Testing a Digital Behavioral Therapy App to Reduce Suicidal Thoughts and Behaviors in Adults
Led by University of Memphis · Updated on 2026-05-05
400
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a digital behavioral therapy app called Aviva for servicemembers who have recently experienced suicidal thoughts or attempts. The study aims to improve access to Brief Cognitive Behavioral Therapy BCBT through a smartphone platform, addressing challenges in delivering suicide prevention treatments with fidelity. This research will help determine which intervention strategies work best and how they can be delivered effectively in primary care settings.
Participants will be randomly assigned to use Aviva, a digital app delivering BCBT, or to a control group that receives a safety plan app and standard mental health care. The Aviva group will also have weekly check-ins with research clinicians to monitor treatment adherence and address any concerns. The study plans to enroll 720 patients over two years at primary care clinics, with follow-up assessments at baseline, 3, 6, 9, and 12 months.
During the study, participants will complete measures of self-injurious thoughts and behaviors, suicidal ideation, and hopelessness at multiple time points. Researchers will track app engagement, suicidal beliefs, and decision-making to understand how the intervention affects outcomes. Safety monitoring is included, and data from all participants will be analyzed using intent-to-treat principles. The total study duration for each participant includes assessments across one year.
CONDITIONS
Brief Title
Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
Research Team
M
Michael Rudd, Ph.D.
M
Michelle Wine, Ph.D.
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Aviva app (BCBT‑based digital therapeutic)
Treatment as usual
What it is
A smartphone‑based app delivering brief cognitive‑behavioral therapy (BCBT) techniques to reduce suicidal ideation and behaviors
Standard care that participants would normally receive without the app
Role in the trial
Investigational behavioral therapeutic intervention delivered via app
Control condition reflecting usual treatment without the app
Primary use
Being studied to prevent suicidal ideation and behaviors in adults reporting recent suicidal thoughts or attempts
Represents current management without digital adjunct, reflecting standard clinical care
How it is given or performed
Delivered on participants’ smartphones through app modules based on BCBT; frequency and duration per trial protocol
Usual clinical care without the investigational digital therapeutic
Evidence status
Efficacy is currently being evaluated; results not yet available
Efficacy reflects existing usual care practices; not formally studied in this trial
Important risks
Not specified; risks not described in registry
Not specified; usual care risks not characterized in study context
Important limitations
Effectiveness unknown until trial completes; smartphone ownership and ability to consent required—may limit access
Usual care may vary widely across settings, making comparisons less consistent
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
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 an Apple iPhone iOS 11 or higher or an Android smartphone OS 8.1 or higher
Experiencing active psychosis or mania requiring hospitalization
Inability to use a smartphone
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Outpatient Treatment
Duration - Up to 12 months
Participants use the Aviva digital therapeutic app for brief cognitive behavioral therapy (BCBT) to help prevent suicidal behaviors.
Assessments at intake, 3 months, 6 months, 9 months, and 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up.
M David Rudd, Craig J Bryan, Evelyn G Wertenberger...
Examining the efficacy of a digital therapeutic to prevent suicidal ideation and behaviors in a primary care setting: Design and methodology of a randomized controlled trial with military service members.