Clinical trial NCT06318962: Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
Official title: Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Behaviors
Suicide Ideation
Depression/Anxiety
Keywords: BCBT
Suicide Ideation
Suicide Attempts
Depression and Anxiety
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 \&lt;30% and we anticipate similar rates in this trial.

Detailed description: See Attached Documents

Eligibility criteria: 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.

Primary outcomes:
measure: Self Injurious Thoughts and Behaviors Interview Revised
timeFrame: At intake, 3 months, 6 months, 9 months and 12 months
Secondary outcomes:
measure: Beck Scale for Suicide Ideation
timeFrame: At intake, 3 months, 6 months, 9 months and 12 months
measure: Beck Hopelessness Scale
timeFrame: At intake, 3 months, 6 months, 9 months and 12 months
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Fort Carson
state: Colorado
Study officials:
References:
citation: Bryan C.J., Rudd M.D. Guilford Press; 2018. Brief cognitive-behavioral therapy for suicide prevention.
citation: Rudd MD, Bryan CJ, Wertenberger EG, Peterson AL, Young-McCaughan S, Mintz J, Williams SR, Arne KA, Breitbach J, Delano K, Wilkinson E, Bruce TO. 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. Am J Psychiatry. 2015 May;172(5):441-9. doi: 10.1176/appi.ajp.2014.14070843. Epub 2015 Feb 13.
citation: Rojas SM, Gold SD, Bryan CJ, Pruitt LD, Felker BL, Reger MA. Brief Cognitive-Behavioral Therapy for Suicide Prevention (BCBT-SP) via Video Telehealth: A Case Example During the COVID-19 Outbreak. Cogn Behav Pract. 2022 May;29(2):446-453. doi: 10.1016/j.cbpra.2020.12.001. Epub 2021 Feb 4.