Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors

Suicide Ideation Clinical Trial

Official title:

Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318962
• Other study ID #: UMemphis
• Secondary ID: SPC-1000007404 G
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: August 1, 2027

Study information

• Verified date: March 2024
• Source: University of Memphis
• Contact: Michael Rudd, Ph.D.
• Phone: 901-456-0580
• Email: mdrudd[@]memphis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 <30% and we anticipate similar rates in this trial.

Description:

See Attached Documents

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression/Anxiety
• Suicidal Behaviors
• Suicide
• Suicide Ideation

Intervention

Behavioral:
• Aviva
Digital phone app for BCBT

Locations

Country	Name	City	State
United States	Fort Carson	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Memphis

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bryan C.J., Rudd M.D. Guilford Press; 2018. Brief cognitive-behavioral therapy for suicide prevention.

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.cb — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Injurious Thoughts and Behaviors Interview Revised	Suicide Attempts, self-injury and suicidal ideation	At intake, 3 months, 6 months, 9 months and 12 months
Secondary	Beck Scale for Suicide Ideation	Suicidal ideation	At intake, 3 months, 6 months, 9 months and 12 months
Secondary	Beck Hopelessness Scale	Hopelessness	At intake, 3 months, 6 months, 9 months and 12 months