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.
