patients to revisit andor repeat previously completed modules along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement These modifications have further enhanced Aviva safety tolerability and fidelity consistent with the original BCBT protocol Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition but also that greater app engagement will be negatively correlated with severity of suicidal thinking Moderators and mediators ie suicidal beliefs wish to live impulsive decision-making of intervention effects will also be examined The study will be conducted at the primary care clinics at Fort Carson with a goal of enrolling 720 patients across a two-year timeframe Participants will be identified using each clinics existing suicide risk assessment methods including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener Recent Participants will be randomly assigned to one of two treatment conditions Aviva or control ie development of a safety plan consistent with local procedures and policies along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures In an effort to address potential performance bias specific to smartphone use participants in the control condition will download the Suicide Safety Plan app to their smartphones Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence identify and respond to any logisticaloperational problems and respond to any unexpected emergencies andor participant safety concerns Participants will have up to five data points baseline 3 6 9 and 12 months All data available from all participants and all time points will be included in the analyses consistent with the intent-to-treat principle Across our two previous clinical trials and our in-progress RCT attrition during the first 12 months postbaseline was lt30 and we anticipate similar rates in this trial
Detailed Description:
See Attached Documents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPC-1000007404 GR127268 | OTHER | Department of Defense | None |