Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors

May 4, 2026 updated by: University of Memphis
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 720 patients across a two-year timeframe. Participants will be identified using each clinic's 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 (i.e., 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 logistical/operational problems, and respond to any unexpected emergencies and/or 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 <30% and we anticipate similar rates in this trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

See Attached Documents

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80829
        • Recruiting
        • Fort Carson
        • Contact:
        • Principal Investigator:
          • Michelle Wine, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • at least 18 years old
  • suicidal ideation within the past week and/or a suicide attempt within the past 30 days
  • ability to complete the informed consent process
  • ownership of either an Apple iPhone iOS 11 or higher or an Android smartphone OS 8.1 or higher

Exclusion Criteria:

  • an inability to complete informed consent procedures (e.g., acute intoxication, altered consciousness)
  • experiencing active psychosis or mania requiring hospitalization; (3) and inability to use a smartphone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual
Experimental: Digital Therapeutic
BCBT Delivery via digital app
Behavioral: Aviva
Digital phone app for BCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Injurious Thoughts and Behaviors Interview Revised
Time Frame: At intake, 3 months, 6 months, 9 months and 12 months
Suicide Attempts, self-injury and suicidal ideation
At intake, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Scale for Suicide Ideation
Time Frame: At intake, 3 months, 6 months, 9 months and 12 months
Suicidal ideation
At intake, 3 months, 6 months, 9 months and 12 months
Beck Hopelessness Scale
Time Frame: At intake, 3 months, 6 months, 9 months and 12 months
Hopelessness
At intake, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Memphis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMemphis
  • SPC-1000007404 GR127268 (Other Identifier: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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