Suicide Prevention for at-risk Servicemembers
Digital therapeutic, Aviva, potentially important solution to challenges associated with the implementation of evidence-based strategies into clinical practice.
The University of Memphis has been awarded funding for the study “Use of a Brief Cognitive Behavioral Digital Therapeutic in Primary Care to Reduce Suicide Risk in a Military Population (at Fort Carson, Colorado).” This is a coordinated effort and partnership project housed at The Ohio State University; the overall effort includes five separate studies targeting reducing suicide risk in active-duty military servicemembers. The PI for the $2.2M University of Memphis project is Dr. M. David Rudd, Distinguished Professor of Psychology; the overall fund effort is $8.5M.
Two recently completed DoD-sponsored randomized clinical trials (RCTs) support the effectiveness of brief cognitive behavioral therapy for suicide prevention (BCBT) and crisis response planning (CRP). In those studies, BCBT reduced suicide attempts by 60% and CRP reduced suicide attempts by 76% among treatment-seeking Servicemembers. Unfortunately, fewer than half of Servicemembers who die by suicide visit a specialty mental health clinic in the months leading up to their death, limiting the potential reach and availability of BCBT. Identifying strategies that expand access to BCBT, even among Servicemembers who do not access specialty mental healthcare, could result in significant reductions in military suicide. Intervening with soldiers in a primary care setting holds considerable promise to reduce suicide risk.
Aviva, a 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. In light of these promising early results, the primary aim of this project is to test the efficacy of the Aviva app among Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. The digital therapeutic, Aviva, was created by a company Rudd helped create called Oui Therapeutics.
The study will be conducted in primary care clinics at Fort Carson, with a goal of enrolling 350 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 app or control. The control condition will include development of a safety plan 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. Participants will also complete weekly check[1]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 complete follow-up assessments at 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. Impact: 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.
Protocol fidelity for evidence-based suicide prevention strategies is highly variable in routine clinical practice. In light of evidence that high fidelity is important for reducing patient suicidality, the Aviva app provides a potentially important solution to the considerable challenges associated with the implementation of evidence-based strategies into clinical practice. Because this study will be conducted in military primary care clinics, their results will also provide valuable knowledge about how empirically-supported strategies could be scaled to reach a much larger number of at-risk Servicemembers, including those who decline or refuse referrals for specialty mental health, and/or underreport the severity of their suicide risk due to concerns about possible career impact. The present study will therefore provide much-needed evidence supporting the use of an innovative tool that expands the potential reach of military suicide prevention efforts.
For more information on this study, contact Rudd at mdrudd@memphis.edu.