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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 Suicide Ideation and Suicidal Behaviors, sponsored by University of Memphis.

Recruiting
Registry status
NA
Development phase
400
Enrollment target
1
Study location

NCT06318962 is a NA study of Suicide Ideation and Suicidal Behaviors that is actively recruiting participants, run by University of Memphis. The registered enrollment target is 400 participants, above the 333-participant average among 7 other Suicide Ideation trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06318962, a NA study of Suicide Ideation and Suicidal Behaviors, 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

Interventions

  • BEHAVIORAL Aviva

Study Locations (1)

Colorado

  • Fort Carson - Colorado Springs

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2024-02-07
Est. Completion 2027-08-01
Phase NA

Sponsor

University of Memphis

35 total trials

What the Registry Record Tells You About NCT06318962

The ClinicalTrials.gov registry entry for NCT06318962 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 333-participant average among 7 other Suicide Ideation trials with a reported enrollment target (20% higher). The listed sponsor is University of Memphis, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Suicide Ideation appearing as the primary indexed condition, and to 1 intervention - of which Aviva is the first listed.

NCT06318962 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Suicide Ideation, Suicidal Behaviors, Depression/Anxiety.

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.

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