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NCT06318962 · ClinicalTrials.gov registry record · NA
Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
A NA study of Depression, Anxiety and Suicide Ideation, sponsored by University of Memphis.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT06318962: Recruiting NA study of Depression, Anxiety and Suicide Ideation, sponsored by University of Memphis.
NCT06318962 is a NA study of Depression, Anxiety and Suicide Ideation that is actively recruiting participants, run by University of Memphis. The registered enrollment target is 400 participants, roughly in line with the 415-participant average among 40 other Depression, Anxiety trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06318962, a NA study of Depression, Anxiety and Suicide Ideation, is actively recruiting participants, sponsored by University of Memphis.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions 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 and/or 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 (i.e. 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
Primary Outcome
Suicide Attempts, self-injury and suicidal ideation
Conditions Studied
Interventions
- BEHAVIORAL Aviva
Study Locations (1)
Colorado
- Fort Carson - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-02-07 |
| Est. Completion | 2027-08-01 |
| Phase | NA |
What NCT06318962 shows while recruiting
NCT06318962 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 415-participant average among 40 other Depression, Anxiety trials with a reported enrollment target.
The record links to 3 conditions, with Depression, Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Aviva is the first listed.
NCT06318962 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06318962 about?
NCT06318962 is a clinical study titled "Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors". The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interve...
What is the current status of trial NCT06318962?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-02-07. Estimated completion is 2027-08-01.
What conditions does trial NCT06318962 study?
This clinical trial studies the following conditions: Depression, Anxiety, Suicide Ideation, Suicidal Behaviors.
What interventions are being tested in trial NCT06318962?
The interventions under investigation include: Aviva (BEHAVIORAL).
Who is sponsoring clinical trial NCT06318962?
This trial is sponsored by University of Memphis, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06318962 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06318962's enrollment target sits among peer trials
400 8th of 40 higher than 32 of 40 other Depression, Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression, Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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